A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of H56:IC31 in Reducing the rate of TB Disease Recurrence in HIV Negative Adults Successfully Treated for Drug-Susceptible Pulmonary Tuberculosis

Phase 2

• Conditions: Tuberculosis; Respiratory

• Registration Number: PACTR201808711101850
• Lead Sponsor: IAVI South Africa NPC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1.Completed the written informed consent process.
2.Agrees to give access to medical records for study related purposes.
3.HIV-negative (self-reported) with a diagnosis of drug susceptible pulmonary TB at the start of the TB treatment.
4.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).
5.Tested Mtb negative by smear AFB microscopy of 2 separate sputum samples taken on V2. Participants unable to produce sputum, but considered asymptomatic by the investigator, may be considered Mtb negative and eligible for inclusion.
6.Confirmed HIV negative on V2.
7.Completed = 5 months (22 weeks) of TB treatment with treatment still ongoing at the time of the 1st vaccination on V3= Day 0, and total treatment time not extended beyond 28 weeks.
8.Aged = 18 years on the date of V1 and = 60 years on the date of V3= Day 0.
9.Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the area for the duration of the study.

Exclusion Criteria

1.Diagnosis or co-diagnosis of extra pulmonary TB.
2.Hospitalized for the current episode of drug susceptible pulmonary TB disease.
3.History of receipt of treatment against active TB, prior to the current treatment episode, within the last 5 years.
4.History of or ongoing severe disease that in the opinion of the investigator might affect the safety of the participant or the immunogenicity of the investigational product.
5.Insulin dependent diabetes.
6.History of allergic disease or reactions likely to be exacerbated by any component of the investigational product.
7.History or laboratory evidence of immunodeficiency, autoimmune disease or immunosuppression.
8.History of chronic hepatitis.
9.Severe anemia, defined as hemoglobin less than 10 g/dL or a hematocrit less than 30 % based on most recent hematology obtained before randomization.
10.Receipt of any investigational TB vaccine previously.
11.Receipt or planned receipt of any investigational drug or investigational vaccine from V1 through V8= Day 421.
12.Receipt or planned receipt of any licensed vaccine from V1 through V6= Day 70, except for SARS-Cov-2 vaccines recommended by national vaccination programs which will be allowed if given > 28 days before and from the time of administration of clinical trial product.
13.Receipt of treatment likely to modify the immune response (e.g. blood products, immunoglobulins, immunosuppressive treatment) within 42 days before V3= Day 0 through V6= Day 70. Inhaled and topical corticosteroids are permitted.
14.Has a body mass index (BMI) < 13 (weight, kg / height, m2) on the date of V1.
15.Female participants of childbearing potential (not sterilized, menstruating or within 1 year of last menses, if post-menopausal): if not willing to use an acceptable method to avoid pregnancy (sterile sexual partner, sexual abstinence, hormonal contraceptives (oral, injection, transdermal patch, or implant) or intrauterine device from 28 days before V3= Day 0 until 2 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of TB disease recurrence (relapse or reinfection), defined as TB diagnosed by confirmation of Mtb by culture of sputum during the period starting 14 days after the 2nd vaccination (V6= Day 70) and ending 12 months after the 2nd vaccination (V8= Day 421).

Secondary Outcome Measures

Name	Time	Method
•Solicited adverse events and all adverse events occurring the first 14 days after each of the 1st and 2nd vaccinations<br>•Serious adverse events including medically important events occurring after the 1st vaccination through the end of the study<br>