This is an interventional study (clinic trial). Phase 2 is Randomized, Double-blind, Multicenter Study to Evaluate the Safety, Reactogenicity, Tolerability, and Immunogenicity of BBV152 in Healthy Volunteers. The clinic trial of phase 1 and 2 were conducted in India. The age is between ≥12 to ≤ 65 years.

Emory University

- BBV152 is an inactivated SARS-CoV-2 vaccine in rhesus macaques. Both Phase 1 and Phase 2 were launched in India. The sponsor is Bharat Biotech International Limited and collaborator is Indian Council of Medical Research.
- Study Description
- Study Design
- Arms and Interventions
- Outcome Measures

BBV152 (Covaxin)

U.S. National Library of Medicine. (2020). Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers (BBV152). Retrieved from https://clinicaltrials.gov/ct2/show/study/NCT04471519

Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers (BBV152)

- Summary: Double blind, Multi-Centre study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of three investigational vaccine groups and one placebo group in healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations and placebo. A total sample size of 755 healthy volunteers, with 375 and 380 volunteers in phase 1 and 2 studies, respectively.

Study Description

Study Design

- Phase 1

1) Experiment: BBV152A or BBV152B or BBV152C. 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14.

2) Control: Placebo: 0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14.

-Phase 2

1) Experiment: BBV152A or BBV152B. 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28. 

Arms and Interventions

The outcome measurements for the Phase 1 and Phase 2 clinical trials of the **BBV152 (Covaxin)** vaccine evaluate patient safety and immune response across two distinct phases.

**Primary Outcome Measurements:**
- **Phase 1:** Occurrence of adverse events and serious adverse events (evaluating safety).
- **Phase 2:** Evaluation of neutralizing antibody titers pre- and post-vaccination (evaluating immune response).

**Secondary Outcome Measurements:**
- **Phase 1:** Evaluation of neutralizing antibody titers pre- and post-vaccination.
- **Phase 2:** Occurrence of adverse events and serious adverse events.

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