RecruitingPhase 2NCT05947890

Evaluating the Safety and Immunogenicity of MTBVAC

A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of MTBVAC


Sponsor

HIV Vaccine Trials Network

Enrollment

276 participants

Start Date

Jan 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 12 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study (HVTN 605) is testing the safety and immune response to MTBVAC — an experimental tuberculosis (TB) vaccine — in healthy adults and people living with HIV. TB is a leading infectious disease killer worldwide, and MTBVAC is being tested as a potentially more effective replacement for the current BCG vaccine. **You may be eligible if...** - You are between 12 and 55 years old and received the BCG vaccine as an infant - You are in good general health based on exams and lab tests - You are HIV-negative with a low likelihood of acquiring HIV, OR you are HIV-positive on stable treatment with an undetectable viral load and an adequate immune cell count - You are willing to use contraception if there is a chance of pregnancy **You may NOT be eligible if...** - You weigh less than 40 kg - You have been recently exposed to TB, have a history of active TB, or are showing signs of active TB - You are pregnant or breastfeeding - You have an autoimmune disease, uncontrolled diabetes, poorly controlled asthma, or a bleeding disorder - You received certain vaccines, blood products, or immune-suppressing drugs recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMTBVAC

The MTBVAC vaccine is a freeze-dried lyophilized pellet containing live attenuated strain MTBVAC01 derived from Mycobacterium tuberculosis (M.tb). Excipients include sucrose and sodium glutamate.

BIOLOGICALBCG

The active substance in BCG vaccine is a freeze-dried powder containing live attenuated Mycobacterium bovis BCG, Danish strain 1331 and sodium glutamate as a stabilizer. The powder is white and crystalline and may be difficult to see due to the small amount contained in each vial.


Locations(16)

Soweto - Gauteng

Johannesburg, Gauteng, South Africa

Johannesburg - CHRU

Westdene, Gauteng, South Africa

Durban - Botha's Hill CRS

Durban, KwaZulu-Natal, South Africa

Durban - Wentworth

Durban, KwaZulu-Natal, South Africa

Cape Town - UCTLI

Cape Town, Western Cape, South Africa

Cape Town - Emavundleni

Cape Town, Western Cape, South Africa

Cape Town - Groote Schuur

Cape Town, Western Cape, South Africa

Worcester - SATVI

Worcester, Western Cape, South Africa

Cape Town - Khayelitsha

Cape Town, South Africa

Durban - Chatsworth

Chatsworth, South Africa

Durban eThekwini

Durban, South Africa

Durban - Isipingo

Isipingo, South Africa

Klerksdorp

Klerksdorp, South Africa

Ladysmith

Ladysmith, South Africa

Rustenburg CRS

Rustenburg, South Africa

Soshanguve

Soshanguve, South Africa

View Full Details on ClinicalTrials.gov

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NCT05947890


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