Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
1125

Summary

Conditions
  • COVID-19
  • SARS CoV-2 Infection
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 12 years and 65 years
Gender
Both males and females

Description

Phase 1 study The study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Four arms of healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations or Placebo. A total no of 375 subjects will be enrolled in 4:1 ratio. This study will be ...

Phase 1 study The study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Four arms of healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations or Placebo. A total no of 375 subjects will be enrolled in 4:1 ratio. This study will be conducted in a dose escalatory manner with a two-dose regimen fourteen days apart. Phase 2 study The study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of two arms of healthy volunteers who will receive two intramuscular doses of BBV152 vaccine formulations (BBV152-A & BBV152-B) in a 1:1 ratio with dosage schedule on Day 0 and Day 28. 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. The investigator, participant and Sponsor were blinded to the allocation.

Tracking Information

NCT #
NCT04471519
Collaborators
Indian Council of Medical Research
Investigators
Principal Investigator: Dr. Savita Verma, MBBS, MD PGIMS, Rohtak Principal Investigator: Dr. Sanjay Kumar Rai, MBBS, MD All India Institute of Medical Sciences, Delhi Principal Investigator: Dr. Chandramani Singh, MBBS, MD All India Institute of Medical Sciences, Patna Principal Investigator: Dr. Ajeeth Pratap Singh, MBBS, MD Rana Hospital and Trauma Centre, Gorakhpur Principal Investigator: Dr. Satyajit Mohapatra, MBBS, MD SRM Hospital and Research Centre, Chennai Principal Investigator: Dr. Prabhakar Reddy, MBBS, MD Nizams Institute of Medical Sciences, Hyderabad Principal Investigator: Dr. Venkata Rao, MBBS, MD IMS & SUM Hospital, Orissa Principal Investigator: Dr. Jitendra Kushwaha, MBBS, MD Prakhar Hospital, Kanpur Principal Investigator: Dr. Sagar Vivek Redkar, MBBS, MD Redkar Hospital and Research Center, Goa Principal Investigator: Dr. Amit Bhate, MBBS, MD Jeevan Rekha Hospital, Belguam Principal Investigator: Dr. Chadrashekar Gillukar, MBBS, MD Gillukar Multispeciality Hospital, Nagpur Principal Investigator: Dr Vasudev R, MBBS, MD King George Hospital