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

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.

A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or placebo.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

BIOLOGICAL

BBV152A - Phase I

0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14

BIOLOGICAL

BBV152B - Phase I

0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14

BIOLOGICAL

BBV152C - Phase I

0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14

BIOLOGICAL

Placebo - Phase I

0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14

BIOLOGICAL

BBV152A - Phase II

0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28

BIOLOGICAL

BBV152B - Phase II

0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28

Sponsors & Collaborators

• Indian Council of Medical Research

  collaborator OTHER_GOV

• Bharat Biotech International Limited

  lead INDUSTRY

Principal Investigators

• Dr. Savita Verma, MBBS, MD · PGIMS, Rohtak

• Dr. Sanjay Kumar Rai, MBBS, MD · All India Institute of Medical Sciences, Delhi

• Dr. Chandramani Singh, MBBS, MD · All India Institute of Medical Sciences

• Dr. Ajeeth Pratap Singh, MBBS, MD · Rana Hospital and Trauma Centre, Gorakhpur

• Dr. Satyajit Mohapatra, MBBS, MD · SRM Hospital and Research Centre, Chennai

• Dr. Prabhakar Reddy, MBBS, MD · Nizams Institute of Medical Sciences, Hyderabad

• Dr. Venkata Rao, MBBS, MD · IMS & SUM Hospital, Orissa

• Dr. Jitendra Kushwaha, MBBS, MD · Prakhar Hospital, Kanpur

• Dr. Sagar Vivek Redkar, MBBS, MD · Redkar Hospital and Research Center, Goa

• Dr. Amit Bhate, MBBS, MD · Jeevan Rekha Hospital, Belguam

• Dr. Chadrashekar Gillukar, MBBS, MD · Gillukar Multispeciality Hospital, Nagpur

• Dr Vasudev R, MBBS, MD · King George Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-15

Primary Completion

2020-07-31

Completion

2021-06-30

Countries

• India

Study Locations