Tuberculosis vaccine trials

Abstract

We read with interest your news report of a new tuberculosis vaccine trial in South Africa, 1 Bosch X Tuberculosis vaccine trial gets underway. Lancet Infect Dis. 2004; 4: 598 Summary Full Text Full Text PDF PubMed Google Scholar and are pleased to learn that the phase I rBCG30 trial will begin shortly. This trial will be at least the third—not the first—human trial of a new tuberculosis vaccine to be conducted in Africa. Several phase I trials and two phase II trials (one in Finland, 2 Vuola J Ristola M Cole B et al. Immunogenicity of an inactivated mycobacterial vaccine for the prevention of HIV-associated tuberculosis: a randomized, controlled trial. AIDS. 2003; 17: 2351-2355 Crossref PubMed Scopus (51) Google Scholar one in Zambia 3 Waddell RD Chintu C Lein AD et al. Safety and immunogenicity of a five-dose series of inactivated Mycobacterium vaccae vaccine for the prevention of HIV associated tuberculosis. Clin Infect Dis. 2000; 30: S309-S315 Crossref PubMed Scopus (53) Google Scholar ) demonstrated that a new inactivated, whole-cell mycobacterial vaccine was safe and immunogenic in patients with HIV infection, and boosted BCG-primed responses to mycobacterial antigens. A phase III efficacy trial of this new vaccine, sponsored by the National Institutes of Health, was initiated in 2001 in Tanzania (DARDAR Health Study). The study is based on a prime-boost immunisation strategy in which BCG-positive participants are given a multiple-dose series of the new inactivated tuberculosis vaccine or placebo, and are followed for the development of tuberculosis. 4 Vuola J, Cole B, Matee M, et al. Baseline mycobacterial immunity in HIV-positive adults entering the DARDAR TB booster vaccine trial in Tanzania. 42nd annual meeting of the Infectious Disease Society of America; 2004; Boston, MA. Abstract 882. Google Scholar Another study of a new tuberculosis vaccine has just been completed in The Gambia. In this phase I study, tuberculin-negative Gambian subjects were immunised with a recombinant-modified vaccinia virus Ankara vaccine expressing antigen 85 (MVA85A); the vaccine was both safe and immunogenic. 5 Ibanga HB, Hill PC, Owiafe PK, McShane H, Hill AV, Brookes R. Screening, safety and immunogenicity of modified vaccinia virus Ankara vaccine against tuberculosis in Africa: results from the Gambia. 42nd annual meeting of the Infectious Disease Society of America; 2004; Boston, MA. Abstract 588. Google Scholar