5 August 2015 Research Update
In the period June to July 2015 researchers with the South African Tuberculosis Vaccine Initiative have published new research findings of four (4) phase I/IIa trials of different TB vaccine candidates, contributing to the body of knowledge shaping the development of a new vaccine to eradicate tuberculosis. The papers, all published in the Journal Vaccine, report the safety results and reactogenicity to vaccination and immune responses induced by the following TB vaccine candidates:
- Aeras402 (Adenovirus35 viral vector vaccine expressing Ag85A, Ag85B and TB10.4, manufactured by Crucell)
TITLE: “A double-blind, randomised, placebo-controlled, dose-finding trial of the novel tuberculosis vaccine AERAS-402, an adenovirus-vectored fusion protein, in healthy, BCG-vaccinated infants” by Michele Tameris, David Hokey (Aeras) and co-authors. This dose-finding study in infants found that all three doses had an acceptable safety profile and that the vaccine was immunogenic, although the induced immune response was considerably lower than that previously observed in adults.
- M72 (Mtb32 and Mtb39 polyprotein subunit vaccine formulated in ASO1E adjuvant, GSK)
TITLE: “Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting”, by Adam Penn-Nicholson, Hennie Geldenhuys and co-authors. The study found that M72/AS01E had a clinically acceptable safety and immunogenicity profile in both uninfected or Mtb-infected adolescents from South Africa, and support efficacy trials of the M72/AS01E vaccine.
- H4:IC31 (Ag85B and ESAT-6 polyprotein subunit vaccine formulated in IC31 adjuvant, Sanofi Pasteur)
TITLE: “The tuberculosis vaccine H4:IC31 is safe and induces a persistent polyfunctional CD4 T cell response in South African adults: A randomized controlled trial” by Hennie Geldenhuys, Helen Mearns and co-authors. This phase I trial showed that the H4:IC31 vaccine demonstrated an acceptable safety profile and was immunogenic in Mtb-infected South African adults. The 15μg dose appeared to induce the most optimal immune response.
- H56:IC31 (Ag85B, ESAT-6 and RV2660c polyprotein subunit vaccine formulated in IC31 adjuvant, Statens Serum Institut).
TITLE: “First-in-human trial of the post-exposure tuberculosis vaccine H56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults” by Angelique Luabeya, Benjamin Kagina and co-authors. This phase I trial demonstrated that the H56:IC31 vaccine demonstrated acceptable tolerability and was immunogenic in uninfected or Mtb-infected South African adults. The 15μg dose appeared to induce the most optimal immune response.