NCT04471519

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

An Adaptive Phase 1, Followed by Phase 2 Randomized, Double-blind, Multicenter Study to Evaluate the Safety, Reactogenicity, Tolerability, and Immunogenicity of BBV152 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 755 (actual)
• Sponsor: Bharat Biotech International Limited · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-15
• Primary completion: 2020-07-31
• Completion: 2021-06-30
• First posted: 2020-07-15
• Last updated: 2022-08-18

Locations

12 sites across 1 country: India