9 October 2015 SATVI commences with Phase 2a TB vaccine candidate
The South African Tuberculosis Vaccine Initiative (SATVI) has announced the roll out of a Phase 2a trial of the ID 93+GLA-SE tuberculosis (TB) vaccine candidate, which is being conducted in partnership with the Infectious Disease Research Institute (IDRI) and the Welcome Trust. The study will evaluate the safety and immunogenicity of the vaccine in subjects who have recently had TB disease and completed a full course of treatment.
This vaccine has shown promise in treating and preventing TB in animal models in pre-clinical studies and safety has been demonstreated in early human trials. The vaccine will be tested further in Cape Town and Worcester, where SATVI conducts clinical trials to develop a new TB vaccine, in partnership with the Desmond Tutu HIV Foundation, TASK Applied Science, and Stellenbosch University.
A positive result from this trial would allow ID 93+GLA-SE to move into the next (efficacy) phase of clinical development as an adjunctive therapeutic TB vaccine - to test protection against relapse. A course of treatment for TB takes 6 months or more, and much longer in the case of drug-resistant TB. The main reason for such long courses of treatment is the danger of recurrent disease. An effective vaccine that prevents recurrence of TB disease might allow much shorter courses of therapy, alleviating the treatment burden on patients and healthcare systems, which would be a major positive breakthrough for global TB control.