Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol

Summary

This is a phase 1 study, in healthy volunteers who have previously been immunized with bacilli Calmette Guerin (BCG), to evaluate the safety and immune responses that develop in the blood and lungs following the administration by aerosol of a new experimental adenovirus-based vaccine for tuberculosis (TB), Ad5Ag85A.

Timeline

Start

2017-09-05

Primary completion

2021-09-07

Completion

2021-09-07

Publications

• Jeyanathan M, Fritz DK, Afkhami S, Aguirre E, Howie KJ, Zganiacz A, Dvorkin-Gheva A, Thompson MR, Silver RF, Cusack RP, Lichty BD, O'Byrne PM, Kolb M, Medina MFC, Dolovich MB, Satia I, Gauvreau GM, Xing Z, Smaill F. Aerosol delivery, but not intramuscular injection, of adenovirus-vectored tuberculosis vaccine induces respiratory-mucosal immunity in humans. JCI Insight. 2022 Feb 8;7(3):e155655. doi: 10.1172/jci.insight.155655.

Drugs

Indications