Recruiting

Testing a new tuberculosis vaccine in newborns across Africa

Plain-English translation of NCT04975178 on ClinicalTrials.gov ↗ · Source last updated February 2025 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing a new tuberculosis vaccine called in newborns born to both HIV-infected and HIV-uninfected mothers in three African countries where tuberculosis is common. The medication is a weakened form of the tuberculosis bacterium that researchers believe may protect infants better than the standard vaccine currently used. The trial will compare this new treatment to the traditional tuberculosis vaccine to see if it is safe, effective, and triggers a strong immune response.

Tuberculosis remains a serious global health problem, and a more effective vaccine—especially one designed for newborns who have never been exposed to the disease—could save many lives and help end tuberculosis by 2050. This medication was developed because newborns have immune systems that may respond better to a carefully weakened live vaccine than older children and adults do.

Do you qualify?

You likely qualify if…

your infant is a newborn within seven days of birth
your infant has a birth weight of at least 2450 grams and an Apgar score of 7 or higher at 5 minutes
your infant is in good general health with an estimated gestational age of at least 37 weeks
you have a documented maternal HIV test result taken within 30 days of delivery (or within 7 days after birth)
if the mother is HIV-positive, she must be taking HIV medications with a viral load below 50 copies/mL within the past six months
your infant has not yet received a BCG tuberculosis vaccine

You likely don't qualify if…

your infant has already received a BCG tuberculosis vaccine
your infant has significant birth complications, a skin condition at the injection site, or severe congenital malformations
there is clinically suspected neonatal sepsis or other serious illness in your infant
there is a history of tuberculosis in the mother during pregnancy or close contact with someone who has active tuberculosis in the household
the infant's HIV test result is positive or unavailable (for infants born to HIV-positive mothers)

What participation looks like

If you enroll your newborn, your infant will receive either the new tuberculosis vaccine or the standard vaccine through a small injection into the arm within the first week of life. You and your infant will need to return for follow-up visits so researchers can check that the vaccine is safe and measure how well your infant's immune system responds to it. The trial will involve regular clinic visits, blood samples, and medical record reviews over an extended follow-up period to ensure your infant is healthy and protected.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Testing a new tuberculosis vaccine in newborns across Africa

What is this trial?

Do you qualify?

What participation looks like

Trial locations