CompletedPhase 2

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

South Africa831 participantsStarted 2019-01-31

Plain-language 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).

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Completed the written informed consent process.
✓. Agrees to give access to medical records for trial related purposes.
✓. Was HIV-negative (self-reported) with a diagnosis of drug susceptible pulmonary TB at the start of the TB treatment.
✓. Able to provide 2 separate sputum samples within ≤ 7 days of starting TB treatment. Participants are not expected to provide sputum samples prior to starting TB treatment if their 1st screening visit (V1) is performed on the same day as their 2nd screening visit (V2).
✓. Confirmed Mtb negative by smear AFB microscopy of 2 separate sputum samples taken at V2. Participants unable to produce sputum, but considered asymptomatic by the investigator, may be considered Mtb negative and eligible for inclusion.
✓. Confirmed HIV negative at V2.
✓. Completed ≥ 5 months (22 weeks) of TB treatment with treatment still ongoing at the time of the 1st vaccination and total treatment time not extended beyond 28 weeks.
✓. Aged ≥ 18 years on the date of V1 and ≤ 60 years on the date of V3= Day 0.

Exclusion criteria

What they're measuring

Rate of TB Disease Recurrence (Relapse or Reinfection), Defined as TB Diagnosed by Confirmation of Mtb by Culture of Sputum.

Timeframe: During the period starting 14 days after the 2nd vaccination (V6= Day 70) and ending 12 months after the 2nd vaccination

Trial details

NCT IDNCT03512249

SponsorInternational AIDS Vaccine Initiative

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2023-03-20

Results submitted2024-07-17

View on ClinicalTrials.gov More Tuberculosis, Pulmonary trials