Prospective, multi-center, randomized, open label, active controlled, seamless phase 2/phase3 clinical study to evaluate immunogenicity, safety and tolerability of RelCoVax® (Protein Subunit Vaccine of Reliance Life Sciences Pvt Ltd. against SARS-CoV-2 Virus) and Corbevax® (Protein Subunit Vaccine of Biological E Ltd. against SARS-CoV-2 Virus) administered as primary vaccination.
- Conditions
- SARS-CoV-2
- Registration Number
- PACTR202307772264605
- Lead Sponsor
- RELIANCE LIFE SCIENCE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1550
Male and female subjects in age group =18 years to = 80 years.
The subjects voluntarily agreed to participate in the study, and signed an informed consent form. Agree to remain in study area for period of study and willing to comply with other protocol requirements.
Subject of stable health as determined by investigator based on medical history, physical examination and laboratory examination at screening.
Axillary Body temperature of between 35.5ºC to 37.2ºC or equivalent depending on location of temperature taking.
Body mass index (BMI) at 18.0 to 35.0 kg/m2 (inclusive).
Willing to allow storage and future use of biological samples for future research
Male and Female subjects of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication.
History of any of the following:
• Any investigational vaccine or a COVID-19 vaccine that has got emergency use authorization or
• Any product (investigational or off-label) for prevention of COVID-19 disease
• Inoculated with any subunit vaccine and inactivated vaccine within 14 days before the first dose of study vaccination,
• Inoculated with live attenuated vaccine within 30 days. • Received influenza vaccination within 14 days prior to first study vaccination
Have an acute illness or acute exacerbation of a chronic illness, as determined by the site Principal Investigator (PI) or sub-investigator, within 72 hours prior to study vaccination which is likely to impact interpretation of study results.
Seropositive for HIV 1 and 2, HBsAg and HCV
Have a history of severe allergies to any component of the research vaccine i.e. RLS Protein Subunit Vaccine against SARS-CoV-2 Virus, including aluminium preparations, such as: anaphylactic shock, allergic laryngeal oedema, allergic purpura, thrombocytopenic purpura, local
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage Seroconversion at day 56 w.r.t. neutralizing antibody against SARS-CoV-2.<br>Note: Seroconversion is defined as = 2 fold rise in neutralizing antibody against SARS-CoV-2 compared to baseline titres. (neutralization will be evaluated in assay using SARS-CoV-2 virus wild strain)
- Secondary Outcome Measures
Name Time Method Percentage Seroconversion, Geometric Mean Titres (GMT), Geometric Mean Titre Ratio (GMTR), Geometric Mean Fold Ratio (GMFR) of neutralizing antibodies at day 0, day 28 and day 56 as assessed by PRNT /Microneutralization Tests / Pseudo Neutralization test. Neutralization against two strains (wild strain and additional variant of concern) will be evaluated.Percentage Seroconversion, Geometric Mean Titres (GMT), Geometric Mean Titre Ratio (GMTR), Geometric Mean Fold Ratio (GMFR) of neutralizing antibodies at day 0, day 28, day 56, day 90 and day 180 as assessed by PRNT /Microneutralization Tests / Pseudo Neutralization test. Neutralization against two strains (wild strain and additional variant of concern) will be evaluated