Safety, Immunogenicity, and Impact of MVA85A, on the Immunogenicity of the EPI Vaccines

Summary

This study is preliminary to proving that this vaccine could protect against tuberculosis in humans. Although there is no proven data to show that infants will benefit directly from participation in this study by being protected against TB, MVA85A protection of mice, guinea pigs and monkeys against tuberculosis is encouraging. It is hoped that the information gained from this study will contribute to the development of a safe and effective TB vaccine for HIV negative and positive individuals. Participants in this study will benefit by having information about their general health status, and the rigorous follow up visit that could enhance early detection and management of medical conditions that might arise in the course of the study.

Timeline

Start

2006-10

Primary completion

2009-12

Completion

2009-12

Publications

• Background McShane H, Pathan AA, Sander CR, Keating SM, Gilbert SC, Huygen K, Fletcher HA, Hill AV. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med. 2004 Nov;10(11):1240-4. doi: 10.1038/nm1128. Epub 2004 Oct 24.
• Background Goonetilleke NP, McShane H, Hannan CM, Anderson RJ, Brookes RH, Hill AV. Enhanced immunogenicity and protective efficacy against Mycobacterium tuberculosis of bacille Calmette-Guerin vaccine using mucosal administration and boosting with a recombinant modified vaccinia virus Ankara. J Immunol. 2003 Aug 1;171(3):1602-9. doi: 10.4049/jimmunol.171.3.1602.
• Background Bejon P, Peshu N, Gilbert SC, Lowe BS, Molyneux CS, Forsdyke J, Lang T, Hill AV, Marsh K. Safety profile of the viral vectors of attenuated fowlpox strain FP9 and modified vaccinia virus Ankara recombinant for either of 2 preerythrocytic malaria antigens, ME-TRAP or the circumsporozoite protein, in children and adults in Kenya. Clin Infect Dis. 2006 Apr 15;42(8):1102-10. doi: 10.1086/501459. Epub 2006 Mar 14.
• Background Huygen K, Content J, Denis O, Montgomery DL, Yawman AM, Deck RR, DeWitt CM, Orme IM, Baldwin S, D'Souza C, Drowart A, Lozes E, Vandenbussche P, Van Vooren JP, Liu MA, Ulmer JB. Immunogenicity and protective efficacy of a tuberculosis DNA vaccine. Nat Med. 1996 Aug;2(8):893-8. doi: 10.1038/nm0896-893.

Drugs

Indications