drugset / Trial / NCT03512249

Study to Evaluate H56:IC31 in Preventing Rate of TB Recurrence

Phase 2 Completed 831 enrolled International AIDS Vaccine Initiative European and Developing Countries Clinical Trials Partnership (EDCTP) · collab National Institute for Medical Research, Tanzania · collab Ospedale San Raffaele · collab South African Tuberculosis Vaccine Initiative · collab Statens Serum Institut · collab TASK Applied Science · collab The Aurum Institute NPC · collab University of Cape Town Lung Institute · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

This is a phase 2, double-blind, randomized (1:1), placebo-controlled trial with two parallel groups. * H56:IC31 (investigational vaccine) * Placebo 900 HIV-negative adults with a diagnosis of drug susceptible pulmonary TB are planned to be included, recruited from TB clinics with established relationships to the trial sites at the start of their TB treatment. 5 study sites in South Africa: 2 sites from the AURUM institute (Klerksdorp and Tembisa) and 3 in Cape Town at TASK Applied Science (TASK), the University of Cape Town Lung Institute (UCTLI) and South African Tuberculosis Vaccine Initiative (SATVI) under UCT, respectively. 1 study site in Tanzania (TZ): 1 site at Mbeya Medical Research Centre (MMRC) under the National Institute for Medical Research (NIMR).

Timeline

Start: 2019-01-31
Primary completion: 2023-03-20
Completion: 2023-03-20

Outcome

Missed primary endpoint

registry analysis (superiority test); H56:IC31 vs Placebo; p = 0.9558; Log Rank; NCT03512249 ↗

paper Vaccination with H56:IC31 at treatment completion for pulmonary tuberculosis did not reduce the risk of recurrent disease. PMID 40056922 ↗

Publications

Results Borges AH, Russell M, Tait D, Scriba TJ, Nemes E, Skallerup P, van Brakel E, Cabibbe AM, Cirillo DM, Leuvennink-Steyn M, Rutkowski KT, Wood GK, Thierry-Carstensen B, Tingskov PN, Meldgaard EC, Kristiansen MP, Sondergaard RE, Hansen CH, Follmann F, Jensen CG, Gela A, Ntinginya NE, Ruhwald M, Shenje J, White L, Innes C, Selepe P, Ngaraguza B, Holmgren C, Collings T, Andersen P, Dawson R, Churchyard G, Sabi I, Diacon AH, Mortensen R, Hatherill M; POR TB study group. Immunogenicity, safety, and efficacy of the vaccine H56:IC31 in reducing the rate of tuberculosis disease recurrence in HIV-negative adults successfully treated for drug-susceptible pulmonary tuberculosis: a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Infect Dis. 2025 Jul;25(7):751-763. doi: 10.1016/S1473-3099(24)00814-4. Epub 2025 Mar 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	H56:IC31	Vaccine	5 ug	Intramuscular