Changes to trial information |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Actual trial start date |
26/02/2022 |
Actual start date completed. |
|
13 Dec 2021 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Anticipated date of last follow up |
31/10/2022 |
Recruitment slow and anticipated to complete 04 Nov 2022 |
29 Apr 2022 |
15 May 2023 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Anticipated date of last follow up |
04/05/2023 |
Estimated completion date based on last participant last visit |
15 May 2023 |
15 Jun 2023 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Completion date |
08/12/2023 |
Updating last participant visit |
|
12 Jun 2023 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
|
Trial Information |
Final no of participants |
09/01/2023 |
Update final enrolment |
|
26 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
|
Trial Information |
Final no of participants |
04/05/2023 |
Actual final enrolment status. |
26 |
25 |
Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
26/02/2022 |
Update that study is currently recruiting |
Not yet recruiting |
Recruiting |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
|
Trial Information |
Recruitment status |
09/01/2023 |
Recruitment completed |
Recruiting |
Closed to recruitment,follow-up continuing |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
|
Trial Information |
Recruitment status |
08/12/2023 |
Study closed. |
Closed to recruitment,follow-up continuing |
Completed |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Eligibility |
Exclusion criteria |
31/10/2022 |
Exlusion 8 changed to: SARS-CoV-2 NAAT-positive nasal swab within 48 hours before receipt of study intervention.
Justification:
Timeline of nasal swab results (SARS-CoV-2 NAAT) was prolonged from "within 24 hours" to "within 48 hours" to ensure that results will be obtained on time prior to participant receipt of study vaccine. |
Any medical or psychiatric condition (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
2. Known infection with human immunodeficiency virus (HIV), hepatitis C virus antibody (HCV Ab), or hepatitis B virus antibody (HBV Ab).
3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
4. Receipt of medications intended to prevent COVID-19.
5. Previous vaccination with any coronavirus vaccine.
6. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19
7. Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.
8. SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention.
9. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g., healthcare worker, emergency response personnel).
10. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
11. Women who are pregnant, planning a pregnancy or breastfeeding.
12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
13. Receipt of blood/ |
Any medical or psychiatric condition (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
2. Known infection with human immunodeficiency virus (HIV), hepatitis C virus antibody (HCV Ab), or hepatitis B virus antibody (HBV Ab).
3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
4. Receipt of medications intended to prevent COVID-19.
5. Previous vaccination with any coronavirus vaccine.
6. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19
7. Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.
8. SARS-CoV-2 NAAT-positive nasal swab within 48 hours before receipt of study intervention.
9. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g., healthcare worker, emergency response personnel).
10. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
11. Women who are pregnant, planning a pregnancy or breastfeeding.
12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
13. Receipt of blood/ |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Outcome |
OutCome List |
31/10/2022 |
Secondary Objectives were deleted.
Justification: Secondary objectives were updated and were defined as part of the exploratory objectives.
To describe the immune responses elicited by prophylactic oral PRAK-03202 vaccine as assessed by IgG against VLP titers in healthy volunteers after two doses. Justification:
o present the laboratory measurements that may identify SARS CoV2 by the measurements of (as measured by the developed laboratory kit):
• IgG against VLP titers
• IgA against VLP titers
• Specific T-Cells activation |
Secondary Outcome, To describe the immune responses elicited by prophylactic oral PRAK-03202 vaccine as assessed by IgG titers in healthy volunteers after two doses., Immunogenicity assessments for SARS-CoV-2 IgG, titers from Week 3 through week 24 |
Secondary Outcome, To describe the immune responses elicited by prophylactic oral PRAK-03202 vaccine as assessed by IgG against VLP titers in healthy volunteers after two doses., Exploratory endpoints: IgG against VLP titters, will be assessed from Week 3 through week 24 and will be evaluated descriptively. |
Section Name
|
Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
31/10/2022 |
Justification:
To present the laboratory measurements that may identify SARS CoV2 by the measurements of (as measured by the developed laboratory kit):
• IgG against VLP titers
• IgA against VLP titers
• Specific T-Cells activation |
Secondary Outcome, To describe the immune responses elicited by prophylactic oral PRAK-03202 vaccine as assessed by IgA titers in healthy volunteers after two doses., Immunogenicity assessments for SARS-CoV-2 IgA, titers from Week 3 through week 24 |
Secondary Outcome, To describe the immune responses elicited by prophylactic oral PRAK-03202 vaccine as assessed by IgA against VLP titers in healthy volunteers after two doses. , Immunogenicity assessments for SARS-CoV-2 VLP IgA, titers from Week 3 through week 24 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
31/10/2022 |
Justification:
To present the laboratory measurements that may identify SARS CoV2 by the measurements of (as measured by the developed laboratory kit):
• IgG against VLP titers
• IgA against VLP titers
• Specific T-Cells activation |
Secondary Outcome, To describe the immune responses elicited by prophylactic oral PRAK-03202 vaccine as assessed by IgM titers in healthy volunteers after two doses., Immunogenicity assessments for SARS-CoV-2 IgM titers from week 3 through week 24 |
Secondary Outcome, To describe the cell mediated immune responses elicited by prophylactic oral PRAK-03202 vaccine as assessed by specific T-Cells activation in healthy volunteers after two doses., Assessment of T-Cell activation from week 3 through week 24 |
Section Name
|
Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
31/10/2022 |
Justification: Due to the development of additional laboratory kits that may identify Anti-SARS-CoV-2 neutralizing titers and specific IgG titers. |
|
Secondary Outcome, To describe the immune responses elicited by prophylactic oral PRAK-03202 vaccine as assessed by Anti-SARS-CoV-2 neutralizing titers, Spike1 (S1)-binding IgG titers, Envelope (E)-binding IgG titers, Membrane (M) binding IgG titers in healthy volunteers after two doses., Day 1 through week 24 |
Section Name
|
Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
Recruitment Centre |
RecruitmentCentre List |
31/10/2022 |
Additional site included in the study to enhance recruitment rate. |
|
Newtown Clinical Research Centre, 104 Rahima Moosa Street First Floor Newgate Centre Newtown, Johannesburg, 2001, South Africa |
Section Name
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Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
COMPLETION_STATUS |
08/12/2023 |
Study completed. Close-out visit completed 23 Nov 2023. |
In Progress |
Completed |