South African National Clinical Trials Registry
South African Medical Research Council, Cochrane South Africa
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: sactradmin@mrc.ac.za Website: sanctr.samrc.ac.za
Trial no.: DOH-27-092021-9206 Date of Approval: 13/09/2021
Trial Status: Approved
TRIAL DESCRIPTION
Public title A First Time in Human Phase 1 Open-Label Study of the Safety, Tolerability, and Immunogenicity of COVIDITY Vaccine Administered by Needle-free ID Injection or Needle-free IM Injection in Healthy Adults
Official scientific title A First Time in Human Phase 1 Open-Label Study of the Safety, Tolerability, and Immunogenicity of COVIDITY Vaccine Administered by Needle-free ID Injection or Needle-free IM Injection in Healthy Adults
Brief summary describing the background and objectives of the trial Plasmid DNA vaccines, such as the prototype ImmunoBody® SCIB1 melanoma vaccine (Scancell, Oxford, United Kingdom), are designed to be taken up by antigen presenting cells, which synthesise the encoded antigen of interest, process the antigens and present epitopes on either major histocompatibility complex class I or II molecules. T cells recognising these complexes then act as amplifiers of the immune response (CD4 helper T cells) or direct effectors of tumour cell attack (CD8 cytotoxic T lymphocytes) (Metheringham et al 2009). Exploiting a dual mechanism of action, secreted ImmunoBody proteins can also be engineered to incorporate an Fc binding domain that binds to the Fc receptor (FcR) on dendritic cells leading to enhanced uptake and further amplification of the T cell response. In addition to the endogenous production and processing of proteins to create T cell responses, secretion of these proteins will also elicit B-cell mediated humoral responses. Using this concept, the COVIDITY vaccine was designed to enable enhanced FcR targeting of the SARS-CoV-2 nucleocapsid (N) protein to stimulate a high avidity CD8 T cell response, as well as an S protein receptor-binding domain (RBD) component to stimulate VNAbs (data on file). The possibility of vaccine enhanced disease has previously hindered the development of vaccines against respiratory viruses (Vennema et al 1990). However, in contrast to most other COVID 19 vaccines, COVIDITY encodes the RBD rather than the complete S protein as this is not necessary to generate VNAbs, and this may help to avoid T helper 2 responses that could potentially trigger immune pathologies. Primary Objective: To assess the safety and tolerability of COVIDITY administered by needle free ID or IM injection. Secondary Objectives: To assess the immunogenicity of COVIDITY administered by needle-free ID or IM injection.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19 infection prevention
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/08/2021
Actual trial start date 30/09/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 24/11/2022
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 67
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group COVIDITY Participants enrolled under CSP Amendment 1 • ID administration: For administration using the PharmaJet Tropis® needle-free injection device. Each administration will comprise one 0.1 mL injection of Scancell plasmid DNA vaccine to deliver a dose of 0.2 mg. Note: Any participants who have not yet received their first dose of SCOV2 at the time of CSP Amendment 2 implementation will receive 0.8 mg ID delivered as four 0.1 mL injections. • IM administration: For administration using the PharmaJet Stratis® needle-free injection device. Each administration will comprise one 0.5 mL injection of Scancell plasmid DNA vaccine to deliver a dose of 1 mg. Note: Any participants who have not yet received their first dose of SCOV2 at the time of CSP Amendment 2 implementation will receive 4 mg IM delivered as four 0.5 mL injections. Participants enrolled from CSP Amendment 2 onwards • ID administration: For administration using the PharmaJet Tropis® needle-free injection device. Each administration will comprise four 0.1 mL injections of Scancell plasmid DNA vaccine to deliver a dose of 0.8 mg. • IM administration: For administration using the PharmaJet Stratis® needle-free injection device. Each administration will comprise four 0.5 mL injections of Scancell plasmid DNA vaccine to deliver a dose of 4 mg. Ongoing participants enrolled under CSP Amendment 1 After a screening period of up to 15 days, participants will receive SCOV1 injections on Day 1 and Day 29. The first SCOV2 injection will be given at the earliest available opportunity from Day 113 (between Day 113 and Day 169), with the second SCOV2 injection occurring 4 weeks later (between Day 141 and Day 197). Final assessments for safety and immunogenicity will occur 6 weeks after the second SCOV2 injection. Total participation is therefore expected to be between 28 and 36 weeks. Vaccine-naïve and previously vaccinated populations After a screening period of up to 15 days, participants will receive SCOV2 injections on Day 1 and Day 29. Final assessments for safety and immunogenicity will occur 6 weeks after the second SCOV2 injection. Total participation is therefore expected to be approximately 12 weeks. Previously infected population After a screening period of up to 15 days, participants will receive a single SCOV2 injection on Day 1. Final assessments for safety and immunogenicity will occur 6 weeks later. Total participation is therefore expected to be approximately 8 weeks. COVIDITY consists of two vaccines (SCOV1 and SCOV2). SCOV1 is expected to be active against the original SARS-CoV-2 strain and the B.1.1.7 (Alpha) variant, and to a slightly lesser extent against the B.1.351 (Beta) and P.1 (Gamma) variants. SCOV2 is expected to boost the effects of SCOV1 while providing further enhanced protection against the B.1.351 (Beta) and P.1 (Gamma) variants. Antibodies induced by SCOV1 and SCOV2 also show strong binding to the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants in nonclinical models. 80
Control Group NA N/A N/A N/A 0 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1 Able and willing to provide written informed consent prior to any study procedure 2 18 to 59 years of age 3 Male or non-pregnant female 4 No known exposure to SARS-CoV-2 virus in the last 14 days and has a negative RT-PCR SARS-CoV-2 lab test within 48 hours prior to the first study vaccination administration 5 Determined by the Investigator to be healthy 6 Comply with study procedures 7 Women of child-bearing potential must have a negative urine pregnancy test during screening & a negative serum pregnancy test on Day -1 prior to the first dose of study vaccine & be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods 8 Men who are potentially fertile must agree to use barrier protection for the duration of their participation in the study & until 120 days after administration of the last dose of study vaccine; they also agree to request their female partners to use an effective method of contraception 9 Oral temperature of less than 37.5C at screening & prior to dosing 10 Screening ECG with none of the following: • PR-interval >210 msec • QRS-duration >120 msec • QT-interval >500 msec • Corrected QT-interval by Fridericia (QTcF)-interval >450 ms • Pathologic Q wave • Significant ST-T wave changes • Second or third-degree atrioventricular heart block. 11 Refrain from donating blood or plasma 12 Participant agrees not to consume any alcohol within 48 hours prior to each study vaccine administration and has a negative alcohol breath test prior to the first administration of the study vaccine 1 History of proven SARS-CoV-2 infection during 28 days prior to 1st administration of COVIDITY 2 Received a COVID-19, other vaccination or booster during the 28 days prior to 1st administration of COVIDITY 3 History of chronic respiratory disease, hypertension, significant cardiovascular or autoimmune disease, immunodeficiency, clotting disorder, history of thrombosis or malignancy 4 Any medical disease or psychiatric condition which in the opinion of the Investigator would preclude participation 5 Positive result for hep B, hep C or HIV types 1/2 antibodies at screening 6 Alcohol consumption of >21 units/week (males), >14 units/week (females) 7 History of strenuous exercise within 96 hrs prior to administration of 1st study vaccination 8 Participated in another study within 30 days or 5 half-lives before 1st study vaccine in current study 9 Currently enrolled in/plans to participate in another study with an investigational product to be received during study reporting period 10 History of any vaccine/drug hypersensitivity reactions or other clinically significant allergies 11 History of chronic use of any medicine that may be associated with impaired immune responsiveness 12 Prescription medicine within 14 days/5 half lives of 1st study vaccine, use of over-the-counter medicine/herbal supplements within 7 days 13 Immunoglobulins and/or any blood/blood products within 90 days before 1st study vaccine or any time during study 14 History of alcohol abuse/other recreational drug use within 6 months before 1st study vaccine 15 Positive result for urine drugs of abuse at screening/prior 1st study vaccine administration (positive cannabis result is acceptable for recreational use) 16 Received an experimental SARS-CoV-2 vaccine other than SCOV1 17 Pregnant, lactating or planning/wanting to conceive/father children during study 18 Findings on screening biochemistry, haematology, coagulation tests or urinalysis 19 Other reason investigator deems participation unsuitable Adult: 18 Year(s)-44 Year(s) 18 Year(s) 59 Year(s) Both
APPROVALS
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/07/2021 SAHPRA
Ethics Committee Address
Street address City Postal code Country
SAHPRA Head Office, Building A, Loftus Park, 2nd Floor, 402 Kirkness Street, Arcadia Pretoria 0083 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2021 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room G50, G Floor, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary Endpoints: The safety and tolerability of COVIDITY will be assessed by: a) The frequency and severity of adverse events (AEs) b) The frequency of serious adverse events (SAEs) c) The frequency and severity of local and systemic reactogenicity events d) The development of any new-onset chronic medical conditions Ongoing and end of study
Secondary Outcome Secondary Endpoints: The immunogenicity of COVIDITY will be assessed by: a) Change from baseline in quantitative COVIDITY-specific antibody responses measured by enzyme-linked immunosorbent assay (ELISA) or using the Meso Scale Discovery (MSD) platform b) The proportion of participants who seroconvert and/or have an increase in N ± S protein antibody titre from baseline c) Change from baseline in quantitative COVIDITY-specific T cell responses measured by enzyme-linked immunospot (ELISpot) assay Ongoing and end of study.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Province Country
University of Cape Town Lung Institute Centre for Tuberculosis Research Innovation George Street, Mowbray Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Province Country
Scancell Limited John Eccles House Robert Robinson Avenue Oxford Science Park Oxford Oxfordshire United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Scancell Limited Bellhouse Building, Sanders Road, Oxford Science Park Oxford OX4 4GD United Kingdom Commercial Sector/Industry
COLLABORATORS
Name Street address City Province Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rodney Dawson rodney.dawson@uct.ac.za +27214066864 University of Cape Town Lung Institute Centre for Tuberculosis Research Innovation George Street Mowbray
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Managing Director of UCT Lung Institute and Principal Investigator
Role Name Email Phone Street address
Public Enquiries Fayaz Master FayazMaster@scancell.co.uk +447540726162 John Eccles House Robert Robinson Avenue Oxford Science Park Oxford Oxfordshire OX4 4GP
City Postal code Country Position/Affiliation
Oxfordshire OX4 4GP United Kingdom Clinical Operations
Role Name Email Phone Street address
Scientific Enquiries Robert Miller RobertMiller@scancell.co.uk +441865582690 Scancell Limited John Eccles House Robert Robinson Avenue Oxford Science Park Oxford
City Postal code Country Position/Affiliation
Oxfordshire OX4 4GP United Kingdom Medical Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes It is expected that the results of this study will be published and/or presented at scientific meetings. The Investigator agrees to submit all manuscripts and abstracts to the Sponsor before submission. The Investigator shall provide the Sponsor thirty (30) days to review a manuscript or any poster presentation, abstract or other written or oral material that describes the results of the trial for the purpose only of determining if any confidential or patentable information is disclosed thereby. If the Sponsor requests in writing, the Investigator shall withhold any publication or presentation an additional sixty (60) days solely to permit the Sponsor to seek patent protection. The Sponsor will comply with the requirements for publication of study results as detailed in “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” (www.ICMJE.org). Publication of the results will occur in a timely manner according to applicable regulations. The Sponsor will generally support publication of multicentre studies only in their entirety and not as individual investigational centre data. Authorship will be determined by mutual agreement and in line with the following International Committee of Medical Journal Editors authorship requirements: • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work. • Drafting the work or revising it critically for important intellectual content. • Final review and approval of the version to be published. • Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Clinical Study Report One to three months after database lock Request for access to trial data to be sent to Sponsor
