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

Phase 1

Completed

• Conditions: SARS-CoV-2 Infection; COVID-19
• Interventions: Biological: BBV152B - Phase II; Biological: BBV152A - Phase I; Biological: BBV152B - Phase I; Biological: BBV152A - Phase II; Biological: BBV152C - Phase I; Biological: Placebo - Phase I

• 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.

Study Timeline

• Study First Submitted: 2020-07-11
• Study First Submitted QC: 2020-07-14
• Study Start: 2020-07-15
• Study First Posted: 2020-07-15
• Primary Completion: 2020-07-31
• Study Completion: 2021-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 755

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BBV152B - Phase II	BBV152B - Phase II	0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine \[BBV152B\], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 28
BBV152A - Phase I	BBV152A - Phase I	0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine \[BBV152A\], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14
BBV152B - Phase I	BBV152B - Phase I	0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine \[BBV152B\], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14
BBV152A - Phase II	BBV152A - Phase II	0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine \[BBV152A\], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 28.
BBV152C - Phase I	BBV152C - Phase I	0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine \[BBV152C\], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14
Placebo - Phase I	Placebo - Phase I	0.5 mL of Placebo will be administered intramuscularly twice at Day 0 and Day 14.

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)

All India Institute of Medical Sciences; 🇮🇳 Delhi, New Delhi, India

Rana Hospital and Trauma Center; 🇮🇳 Gorakhpur, Uttar Pradesh, India

Jeevan Rekha Hospital; 🇮🇳 Belgaum, Karnataka, India

Gillukar Multispeciality Hospital; 🇮🇳 Nagpur, Maharastra, India

King George Hospital; 🇮🇳 Visakhapatnam, Andhra Pradesh, India

Redkar Hospital and Research Centre; 🇮🇳 Goa, India

Pt BD SHARMA,PGIMS/UHS; 🇮🇳 Rohtak, Haryana, India

Nizam's Institute of Medical Sciences; 🇮🇳 Hyderabad, Telangana, India

Prakhar Hospital; 🇮🇳 Kanpur, Uttar Pradesh, India

Institute of Medical Sciences and SUM Hospital; 🇮🇳 Bhubaneswar, Orissa, India

SRM Hospital & Research center; 🇮🇳 Chennai, Tamilnadu, India