Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine: A Phase 3 Randomized Clinical Trial.

ABSTRACT:

Importance

There is a need for improved immunogenicity of hepatitis B virus (HBV) vaccines among young adults with risk of infection.

Objectives

To demonstrate manufacturing equivalence of a 3-antigen (3A) HBV vaccine, evaluate noninferiority of seroprotection rate (SPR) of 3A-HBV vs single-antigen (1A) HBV after 2 and 3 vaccine doses, and compare safety and reactogenicity between 3A-HBV and 1A-HBV vaccines.

Design, setting, and participants

This phase 3, double-blinded, randomized clinical trial included healthy adults aged 18 to 45 years randomized to 1 of three 3A-HBV groups or 1 control group receiving 1A-HBV. The trial was conducted at 37 community clinics and academic hospitals in Canada, Europe, the United Kingdom, and the United States between December 2017 an

SUBMITTER: Vesikari T 

PROVIDER: S-EPMC8511978 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature