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BBV152/BBV154 Heterologus Prime-Boost Study

NCT05639998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2022-12-07

No results posted yet for this study

Summary

All participants will be assessed for immunogenicity and safety endpoints and provide a blood sample before the administration of the first dose of IP. Blood samples will be collected on days 0, 9 (Groups 1, 3 and 4), 28,37 (Groups 2 and 4), 56, 90 and 180 to assess the neutralizing antibody titer against the SARSCoV-2 virus. A subset of 160 Participants (40 participants from each group) will be assessed for immunogenicity analysis, among these subset 10mL of blood and 5mL of saliva will be collected on days 0, 9 (Groups 1, 3 and 4), 28, 37 (Groups 2 and 4), 56, 90 and 180 to assess cell-mediated immunity and mucosal immunogenicity.

Group 1 (COVAXIN® + COVAXIN®): In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the intramuscular route.

Group 2 (COVAXIN® + BBV154): In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28.

\*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® viaintramuscular route.

Group 3 (BBV154 + COVAXIN®): In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28.

\*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route.

Group 4 (BBV154 + BBV154): In this group, 152 participants will be recruited who will receive BBV154 on day 0 and on day 28 via the intranasal route.

Conditions

  • Corona Virus Infection

Interventions

BIOLOGICAL

COVAXIN(BBV152)

COVAXIN® on day 0 and on day 28 via the intramuscular route in GROUP 1. COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28:GROUP 2

BIOLOGICAL

BBV154 Intranasal Vaccine

BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28: GROUP 3 BBV154 on day 0 and on day 28 via the intranasal route: GROUP 4

Sponsors & Collaborators

  • Bharat Biotech International Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-03-01
Completion
2022-07-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639998 on ClinicalTrials.gov