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/07/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/07/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 06/07/2022 Updated due to approved Protocol Amendment V2 Plasmid deoxyribose nucleic acid (DNA) vaccines, such as the prototype ImmunoBody® SCIB1 melanoma vaccine (Scancell, Oxford, United Kingdom), are designed to be taken up by antigen presenting cells, which synthesise the encoded antigen of interest, process the antigens and present epitopes on either major histocompatibility complex (MHC) class I or II molecules. T cells recognising these complexes then act as amplifiers of the immune response (CD4 helper T cells) or direct effectors of tumour cell attack (CD8 cytotoxic T lymphocytes) (Metheringham et al 2009). Exploiting a dual mechanism of action, secreted ImmunoBody proteins can also be engineered to incorporate an Fc binding domain that binds to the Fc receptor (FcR) on dendritic cells leading to enhanced uptake and further amplification of the T cell response. In addition to the endogenous production and processing of proteins to create T cell responses, secretion of these proteins will also elicit B-cell mediated humoral responses. Using this concept, the COVIDITY vaccine was designed to enable enhanced FcR targeting of the SARS-CoV-2 nucleocapsid (N) protein to stimulate a high avidity CD8 T cell response, as well as an S protein receptor-binding domain (RBD) component to stimulate VNAbs (data on file). The possibility of vaccine enhanced disease has previously hindered the development of vaccines against respiratory viruses (Vennema et al 1990). However, in contrast to most other COVID 19 vaccines, COVIDITY encodes the RBD rather than the complete S protein as this is not necessary to generate VNAbs, and this may help to avoid Th2 responses that could potentially trigger immune pathologies. Primary Objective: To assess the safety and tolerability of COVIDITY administered by needle free ID injection or needle-free IM injection. Secondary Objectives: To assess the immunogenicity of COVIDITY administered by needle-free ID injection or needle-free IM injection. Plasmid DNA vaccines, such as the prototype ImmunoBody® SCIB1 melanoma vaccine (Scancell, Oxford, United Kingdom), are designed to be taken up by antigen presenting cells, which synthesise the encoded antigen of interest, process the antigens and present epitopes on either major histocompatibility complex (MHC) class I or II molecules. T cells recognising these complexes then act as amplifiers of the immune response (CD4 helper T cells) or direct effectors of tumour cell attack (CD8 cytotoxic T lymphocytes) (Metheringham et al 2009). Exploiting a dual mechanism of action, secreted ImmunoBody proteins can also be engineered to incorporate an Fc binding domain that binds to the Fc receptor (FcR) on dendritic cells leading to enhanced uptake and further amplification of the T cell response. In addition to the endogenous production and processing of proteins to create T cell responses, secretion of these proteins will also elicit B-cell mediated humoral responses. Using this concept, the COVIDITY vaccine was designed to enable enhanced FcR targeting of the SARS-CoV-2 nucleocapsid (N) protein to stimulate a high avidity CD8 T cell response, as well as an S protein receptor-binding domain (RBD) component to stimulate VNAbs (data on file). The possibility of vaccine enhanced disease has previously hindered the development of vaccines against respiratory viruses (Vennema et al 1990). However, in contrast to most other COVID 19 vaccines, COVIDITY encodes the RBD rather than the complete S protein as this is not necessary to generate VNAbs, and this may help to avoid Th2 responses that could potentially trigger immune pathologies. Primary Objective: To assess the safety and tolerability of COVIDITY administered by needle free ID injection or needle-free IM injection. Secondary Objectives: To assess the immunogenicity of COVIDITY administered by needle-free ID injection or needle-free IM injection.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 06/07/2022 Updated due to approved Protocol Amendment V2 Plasmid DNA vaccines, such as the prototype ImmunoBody® SCIB1 melanoma vaccine (Scancell, Oxford, United Kingdom), are designed to be taken up by antigen presenting cells, which synthesise the encoded antigen of interest, process the antigens and present epitopes on either major histocompatibility complex (MHC) class I or II molecules. T cells recognising these complexes then act as amplifiers of the immune response (CD4 helper T cells) or direct effectors of tumour cell attack (CD8 cytotoxic T lymphocytes) (Metheringham et al 2009). Exploiting a dual mechanism of action, secreted ImmunoBody proteins can also be engineered to incorporate an Fc binding domain that binds to the Fc receptor (FcR) on dendritic cells leading to enhanced uptake and further amplification of the T cell response. In addition to the endogenous production and processing of proteins to create T cell responses, secretion of these proteins will also elicit B-cell mediated humoral responses. Using this concept, the COVIDITY vaccine was designed to enable enhanced FcR targeting of the SARS-CoV-2 nucleocapsid (N) protein to stimulate a high avidity CD8 T cell response, as well as an S protein receptor-binding domain (RBD) component to stimulate VNAbs (data on file). The possibility of vaccine enhanced disease has previously hindered the development of vaccines against respiratory viruses (Vennema et al 1990). However, in contrast to most other COVID 19 vaccines, COVIDITY encodes the RBD rather than the complete S protein as this is not necessary to generate VNAbs, and this may help to avoid Th2 responses that could potentially trigger immune pathologies. Primary Objective: To assess the safety and tolerability of COVIDITY administered by needle free ID injection or needle-free IM injection. Secondary Objectives: To assess the immunogenicity of COVIDITY administered by needle-free ID injection or needle-free IM injection. Plasmid DNA vaccines, such as the prototype ImmunoBody® SCIB1 