1. Safety and Immunogenicity of the H56:IC31 Tuberculosis Vaccine Candidate in Adults Successfully Treated for Drug-Susceptible Pulmonary Tuberculosis: A Phase 1 Randomized Trial.
- Author
-
Tait, Dereck, Diacon, Andreas, Borges, Álvaro H, Brakel, Elana van, Hokey, David, Rutkowski, Kathryn T, Hunt, Devin J, Russell, Marisa, Andersen, Peter L, Kromann, Ingrid, Ruhwald, Morten, Churchyard, Gavin, and Dawson, Rodney
- Subjects
CLINICAL trial registries ,MYCOBACTERIUM tuberculosis ,TUBERCULOSIS vaccines ,TUBERCULOSIS ,IMMUNE response - Abstract
Background H56:IC31 is a candidate vaccine against tuberculosis (TB) with the potential to reduce TB recurrence rate. It is thus important for future clinical trials to demonstrate safety and immunogenicity of H56:IC31 in individuals treated for TB. Methods Twenty-two adults confirmed to be Mycobacterium tuberculosis negative (by 2 GeneXpert tests or 2 sputum cultures) after 4–5 months of TB treatment, and not more than 28 days after completion of TB treatment, were randomized to receive 2 doses of H56:IC31 (5 mg H56:500 nmol IC31; n = 16) or placebo (n = 6) 56 days apart. Participants were followed for 420 days for safety and immunogenicity. Results H56:IC31 vaccination was associated with an acceptable safety profile, consisting mostly of mild self-limited injection site reactions. No serious adverse events or vaccine-related severe adverse events were reported. H56:IC31 induced a CD4
+ T-cell response for Ag85B and ESAT-6, with ESAT-6 being immunodominant, which persisted through 6 months after the last vaccination. There was some evidence of CD8+ T-cell responses for both Ag85B and ESAT-6, but to a lesser extent than CD4+ responses. Conclusions H56:IC31 was associated with an acceptable safety profile, and induced a predominant CD4+ T-cell response, in adults recently treated for drug-susceptible, uncomplicated pulmonary TB. Clinical Trials Registration NCT02375698. [ABSTRACT FROM AUTHOR]- Published
- 2024
- Full Text
- View/download PDF