Safety and immunogenicity study of an mRNA based vaccine GEMCOVAC-19 for COVID19 in healthy adult participants.
- Registration Number
- CTRI/2021/09/036379
- Lead Sponsor
- Gennova Biopharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4405
1. Male and female subjects’ 18- 80 years (both inclusive) for Phase II and > 18 (inclusive) years for Phase III. 2.Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator. 3. Subject should be capable and willing to give voluntary written informed consent prior to inclusion in the study. 4. Subject is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. 5. Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2. 6. Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child bearing potential should be willing to follow effective birth control methods for duration of the study.
1. Subject with a recent history of COVID-19 infection within 3 months from Screening.
2. Subjects received an investigational vaccine or vaccine which have been granted an emergency use to prevent COVID-19 infection.
3. Any clinically significant laboratory values (Only Phase II).
4. Any significant illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.
5. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
6. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature > 38°C or > 100.4 °F (inclusive) or its equivalent for axillary and tympanic) within 48 hours prior to vaccination.
7. History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease.
8. Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study.
9. Prior major surgery or any radiation therapy within 4 weeks of Screening visit.
10. Positive serologic test for HIV 1 and 2, HBsAg or HCV.
11. Current (within 14 days prior to Screening visit) or anticipated concomitant immune-modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).
12. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.
13. Eczema or other significant skin lesion or infection at the site of vaccination.
14. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit.
15. Bleeding diathesis or condition associated with prolonged bleeding.
16. Subjects with a history of thromboembolic events.
17. History of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome
18. Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate.
19. Any other condition which in the opinion of the Investigator may affect subject’s safety or participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (Only Phase II) <br/ ><br>Occurrence and severity of local and systemic reactogenicity adverse events, unsolicited events and serious adverse events (SAE) <br/ ><br> <br/ ><br>Immunogenicity (Phase II and III) <br/ ><br>Geometric mean titer (GMT) as measured by IgG-ELISA against SARS-CoV-2 Spike protein. <br/ ><br>Timepoint: Safety <br/ ><br>Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. <br/ ><br> <br/ ><br>Immunogenicity <br/ ><br>Immunogenicity at 43 day (14 days post dose 2) for Phase II and III <br/ ><br>
- Secondary Outcome Measures
Name Time Method