melanoma vaccine (Scancell, Oxford, United Kingdom), are designed to be taken up by antigen presenting cells, which synthesise the encoded antigen of interest, process the antigens and present epitopes on either major histocompatibility complex class I or II molecules. T cells recognising these complexes then act as amplifiers of the immune response (CD4 helper T cells) or direct effectors of tumour cell attack (CD8 cytotoxic T lymphocytes) (Metheringham et al 2009). Exploiting a dual mechanism of action, secreted ImmunoBody proteins can also be engineered to incorporate an Fc binding domain that binds to the Fc receptor (FcR) on dendritic cells leading to enhanced uptake and further amplification of the T cell response. In addition to the endogenous production and processing of proteins to create T cell responses, secretion of these proteins will also elicit B-cell mediated humoral responses. Using this concept, the COVIDITY vaccine was designed to enable enhanced FcR targeting of the SARS-CoV-2 nucleocapsid (N) protein to stimulate a high avidity CD8 T cell response, as well as an S protein receptor-binding domain (RBD) component to stimulate VNAbs (data on file). The possibility of vaccine enhanced disease has previously hindered the development of vaccines against respiratory viruses (Vennema et al 1990). However, in contrast to most other COVID 19 vaccines, COVIDITY encodes the RBD rather than the complete S protein as this is not necessary to generate VNAbs, and this may help to avoid T helper 2 responses that could potentially trigger immune pathologies. Primary Objective: To assess the safety and tolerability of COVIDITY administered by needle free ID or IM injection. Secondary Objectives: To assess the immunogenicity of COVIDITY administered by needle-free ID or IM injection.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 06/07/2022 New information 30 Sep 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 06/07/2022 New information and updated due to Protocol Amendment V2 31 May 2022 31 Dec 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 14/12/2022 Confirmed date of completion 24 Nov 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 06/07/2022 Updated due to Protocol Amendment V2 40 80
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 14/12/2022 Confirmed final number of participants 67
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 11/10/2021 Study status has changed and study is open for recruitment Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 24/10/2022 Study has reached the recruitment target. Enrolment is closed. Recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 25/11/2022 All study participants have completed the study visits as per the protocol. Closed to recruitment,follow-up continuing Completed
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation to intervention 10/09/2021 Selected correct intervention for study design Randomised Non-randomised
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation to intervention 06/07/2022 Updated due to approved Protocol Amendment V2 Non-randomised Randomised
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 06/07/2022 Updated due to approved Protocol Amendment V2 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification
Section Name Field Name Date Reason Old Value Updated Value
Study Design Stratification factors 06/07/2022 Updated due to approved Protocol Amendment V2 According to prior SARS-CoV-2 infection and COVID-19 vaccination status.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 06/07/2022 Updated due to approved Protocol Amendment V2 1) Provide written informed consent prior to any study procedure 2) 18 to 59 years of age 3) Male or non-pregnant female 4) No known exposure to SARS-CoV-2 virus in the last 14 days and has a negative RT-PCR SARS-CoV-2 laboratory test 24–48 hours prior to initial vaccination 5) SARS-CoV-2 antibodies: a. Negative for SARS-CoV-2 antibodies, or b. Positive for SARS-CoV-2 antibodies with no known clinical history of COVID-19 infection 6) Determined by the Investigator to be healthy on the basis of medical history, physical examination, vital signs, and routine laboratory tests 7) Comply with study procedures, including the collection of venous blood & to be available for all study visits 8) Women of child-bearing potential must have a negative urine pregnancy test at Screening & a negative serum pregnancy test on Day -1 (prior to the first dose) and be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods 9) Men who are potentially fertile must agree to use barrier protection when they engage in sexual relations with women who are of child-bearing potential, pregnant, or lactating; they also agree to request their female partners to use an effective method of contraception 10) Oral temperature of less than 37.5 degrees C at screening & prior to dosing 11) Screening ECG with none of the following clinically significant findings: - PR-interval >210msec - QRS-duration >120msec - QT-interval >500msec - Corrected QT-interval by Fridericia (QTcF)-interval >450msec (males), >470msec (females) - Pathologic Q wave - Significant ST-T wave changes - Second or third-degree atrioventricular heart block 12) Refrain from donating blood or plasma, outside of the study, for the duration of study participation and for 28 days after the last dose of study vaccine 13) Participant agrees not to consume any alcohol within 48 hours prior to each study vaccine administration 1) Able and willing to provide written informed consent prior to any study procedure 2) 18 to 59 years of age 3) Male or non-pregnant female 4) No known exposure to SARS-CoV-2 virus in the last 14 days and has a negative RT-PCR SARS-CoV-2 lab test within 48 hours prior to the first study vaccination administration 5) Determined by the Investigator to be healthy 6) Comply with study procedures 7) Women of child-bearing potential must have a negative urine pregnancy test during screening & a negative serum pregnancy test on Day -1 prior to the first dose of study vaccine & be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods 8) Men who are potentially fertile must agree to use barrier protection for the duration of their participation in the study & until 120 days after administration of the last dose of study vaccine; they also agree to request their female partners to use an effective method of contraception 9) Oral temperature of less than 37.5C at screening & prior to dosing 10) Screening ECG with none of the following: • PR-interval >210 msec • QRS-duration >120 msec • QT-interval >500 msec • Corrected QT-interval by Fridericia (QTcF)-interval >450 ms • Pathologic Q wave • Significant ST-T wave changes • Second or third-degree atrioventricular heart block. 11) Refrain from donating blood or plasma 12) Participant agrees not to consume any alcohol within 48 hours prior to each study vaccine administration and has a negative alcohol breath test prior to the first administration of the study vaccine
