NCT04975178 Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
| NCT ID | NCT04975178 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Biofabri, S.L |
| Condition | Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 7,120 participants |
| Start Date | 2022-10-17 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 7,120 participants in total. It began in 2022-10-17 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Male or female newborns within seven days of birth. * Written informed maternal consent, including permission to access maternal antenatal, postnatal, and infant medical records. * Infant participants and their caregivers available for trial follow-up and display the willingness and capacity to comply with trial procedures. * Newborns must be in good general health during pregnancy and delivery, as assessed by medical history and targeted physical examination. * Birth weight ≥ 2450 grams. * Apgar score at 5 minutes ≥ 7. * A maternal HIV test result (rapid test, enzyme-linked immunosorbent assay (ELISA), or Polymerase chain reaction (PCR)) taken within 30 days of delivery, or within seven days post-partum must be available and documented if HIV uninfected. If the mother is HIV infected, then she must be on antiretroviral (ARV) therapy as per in-country guidelines with a viral load of \<50 copies/mL (within six months of labour). * Estimated gestational age ≥ 37 weeks. * Mother has not participated in a clinical trial within three months prior to the infant's birth. * Mother has never participated in a TB vaccine trial before. * Infant may not participate in any other clinical trials. Exclusion Criteria: Receipt of BCG vaccination prior to enrolment. * Significant antenatal, intrapartum, or postpartum complications that may affect the health of the newborn. * Skin condition, bruising or birth mark at the intended injection site. * Maternal HIV test (rapid test, ELISA, or PCR) result not available. * HIV exposed Newborn's HIV PCR result positive or not available. * Maternal history of TB during pregnancy. * History of close/household contact with a TB patient, antenatal or postnatal, whether maternal, other family member or another household member who has not yet completed TB treatment. * Clinically suspected neonatal sepsis. * Any severe congenital malformation. * History or evidence of any systemic disease on examination, or any illness that in the opinion of the Investigator may interfere with the evaluation of the safety and immunogenicity of the vaccine. Neonatal jaundice not considered clinically significant is not an exclusion.
Contact & Investigator
Mark Hatherill
PRINCIPAL INVESTIGATOR
University of Cape Town, Faculty of Health Sciences
Frequently Asked Questions
Who can join the NCT04975178 clinical trial?
This trial is open to participants of all sexes, aged 5 Minutes or older, up to 7 Days, studying Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04975178 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 7,120 participants.
Is NCT04975178 currently recruiting?
Yes, NCT04975178 is actively recruiting participants. Contact the research team at ingrid.murillo@biofabri.es for enrollment information.
Where is the NCT04975178 trial being conducted?
This trial is being conducted at Worcester, South Africa.
Who is sponsoring the NCT04975178 clinical trial?
NCT04975178 is sponsored by Biofabri, S.L. The principal investigator is Mark Hatherill at University of Cape Town, Faculty of Health Sciences. The trial plans to enroll 7,120 participants.