An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers

Summary

The BBV152 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of BBV152 to prevent COVID-19 for up to 1 year after the second dose of BBV152.

Conditions

• Covid19
• SARS-CoV Infection

Interventions

BIOLOGICAL

BBV152

BBV152 (6µg-Algel - Imidazoquinoline)

BIOLOGICAL

Placebo

Placebo (PBS+Alum, without antigen)

Sponsors & Collaborators

• Indian Council of Medical Research

  collaborator OTHER_GOV

• Iqvia Pty Ltd

  collaborator INDUSTRY

• Bharat Biotech International Limited

  lead INDUSTRY

Principal Investigators

• Dr Chadramani Singh · All India Institute of Medical Sciences

• Dr Sanjay Kumar Rai · All India Institute of Medical Sciences Delhi

• Dr Azhar Ali Khan · Baba Raghav Das Medical Gorakhpur

• DrAnil Kumar Pandey · ESIC Medical College and Hospital Faridabad

• Dr Simmi Dube · Gandhi Medical College, Bhopal

• Dr Anjan Jyoti Talukdar · Gauhati Medical College & Hospital Assam

• Dr Priti Meshram · Grant Government Medical College and Sir J.J. Group of Hospitals Mumbai

• Dr Laxmi S Kumari · Guntur Medical College ,Guntur

• Dr Shiva Narang · Guru Teg Bahadur Hospital

• Dr E Venkat Rao · Institute of Medical Sciences and SUM Hospital Odisha

• Dr P Venugopal · King George Hospital Visakhapatnam

• Dr. N.T. Awad · Lokamanya tilak Municipal Medical College and General hospital Mumbai

• Dr Pajanivel Ranganadin · Mahatma Gandhi Medical College& Research Institute Pondicherry

• Dr Prabhakar Reddy · Nizam's Institute of Medical Sciences Hyderabad

• Dr Raghavendra Gumashta · Peoples university Bhopal

• Dr Tapan Kumar Saikia · Prince Aly Khan Hospital Mumbai

• Dr Savita Verma · Pt BO Sharma,PGIMS/UHS. Rohtak, Haryana

• Dr Manish Multani · Rahate Surgical Hospital ,Nagpur

• Dr Sagar Vivek Redkar · Redkar Hospital and Research Centre Goa

• Dr Meghana Murthy · Vagus Super speciality hospital,Bangalore

• Dr Akshata · Vydehi Institute of Medical Sciences and Research Centre,Bangalore

• Dr T S Selvavinayagam · Directorate of Public Health and Preventive Medicine,Chennai

• Dr Suman Kanungo · ICMR-National Institute of Cholera and Enteric Diseases,West Bengal

• Dr Mohammad Shameem · Aligarh Muslim University,Uttar Pradesh

• Dr Parul Bhatt · Gmers Medical College and Civil Hospital,Ahmedabad

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-16

Primary Completion

2021-01-08

Completion

2022-12-31

Countries

• India

Study Locations