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 06/07/2022 Updated due to approved Protocol Amendment 2 1) Able and willing to provide written informed consent prior to any study procedure 2) 18 to 59 years of age 3) Male or non-pregnant female 4) No known exposure to SARS-CoV-2 virus in the last 14 days and has a negative RT-PCR SARS-CoV-2 lab test within 48 hours prior to the first study vaccination administration 5) Determined by the Investigator to be healthy 6) Comply with study procedures 7) Women of child-bearing potential must have a negative urine pregnancy test during screening & a negative serum pregnancy test on Day -1 prior to the first dose of study vaccine & be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods 8) Men who are potentially fertile must agree to use barrier protection for the duration of their participation in the study & until 120 days after administration of the last dose of study vaccine; they also agree to request their female partners to use an effective method of contraception 9) Oral temperature of less than 37.5C at screening & prior to dosing 10) Screening ECG with none of the following: • PR-interval >210 msec • QRS-duration >120 msec • QT-interval >500 msec • Corrected QT-interval by Fridericia (QTcF)-interval >450 ms • Pathologic Q wave • Significant ST-T wave changes • Second or third-degree atrioventricular heart block. 11) Refrain from donating blood or plasma 12) Participant agrees not to consume any alcohol within 48 hours prior to each study vaccine administration and has a negative alcohol breath test prior to the first administration of the study vaccine 1 Able and willing to provide written informed consent prior to any study procedure 2 18 to 59 years of age 3 Male or non-pregnant female 4 No known exposure to SARS-CoV-2 virus in the last 14 days and has a negative RT-PCR SARS-CoV-2 lab test within 48 hours prior to the first study vaccination administration 5 Determined by the Investigator to be healthy 6 Comply with study procedures 7 Women of child-bearing potential must have a negative urine pregnancy test during screening & a negative serum pregnancy test on Day -1 prior to the first dose of study vaccine & be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods 8 Men who are potentially fertile must agree to use barrier protection for the duration of their participation in the study & until 120 days after administration of the last dose of study vaccine; they also agree to request their female partners to use an effective method of contraception 9 Oral temperature of less than 37.5C at screening & prior to dosing 10 Screening ECG with none of the following: • PR-interval >210 msec • QRS-duration >120 msec • QT-interval >500 msec • Corrected QT-interval by Fridericia (QTcF)-interval >450 ms • Pathologic Q wave • Significant ST-T wave changes • Second or third-degree atrioventricular heart block. 11 Refrain from donating blood or plasma 12 Participant agrees not to consume any alcohol within 48 hours prior to each study vaccine administration and has a negative alcohol breath test prior to the first administration of the study vaccine
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 06/07/2022 Updated due to approved Protocol Amendment V2 1) History of chronic respiratory disease, hypertension, significant cardiovascular disease, autoimmune disease, immunodeficiency, clotting disorder, history of thrombosis, or malignancy (some exceptions). 2) Any medical disease or condition, or psychiatric condition, which in the opinion of the Investigator would preclude study participation. 3) Positive test result for hep B, hep C, or HIV types 1 or 2 antibodies at screening. 4) Alcohol consumption of >21 units per week (males) or >14 units per week (females). 5) Strenuous exercise within 96 hours of screening and the first dosing visit. 6) Participated in another investigational study involving an investigational product within 30 days, or 5 half-lives before the first study vaccine in the current study. 7) Currently enrolled in or plans to participate in another clinical trial with an investigational product that will be received during the study reporting period. 8) History of any vaccine or drug hypersensitivity reactions, or other known clinically significant allergies. 9) History of chronic use of any medications that may be associated with impaired immune responsiveness. 10) Prescription medications within 14 days or 5 half lives of first study vaccine, use of over-the-counter medications or herbal supplements within 7 days (some exceptions). 11) Immunoglobulins and/or any blood or blood products within 90 days before the first study vaccine or at any time during the study. 12) Vaccine within 28 days of the first dose of study vaccine. 13) History of alcohol abuse or other recreational drug use within 6 months before the first study vaccine. 14) Positive result for the urine drugs of abuse test at screening or prior to the first study vaccine. 15) Any other SARS-CoV-2 vaccine or experimental coronavirus vaccine at any time prior to the study. 16) Pregnant, lactating, or is expecting to conceive/father children during the study. 17) Any clinically significant abnormal findings on screening lab tests. 1) History of proven infection with SARS-CoV-2 during the 28 days prior to the first planned administration of COVIDITY 2) Received a COVID-19 or other vaccination or booster during the 28 days prior to the first planned administration of COVIDITY 3) History of chronic respiratory disease, hypertension, significant cardiovascular disease, autoimmune disease, immunodeficiency, clotting disorder, history of thrombosis, or malignancy (some exceptions) 4) Any medical disease or condition, or psychiatric condition, which in the opinion of the Investigator would preclude study participation 5) Positive test result for hep B, hep C, or HIV types 1 or 2 antibodies at screening 6) Alcohol consumption of >21 units per week (males) or >14 units per week (females) 7) History of strenuous exercise within 96 hours prior to administration of the first study vaccination 8) Participated in another investigational study involving an investigational product within 30 days, or 5 half-lives before the first study vaccine in the current study 9) Currently enrolled in or plans to participate in another clinical trial with an investigational product that will be received during the study reporting period 10) History of any vaccine or drug hypersensitivity reactions, or other known clinically significant allergies 11) History of chronic use of any medications that may be associated with impaired immune responsiveness 12) Prescription medications within 14 days or 5 half lives of first study vaccine, use of over-the-counter medications or herbal supplements within 7 days (some exceptions) 13) Immunoglobulins and/or any blood or blood products within 90 days before the first study vaccine or at any time during the study 14) Vaccine within 28 days of the first dose of study vaccine 15) History of alcohol abuse or other recreational drug use within 6 months before the first study vaccine
