Zambart is one of the study sites for a Phase IIb trial of a new TB vaccine. The trial is being conducted by Aeras and GlaxoSmithKline Vaccines, S.A. (GSK) and is a double-blind randomised, placebo controlled study. (Clinical Trail.gov Identifier: NCT01755598) to evaluate the efficacy, safety and immunogenicity of GSK’s proprietary vaccine candidate M72/AS01E* also known as the TB018. Overall the trial will enroll more than 3500 healthy adults with latent (asymptomatic) TB infection (LTBI) ages 18-50 in TB-endemic sub-Saharan African countries, South Africa, Zambia and Kenya.
GSK’s proprietary vaccine candidate M72/AS01E comprises an immunogenic fusion protein (M72) derived from two M. Tuberculosis antigens (Mtb 32 and Mtb 39), which has been evaluated in animal and human studies overall several years and the AS01E adjuvant system. In early clinical trials, this vaccine had proven effective in mobilizing immune cells believed to play a key role in protection against TB disease, but it is not yet know whether this will confer protection against the disease.
Though the trial began in the other sites in the last quarter of 2015, recruitment from the two sites in Zambia, namely the Zambart site at Kanyama Health Center, and the CIDRZ site of Kalingalinga Health Center, began in June 2015 due to some delays in getting regulatory approval. Out of an expected enrolment projection of 405 from our site, we only enrolled 26 participants by the end of the active recruitment phase of the trial in October 2015 when the overall enrolment target of more than 3500 was reached, in the 3 countries.
The vaccine was administered in a two dose regimen. All participants have received the vaccines and will be followed actively over a 3- year period. There have been no serious adverse events reported from the Zambart site since the study began. Our last participant is expected to be followed-up until February 2019.