None listed
Conditions
Interventions
Intervention1: GEMCOVAC-19: GEMCOVAC-19 will be administered as a 2 dose schedule on Days 1 and 29 as 0.5 mL intramuscularly
Control Intervention1: COVISHIELD (SII-ChAdOx1 nCoV-19): COVISHIELD will be
Sponsors
Gennova Biopharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Only Phase II) Occurrence and severity of local and systemic reactogenicity adverse events, unsolicited events and serious adverse events (SAE) Immunogenicity (Phase II and III) Geometric mean titer (GMT) as measured by IgG-ELISA against SARS-CoV-2 Spike protein. Timepoint: Safety Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. Immunogenicity Immunogenicity at 43 day (14 days post dose 2) for Phase II and III | — |
Secondary
| Measure | Time frame |
|---|---|
| Cellular Immunity (Phase II and III) Cell mediated immunity assessment in terms of cytokine expression Timepoint: Cellular Immunity Day 29, 43 and 119. ;Immunogenicity (Phase II and III) 1. Anti-Spike IgG GMT 2. GMFR in Anti-Spike IgG 3. Proportion of subjects seroconverted in terms of 2-fold rise (inclusive) in anti-spike IgG titer in seropositive subjects and 4-fold rise (inclusive) in anti-spikeTimepoint: 1. Anti-spike IgG GMT at day 29, 119 and 209. 2. GMFR in anti-spike IgG GMT at day 29 and 43. 3. Proportion of subjects seroconverted at day 43. ;Neutralization Phase II - cPASS and PRNT assay Phase III - cPASS, PRNT and pseudovirus assayTimepoint: cPASS on Day 29, 43, 119 and 209 PRNT on day Day 29 and 43 Pseudovirus assay on Day 29, 43 and 119 ;Safety (Phase III) Occurrence and severity of local and systemic reactogenicity adverse events, unsolicited events and serious adverse events (SAE) Timepoint: Safety (Phase III) Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. | — |
Countries
India
Contacts
Public ContactDr Amit Saraf
Gennova Biopharmaceuticals Limited
Outcome results
None listed