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Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants

COVID-19 Clinical Trial

Official title:
A Phase II Trial to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Monovalent and Multivalent RNA-based Vaccines in Healthy Subjects

Clinical Trial Summary

This trial consists of three parts, Part A, Part B, and Part C, and will evaluate the safety and immunogenicity of a third booster injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who have received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the second dose of BNT162b2. It will also evaluate the safety and immunogenicity of a three-dose regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who have not received prior Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity of BNT162b2 (B.1.1.529.1) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19 vaccine-experienced participants with history of SARS-CoV-2 infection will be evaluated and contrasted with the natural immune response reached after infection with the SARS-CoV-2 Omicron variant.

Clinical Trial Description

Trial participants in Part A will be assigned to one of 6 cohorts (Cohort 1-6). Trial participants in Part B will be assigned to one of 3 cohorts (Cohort 1, 4, and 6). Trial participants in Part C will be randomized in a 2:2:1 ratio into 3 cohorts (Cohort 7-9). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05004181
Study type Interventional
Source BioNTech SE
Contact
Status Completed
Phase Phase 2
Start date August 25, 2021
Completion date October 4, 2023
View Details
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