None listed
Conditions
Interventions
Intervention1: GEMCOVAC-OM (COVID-19 BOOSTER vaccine): Dose:0.1mL
Frequency: 1 Dose on Day 1
Administration:
Intradermal
Duration of the study: 6 Months
Control Intervention1: COVISHIELD™ (manufacture
Sponsors
Gennova Biopharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female aged greater than or equal to 18 years 2. Subject who had received primary vaccination (both doses completed) with either a. COVAXIN™ OR b. COVISHIELD™ Wherein last dose of primary vaccination taken at least 4 months prior to the screening visit 3. Subject or their legally acceptable representative (LAR) should be capable and willing to give voluntary written informed consent prior to inclusion in the study 4. Inclusion of subjects based on clinical judgment by the investigator 5. Subjects who had COVID-19 infection after primary vaccination, should have been asymptomatic or RT-PCR negative for at least 3 months 6. Consent for using effective methods of contraception during the entire study period 7. No medical history of pronounced vaccine-induced reactions or complications after receiving immunobiological products 8. No acute infectious and/or respiratory diseases within 14 days prior to screening 9. Subjects able to comprehend and comply with study requirements and procedures and willing to complete subject diary
Exclusion criteria
Exclusion criteria: 1. Prior receipt of any COVID-19 vaccine in less than 4 months of duration 2. Pregnant or lactating mothers 3. 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, haematological 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. 4. History of chronic infections in immunocompromised subjects 5. History of chronic immune disease, Splenectomy or systemic collagenosis 6. Subjects with oncological disease within 5 years prior to inclusion into the study 7. History of the human immunodeficiency virus, syphilis, hepatitis B, or C 8. Acute Kidney injury or dialysis, had transplant and on immunosuppressive therapy 9. Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements 10. Receipt of steroids and/or immunoglobulins or other blood products within 30 days prior to randomization 11. Tattoos or scars at the injection site, which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration 12. Participation in other interventional clinical trial within the previous 90 days prior to randomization and over duration of the trial 13. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II Immunogenicity: Comparison of anti-Spike IgG Antibodies Safety: Occurrence and severity of local and systemic reactogenicity AE Occurrence of unsolicited AE Occurrence of related unsolicited related AE Occurrence of SAE Phase III Immunogenicity: Comparison of neutralizing antibody titers against SARS-CoV-2 using PRNT assay by non-inferiority Comparison of seroconversion rates as assessed by greater than or equal to 2-fold rise in neutralizing antibodies using PRNT assay Timepoint: Phase II Immunogenicity: Day 29 Safety: Day 7 (Local and Systemic reactogenicity) Day 29 (Unsolicited AE) Day 180 (SAE and related unsolicited AE throughout the duration of the study) Phase III Immunogenicity: Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II Immunogenicity: Comparison of seroconversion rates as assessed by more than or equal to 2- fold rise in antibody titers Comparison of neutralizing antibodies against SARS-CoV-2 using a surrogate virus assay (cPASS™) Cell mediated immunity assessment by cytokine expression from stimulated PBMCs Timepoint: Immunogenicity: Day 29 ;Phase III Immunogenicity: Comparison of anti-Spike IgG antibodies (GMT) by non-inferiority Comparison of seroconversion rates as assessed by greater than or equal to 2- fold rise in IgG antibody titers by non-inferiority Comparison of neutralizing antibodies against SARS-CoV-2 using a surrogate virus assay (cPASS) Assessment of cellular immune responses from stimulated PBMCs Safety: Occurrence and severity of local and systemic reactogenicity AEs Occurrence of unsolicited AE Occurrence of related unsolicited AE Occurrence of SAEs Timepoint: Immunogenicity: Day 29 Safety: Day 7 (Local and Systemic reactogenicity) Day 29 (Unsolicited AE) Day 180 (SAE and related unsolicited AE throughout the duration of the study) | — |
Countries
India
Contacts
Public ContactDr Amit Saraf
Gennova Biopharmaceuticals Ltd
Outcome results
None listed