Actively Recruiting
Evaluating the Safety and Immunogenicity of MTBVAC
Led by HIV Vaccine Trials Network · Updated on 2026-03-12
276
Participants Needed
16
Research Sites
165 weeks
Total Duration
On this page
Sponsors
H
HIV Vaccine Trials Network
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa
CONDITIONS
Official Title
Evaluating the Safety and Immunogenicity of MTBVAC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 12 through 55 years on the day of enrollment
- Access to a participating HVTN or ACTG clinic site and willingness to be followed for the study duration
- Ability and willingness to provide informed consent (or assent with parental/legal guardian consent if under 18)
- Demonstration of understanding of the study through a questionnaire before vaccination
- Prior receipt of BCG vaccine in infancy
- Agreement not to enroll in another investigational study product trial until after study completion
- Good general health as determined by medical history, physical exam, and screening labs
- Willingness to receive HIV test results
- For volunteers without HIV: negative HIV test, assessed low risk for HIV acquisition, and willingness to receive HIV risk counseling
- For volunteers with HIV: completed tuberculosis preventive treatment, documented viral suppression for at least 3 months, and at least 6 months of ART treatment
- For HIV Cohort 2: WHO clinical stage 1 or 2 prior to ART initiation and CD4 count ≥ 200 cells/mm3
- For HIV Cohort 3: advanced HIV disease defined by CD4 count < 200 cells/mm3 or WHO stage 3 or 4, with current CD4 count ≥ 100 cells/mm3
- Normal or grade 1 lab results for hemoglobin, white blood cell count, platelet count, creatinine, ALT, and AST at screening
- Negative Hepatitis B surface antigen and negative Hepatitis C antibody or nucleic acid test
- For females or intersex persons of pregnancy potential: negative pregnancy tests at screening and before vaccination
- Agreement to use effective contraception and avoid pregnancy through 10 weeks after vaccination for those of pregnancy potential
You will not qualify if you...
- Weight less than 40 kg
- Significant exposure to active tuberculosis or recent tuberculin skin test within 6 months
- History or evidence of active tuberculosis disease
- TB preventive therapy within 28 days prior to enrollment or expected during study
- Current active AIDS-defining condition for volunteers with HIV
- Receipt of blood products within 120 days before vaccination
- Receipt of investigational study products (non-vaccine) within 28 days before vaccination
- Pregnancy or breastfeeding
- Prior investigational TB vaccine or BCG vaccination outside infancy
- Investigational non-TB vaccine within last year unless approved
- Live attenuated vaccines within 28 days before or after vaccination
- Non-live vaccines within 14 days prior to vaccination
- Allergy treatment with antigen injections within 28 days before or 14 days after vaccination
- Immunosuppressive medications within 168 days before vaccination except certain corticosteroids
- Serious adverse reactions to vaccines or components including anaphylaxis
- Immunoglobulin received within 90 days before vaccination
- Autoimmune disease (except mild, well-controlled psoriasis)
- Immunodeficiency (except HIV)
- Clinically significant medical or psychiatric conditions interfering with study adherence
- Psychiatric conditions such as recent psychosis or suicide risk
- Asthma requiring frequent corticosteroids, urgent care, hospitalization, or high-dose inhaled steroids
- Diabetes mellitus type 1 or poorly controlled type 2
- Poorly controlled hypertension
- Bleeding disorders
- Malignancy not assured of sustained cure
- Seizure disorder within past 3 years or recent treatment
- Asplenia
- History of angioedema or anaphylaxis with recent episodes
- History of generalized urticaria within past 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Soweto - Gauteng
Johannesburg, Gauteng, South Africa, 1862
Terminated
2
Johannesburg - CHRU
Westdene, Gauteng, South Africa, 2092
Actively Recruiting
3
Durban - Botha's Hill CRS
Durban, KwaZulu-Natal, South Africa, 4001
Actively Recruiting
4
Durban - Wentworth
Durban, KwaZulu-Natal, South Africa, 4052
Terminated
5
Cape Town - UCTLI
Cape Town, Western Cape, South Africa, 7700
Actively Recruiting
6
Cape Town - Emavundleni
Cape Town, Western Cape, South Africa, 7750
Terminated
7
Cape Town - Groote Schuur
Cape Town, Western Cape, South Africa, 7784
Actively Recruiting
8
Worcester - SATVI
Worcester, Western Cape, South Africa, 6850
Actively Recruiting
9
Cape Town - Khayelitsha
Cape Town, South Africa
Actively Recruiting
10
Durban - Chatsworth
Chatsworth, South Africa
Actively Recruiting
11
Durban eThekwini
Durban, South Africa
Terminated
12
Durban - Isipingo
Isipingo, South Africa
Actively Recruiting
13
Klerksdorp
Klerksdorp, South Africa
Actively Recruiting
14
Ladysmith
Ladysmith, South Africa
Actively Recruiting
15
Rustenburg CRS
Rustenburg, South Africa
Terminated
16
Soshanguve
Soshanguve, South Africa
Terminated
Research Team
K
Kylie McCloskey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
12
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