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 06/07/2022 Updated due to approved Protocol Amendment 2 1) History of proven infection with SARS-CoV-2 during the 28 days prior to the first planned administration of COVIDITY 2) Received a COVID-19 or other vaccination or booster during the 28 days prior to the first planned administration of COVIDITY 3) History of chronic respiratory disease, hypertension, significant cardiovascular disease, autoimmune disease, immunodeficiency, clotting disorder, history of thrombosis, or malignancy (some exceptions) 4) Any medical disease or condition, or psychiatric condition, which in the opinion of the Investigator would preclude study participation 5) Positive test result for hep B, hep C, or HIV types 1 or 2 antibodies at screening 6) Alcohol consumption of >21 units per week (males) or >14 units per week (females) 7) History of strenuous exercise within 96 hours prior to administration of the first study vaccination 8) Participated in another investigational study involving an investigational product within 30 days, or 5 half-lives before the first study vaccine in the current study 9) Currently enrolled in or plans to participate in another clinical trial with an investigational product that will be received during the study reporting period 10) History of any vaccine or drug hypersensitivity reactions, or other known clinically significant allergies 11) History of chronic use of any medications that may be associated with impaired immune responsiveness 12) Prescription medications within 14 days or 5 half lives of first study vaccine, use of over-the-counter medications or herbal supplements within 7 days (some exceptions) 13) Immunoglobulins and/or any blood or blood products within 90 days before the first study vaccine or at any time during the study 14) Vaccine within 28 days of the first dose of study vaccine 15) History of alcohol abuse or other recreational drug use within 6 months before the first study vaccine 1) History of proven SARS-CoV-2 infection during the 28 days prior to 1st administration of COVIDITY 2) Received a COVID-19, other vaccination or booster during the 28 days prior to 1st administration of COVIDITY 3) History of chronic respiratory disease, hypertension, significant cardiovascular or autoimmune disease, immunodeficiency, clotting disorder, history of thrombosis or malignancy 4) Any medical disease/condition or psychiatric condition which in the opinion of the Investigator would preclude participation 5) Positive result for hep B, hep C or HIV types 1/2 antibodies at screening 6) Alcohol consumption of >21 units per week (males), >14 units per week (females) 7) History of strenuous exercise within 96 hrs prior to administration of 1st study vaccination 8) Participated in another study within 30 days or 5 half-lives before 1st study vaccine in current study 9) Currently enrolled in/plans to participate in another study with an investigational product to be received during study reporting period 10) History of any vaccine/drug hypersensitivity reactions or other known clinically significant allergies 11) History of chronic use of any medicine that may be associated with impaired immune responsiveness 12) Prescription medicine within 14 days/5 half lives of 1st study vaccine, use of over-the-counter medicine/herbal supplements within 7 days 13) Immunoglobulins and/or any blood or blood products within 90 days before 1st study vaccine or any time during study 14) Vaccine within 28 days of 1st dose of study vaccine 15) History of alcohol abuse/other recreational drug use within 6 months before 1st study vaccine
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 06/07/2022 Updated due to approved Protocol Amendment 2 1) History of proven SARS-CoV-2 infection during the 28 days prior to 1st administration of COVIDITY 2) Received a COVID-19, other vaccination or booster during the 28 days prior to 1st administration of COVIDITY 3) History of chronic respiratory disease, hypertension, significant cardiovascular or autoimmune disease, immunodeficiency, clotting disorder, history of thrombosis or malignancy 4) Any medical disease/condition or psychiatric condition which in the opinion of the Investigator would preclude participation 5) Positive result for hep B, hep C or HIV types 1/2 antibodies at screening 6) Alcohol consumption of >21 units per week (males), >14 units per week (females) 7) History of strenuous exercise within 96 hrs prior to administration of 1st study vaccination 8) Participated in another study within 30 days or 5 half-lives before 1st study vaccine in current study 9) Currently enrolled in/plans to participate in another study with an investigational product to be received during study reporting period 10) History of any vaccine/drug hypersensitivity reactions or other known clinically significant allergies 11) History of chronic use of any medicine that may be associated with impaired immune responsiveness 12) Prescription medicine within 14 days/5 half lives of 1st study vaccine, use of over-the-counter medicine/herbal supplements within 7 days 13) Immunoglobulins and/or any blood or blood products within 90 days before 1st study vaccine or any time during study 14) Vaccine within 28 days of 1st dose of study vaccine 15) History of alcohol abuse/other recreational drug use within 6 months before 1st study vaccine 1) History of proven SARS-CoV-2 infection during the 28 days prior to 1st administration of COVIDITY 2) Received a COVID-19, other vaccination or booster during the 28 days prior to 1st administration of COVIDITY 3) History of chronic respiratory disease, hypertension, significant cardiovascular or autoimmune disease, immunodeficiency, clotting disorder, history of thrombosis or malignancy 4) Any medical disease/condition or psychiatric condition which in the opinion of the Investigator would preclude participation 5) Positive result for hep B, hep C or HIV types 1/2 antibodies at screening 6) Alcohol consumption of >21 units per week (males), >14 units per week (females) 7) History of strenuous exercise within 96 hrs prior to administration of 1st study