Safety, Tolerability and Immunogenicity of GEMCOVAC-OM as a booster in Subjects 18 years of age and older
- Registration Number
- CTRI/2022/10/046475
- Lead Sponsor
- Gennova Biopharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3280
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase II <br/ ><br>Immunogenicity: <br/ ><br>Comparison of anti-Spike IgG Antibodies <br/ ><br>Safety: <br/ ><br>Occurrence and severity of local and systemic reactogenicity AE <br/ ><br>Occurrence of unsolicited AE <br/ ><br>Occurrence of related unsolicited related AE <br/ ><br>Occurrence of SAE <br/ ><br> <br/ ><br>Phase III <br/ ><br>Immunogenicity: <br/ ><br>Comparison of neutralizing antibody titers against SARS-CoV-2 using PRNT assay by non-inferiority <br/ ><br>Comparison of seroconversion rates as assessed by greater than or equal to 2-fold rise in neutralizing antibodies using PRNT assay <br/ ><br>Timepoint: Phase II <br/ ><br>Immunogenicity: Day 29 <br/ ><br> <br/ ><br>Safety: <br/ ><br>Day 7 (Local and Systemic reactogenicity) <br/ ><br>Day 29 (Unsolicited AE) <br/ ><br>Day 180 (SAE and related unsolicited AE throughout the duration of the study) <br/ ><br> <br/ ><br> <br/ ><br>Phase III <br/ ><br>Immunogenicity: Day 29
- Secondary Outcome Measures
Name Time Method