Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination.

ABSTRACT:

Background

Recent Mycobacterium tuberculosis infection confers a predisposition to the development of tuberculosis disease, the leading killer among global infectious diseases. H4:IC31, a candidate subunit vaccine, has shown protection against tuberculosis disease in preclinical models, and observational studies have indicated that primary bacille Calmette-Guérin (BCG) vaccination may offer partial protection against infection.

Methods

In this phase 2 trial, we randomly assigned 990 adolescents in a high-risk setting who had undergone neonatal BCG vaccination to receive the H4:IC31 vaccine, BCG revaccination, or placebo. All the participants had negative results on testing for M. tuberculosis infection on the QuantiFERON-TB Gold In-tube assay (QFT) and for the human immunode

SUBMITTER: Nemes E 

PROVIDER: S-EPMC5937161 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature