Actively Recruiting
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
Led by Biofabri, S.L · Updated on 2025-02-10
7120
Participants Needed
1
Research Sites
328 weeks
Total Duration
On this page
Sponsors
B
Biofabri, S.L
Lead Sponsor
T
TuBerculosis Vaccine Initiative
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this project is to demonstrate safety, immunogenicity and improved efficacy of the new live attenuated M. tuberculosis vaccine called MTBVAC in a Phase 3 efficacy trial in HIV-uninfected infants born to HIV-infected and HIV-uninfected mothers as compared to standard of care BCG vaccination. The proposal builds upon a group of TB vaccine development partners in Europe and sub-Saharan Africa established in a previous EDCTP-supported project. It creates an expanded consortium of clinical trial partners for the optimal implementation of a large infant efficacy trial of MTBVAC in high TB incidence settings. New capacity for efficacy trials in infants will be a valuable resource for the TB vaccine development community. The proposal will create a network of institutions in three TB endemic African countries with enhanced laboratory capacity to conduct TB vaccine immunology studies and to bio-bank samples to discover immune correlates of vaccine-mediated protection.
CONDITIONS
Official Title
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborns (male or female) within seven days of birth
- Written informed consent from the mother, including access to maternal and infant medical records
- Availability and willingness of infant and caregiver to comply with study follow-up
- Good general health of newborn during pregnancy and delivery as assessed by medical history and examination
- Birth weight of at least 2450 grams
- Apgar score of 7 or higher at 5 minutes after birth
- Maternal HIV test result available within 30 days before or 7 days after delivery; if HIV infected, mother must be on antiretroviral therapy with viral load below 50 copies/mL within six months of labor
- Gestational age of at least 37 weeks
- Mother has not participated in a clinical trial within 3 months before infant's birth
- Mother has never participated in a TB vaccine trial before
- Infant is not enrolled in any other clinical trial
You will not qualify if you...
- Receipt of BCG vaccination before enrollment
- Significant pregnancy or birth complications affecting newborn health
- Skin condition, bruising, or birth mark at the vaccine injection site
- Maternal HIV test result not available
- HIV exposed newborn with positive or unavailable HIV PCR test
- Maternal history of tuberculosis during pregnancy
- Close contact with a tuberculosis patient who has not completed treatment
- Clinically suspected newborn sepsis
- Severe congenital malformations
- Any systemic disease or illness that may interfere with vaccine safety or immune response evaluation (excluding mild neonatal jaundice)
AI-Screening
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Trial Site Locations
Total: 1 location
1
South African Tuberculosis Initiative, Brewelskloof Hospital
Worcester, Western Cape, South Africa, 6850
Actively Recruiting
Research Team
I
Ingrid Murillo Jelsbak
CONTACT
A
Andrea García Silva
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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