vaccination 8) Participated in another study within 30 days or 5 half-lives before 1st study vaccine in current study 9) Currently enrolled in/plans to participate in another study with an investigational product to be received during study reporting period 10) History of any vaccine/drug hypersensitivity reactions or other known clinically significant allergies 11) History of chronic use of any medicine that may be associated with impaired immune responsiveness 12) Prescription medicine within 14 days/5 half lives of 1st study vaccine, use of over-the-counter medicine/herbal supplements within 7 days 13) Immunoglobulins and/or any blood/blood products within 90 days before 1st study vaccine or any time during study 14) History of alcohol abuse/other recreational drug use within 6 months before 1st study vaccine 15) Positive result for urine drugs of abuse at screening/prior 1st study vaccine administration (a positive cannabis result is acceptable for recreational use) 16) Received an experimental SARS-CoV-2 vaccine other than SCOV1 17) Pregnant, lactating or is planning/wanting to conceive/father children during study 18) clinically significant abnormal findings on screening biochemistry, haematology or coagulatio
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 06/07/2022 Updated due to approved Protocol Amendment 2 1) History of proven SARS-CoV-2 infection during the 28 days prior to 1st administration of COVIDITY 2) Received a COVID-19, other vaccination or booster during the 28 days prior to 1st administration of COVIDITY 3) History of chronic respiratory disease, hypertension, significant cardiovascular or autoimmune disease, immunodeficiency, clotting disorder, history of thrombosis or malignancy 4) Any medical disease/condition or psychiatric condition which in the opinion of the Investigator would preclude participation 5) Positive result for hep B, hep C or HIV types 1/2 antibodies at screening 6) Alcohol consumption of >21 units per week (males), >14 units per week (females) 7) History of strenuous exercise within 96 hrs prior to administration of 1st study vaccination 8) Participated in another study within 30 days or 5 half-lives before 1st study vaccine in current study 9) Currently enrolled in/plans to participate in another study with an investigational product to be received during study reporting period 10) History of any vaccine/drug hypersensitivity reactions or other known clinically significant allergies 11) History of chronic use of any medicine that may be associated with impaired immune responsiveness 12) Prescription medicine within 14 days/5 half lives of 1st study vaccine, use of over-the-counter medicine/herbal supplements within 7 days 13) Immunoglobulins and/or any blood/blood products within 90 days before 1st study vaccine or any time during study 14) History of alcohol abuse/other recreational drug use within 6 months before 1st study vaccine 15) Positive result for urine drugs of abuse at screening/prior 1st study vaccine administration (a positive cannabis result is acceptable for recreational use) 16) Received an experimental SARS-CoV-2 vaccine other than SCOV1 17) Pregnant, lactating or is planning/wanting to conceive/father children during study 18) clinically significant abnormal findings on screening biochemistry, haematology or coagulatio 1 History of proven SARS-CoV-2 infection during 28 days prior to 1st administration of COVIDITY 2 Received a COVID-19, other vaccination or booster during the 28 days prior to 1st administration of COVIDITY 3 History of chronic respiratory disease, hypertension, significant cardiovascular or autoimmune disease, immunodeficiency, clotting disorder, history of thrombosis or malignancy 4 Any medical disease or psychiatric condition which in the opinion of the Investigator would preclude participation 5 Positive result for hep B, hep C or HIV types 1/2 antibodies at screening 6 Alcohol consumption of >21 units/week (males), >14 units/week (females) 7 History of strenuous exercise within 96 hrs prior to administration of 1st study vaccination 8 Participated in another study within 30 days or 5 half-lives before 1st study vaccine in current study 9 Currently enrolled in/plans to participate in another study with an investigational product to be received during study reporting period 10 History of any vaccine/drug hypersensitivity reactions or other clinically significant allergies 11 History of chronic use of any medicine that may be associated with impaired immune responsiveness 12 Prescription medicine within 14 days/5 half lives of 1st study vaccine, use of over-the-counter medicine/herbal supplements within 7 days 13 Immunoglobulins and/or any blood/blood products within 90 days before 1st study vaccine or any time during study 14 History of alcohol abuse/other recreational drug use within 6 months before 1st study vaccine 15 Positive result for urine drugs of abuse at screening/prior 1st study vaccine administration (positive cannabis result is acceptable for recreational use) 16 Received an experimental SARS-CoV-2 vaccine other than SCOV1 17 Pregnant, lactating or planning/wanting to conceive/father children during study 18 Findings on screening biochemistry, haematology, coagulation tests or urinalysis 19 Other reason investigator deems participation unsuitable
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Intervention Intervention List 06/07/2022 Updated due to approved Protocol Amendment V2 Experimental Group, COVIDITY, • Arm 1: SCOV1 (0.2 mg Scancell plasmid DNA vaccine given as a 0.1 mL injection) administered using PharmaJet Tropis® needle free delivery via the ID route at Day 1 and Day 29 (Week 4), and SCOV2 (0.2 mg Scancell plasmid DNA vaccine given as a 0.1 mL injection) not before Days 113 and 141 (Weeks 16 [+8] and 20 [+8] – doses 4 weeks apart). • Arm 2: SCOV1 (1 mg Scancell plasmid DNA vaccine given as a 0.5 mL injection) administered using PharmaJet Stratis® needle free delivery via the IM route at Day 1 and Day 29 (Week 4), and SCOV2 (1 mg Scancell plasmid DNA vaccine given as a 0.5 mL injection) not before Days 113 and 141 (Weeks 16 [+8] and 20 [+8] – doses 4 weeks apart). , After a screening period of up to 15 days, participants will receive SCOV1 injections on Day 1 and Day 29. The first SCOV2 injection will be given at the earliest available opportunity from Day 113 (expected availability is between Day 113 and Day 169), with the second SCOV2 injection occurring 4 weeks later (between Day 141 and D197). Final assessments for safety and immunogenicity will occur 6 weeks after the second SCOV2 injection. Total participation is therefore expected to be between 28 and 36 weeks., COVIDITY comprises 2 plasmid deoxyribonucleic acid (DNA) vaccines: SCOV1 targets the original