Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers
- Conditions
- SARS-CoV-2 InfectionCOVID-19
- Registration Number
- NCT04471519
- Lead Sponsor
- Bharat Biotech International Limited
- Brief 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.
- Detailed 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 755
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Phase 1: Occurrence of adverse events and Serious Adverse events Through study completion, an average of 6 months Safety
Phase 2: Evaluation of Neutralizing Antibody Titers Through study completion, an average of 6 months Pre- and Post-vaccination immune response
- Secondary Outcome Measures
Name Time Method Phase 2: Evaluation of Neutralizing Antibody Titers Through study completion, an average of 6 months Post-vaccination immune responses comparing two-dose and three dose regimens
Phase 2: Occurrence of adverse events and Serious Adverse events Through study completion, an average of 6 months Safety
Phase 1: Evaluation of Neutralizing Antibody Titers Through study completion, an average of 6 months Pre- and Post-vaccination immune response
Trial Locations
- Locations (11)
King George Hospital
🇮🇳Visakhapatnam, Andhra Pradesh, India
All India Institute of Medical Sciences
🇮🇳Delhi, New Delhi, India
Pt BD SHARMA,PGIMS/UHS
🇮🇳Rohtak, Haryana, India
Jeevan Rekha Hospital
🇮🇳Belgaum, Karnataka, India
Gillukar Multispeciality Hospital
🇮🇳Nagpur, Maharastra, India
Institute of Medical Sciences and SUM Hospital
🇮🇳Bhubaneswar, Orissa, India
SRM Hospital & Research center
🇮🇳Chennai, Tamilnadu, India
Nizam's Institute of Medical Sciences
🇮🇳Hyderabad, Telangana, India
Rana Hospital and Trauma Center
🇮🇳Gorakhpur, Uttar Pradesh, India
Prakhar Hospital
🇮🇳Kanpur, Uttar Pradesh, India
Scroll for more (1 remaining)King George Hospital🇮🇳Visakhapatnam, Andhra Pradesh, India