Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa

Launched by BIOFABRI, S.L · Jul 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called MTBVAC, which is designed to help protect newborns from tuberculosis (TB). The goal is to see if MTBVAC is safe and works better than the standard vaccine currently given, known as BCG. The trial is specifically looking at healthy infants born to mothers who are either HIV-infected or HIV-uninfected in sub-Saharan Africa, where TB is very common. Researchers want to learn how well the new vaccine boosts the immune system to fight TB.

To be eligible for this trial, newborns need to be less than a week old, weigh at least 2450 grams, and have a good health check after birth. Their mothers must provide permission for the trial and be in good health, with a documented HIV status. The study will involve regular check-ups to monitor the babies’ health and response to the vaccine. Participating in this trial not only helps advance TB vaccine research but also contributes to a network of healthcare facilities in Africa that can better study and prevent TB in infants.

Gender

ALL

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.