A lineage of SARS CoV 2 and SCOV2 targets the variants of concern (VoCs), namely the B.1.1.7 (Alpha) variant, the B.1.351 (Beta) variant, and the P.1 (Gamma) variant., 40, Experimental Group, COVIDITY, Participants enrolled under CSP Amendment 1 • ID administration: For administration using the PharmaJet Tropis® needle-free injection device. Each administration will comprise one 0.1 mL injection of Scancell plasmid DNA vaccine to deliver a dose of 0.2 mg. Note: Any participants who have not yet received their first dose of SCOV2 at the time of CSP Amendment 2 implementation will receive 0.8 mg ID delivered as four 0.1 mL injections. • IM administration: For administration using the PharmaJet Stratis® needle-free injection device. Each administration will comprise one 0.5 mL injection of Scancell plasmid DNA vaccine to deliver a dose of 1 mg. Note: Any participants who have not yet received their first dose of SCOV2 at the time of CSP Amendment 2 implementation will receive 4 mg IM delivered as four 0.5 mL injections. Participants enrolled from CSP Amendment 2 onwards • ID administration: For administration using the PharmaJet Tropis® needle-free injection device. Each administration will comprise four 0.1 mL injections of Scancell plasmid DNA vaccine to deliver a dose of 0.8 mg. • IM administration: For administration using the PharmaJet Stratis® needle-free injection device. Each administration will comprise four 0.5 mL injections of Scancell plasmid DNA vaccine to deliver a dose of 4 mg. , Ongoing participants enrolled under CSP Amendment 1 After a screening period of up to 15 days, participants will receive SCOV1 injections on Day 1 and Day 29. The first SCOV2 injection will be given at the earliest available opportunity from Day 113 (between Day 113 and Day 169), with the second SCOV2 injection occurring 4 weeks later (between Day 141 and Day 197). Final assessments for safety and immunogenicity will occur 6 weeks after the second SCOV2 injection. Total participation is therefore expected to be between 28 and 36 weeks. Vaccine-naïve and previously vaccinated populations After a screening period of up to 15 days, participants will receive SCOV2 injections on Day 1 and Day 29. Final assessments for safety and immunogenicity will occur 6 weeks after the second SCOV2 injection. Total participation is therefore expected to be approximately 12 weeks. Previously infected population After a screening period of up to 15 days, participants will receive a single SCOV2 injection on Day 1. Final assessments for safety and immunogenicity will occur 6 weeks later. Total participation is therefore expected to be approximately 8 weeks., COVIDITY consists of two vaccines (SCOV1 and SCOV2). SCOV1 is expected to be active against the original SARS-CoV-2 strain and the B.1.1.7 (Alpha) variant, and to a slightly lesser extent against the B.1.351 (Beta) and P.1 (Gamma) variants. SCOV2 is expected to boost the effects of SCOV1 while providing further enhanced protection against the B.1.351 (Beta) and P.1 (Gamma) variants. Antibodies induced by SCOV1 and SCOV2 also show strong binding to the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants in nonclinical models., 80,
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Outcome OutCome List 06/07/2022 Updated due to approved Protocol Amendment 2 Secondary Outcome, Secondary Endpoints: The immunogenicity of COVIDITY will be assessed by: a) Quantitative COVIDITY-specific antibody responses measured by enzyme-linked immunosorbent assay (ELISA) or using the Meso Scale Discovery (MSD) platform b) The proportion of participants who seroconvert (4-fold change in COVIDITY-specific antibody titre from baseline) c) Quantitative COVIDITY-specific T cell responses measured by enzyme-linked immunospot (ELISpot) assay, Ongoing and end of study. Secondary Outcome, Secondary Endpoints: The immunogenicity of COVIDITY will be assessed by: a) Quantitative COVIDITY-specific antibody responses measured by enzyme-linked immunosorbent assay (ELISA) or using the Meso Scale Discovery (MSD) platform b) The proportion of participants who seroconvert and/or have a 4 fold increase in N ± S protein antibody titre from baseline c) Quantitative COVIDITY-specific T cell responses measured by enzyme-linked immunospot (ELISpot) assay, Ongoing and end of study.
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Outcome OutCome List 03/11/2022 Updated according to protocol amendment V3 Secondary Outcome, Secondary Endpoints: The immunogenicity of COVIDITY will be assessed by: a) Quantitative COVIDITY-specific antibody responses measured by enzyme-linked immunosorbent assay (ELISA) or using the Meso Scale Discovery (MSD) platform b) The proportion of participants who seroconvert and/or have a 4 fold increase in N ± S protein antibody titre from baseline c) Quantitative COVIDITY-specific T cell responses measured by enzyme-linked immunospot (ELISpot) assay, Ongoing and end of study. Secondary Outcome, Secondary Endpoints: The immunogenicity of COVIDITY will be assessed by: a) Change from baseline in quantitative COVIDITY-specific antibody responses measured by enzyme-linked immunosorbent assay (ELISA) or using the Meso Scale Discovery (MSD) platform b) The proportion of participants who seroconvert and/or have an increase in N ± S protein antibody titre from baseline c) Change from baseline in quantitative COVIDITY-specific T cell responses measured by enzyme-linked immunospot (ELISpot) assay, Ongoing and end of study.
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Sponsors Sponsors List 03/11/2022 Sponsor address updated due to relocation of their offices since August 2022. Scancell Limited, John Eccles House Robert Robinson Avenue Oxford Science Park Oxford, Oxfordshire, OX4 4GP, United Kingdom, Primary Sponsor, Commercial Sector/Industry, Scancell Limited, Bellhouse Building, Sanders Road, Oxford Science Park, Oxford, OX4 4GD, United Kingdom, Primary Sponsor, Commercial Sector/Industry,
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Contact People Contacs List 06/07/2022 Updated information for new contact person Public Enquiries, Charlotte, Pires, Dr., CharlottePires@scancell.co.uk, , +447540726162, John Eccles House Robert Robinson Avenue Oxford Science Park Oxford Oxfordshire OX4 4GP, Oxfordshire, OX4 4GP, United Kingdom, Clinical Operations Public Enquiries, Fayaz, Master, Mr., FayazMaster@scancell.co.uk, , +447540726162, John Eccles House Robert Robinson Avenue Oxford Science Park Oxford Oxfordshire OX4 4GP, Oxfordshire, OX4 4GP, United Kingdom, Clinical Operations
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Reporting Result Summary Pdf file1 28/07/2025 Final Published CSR has become available for uploading to SANCTR 5625_473_1050.pdf