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

Korábbi kezelés

• Receipt of BCG vaccination prior to enrolment.

Más betegség

• 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.
• 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.

Egyéb

• Significant antenatal, intrapartum, or postpartum complications that may affect the health of the newborn.
• Clinically suspected neonatal sepsis.
• Any severe congenital malformation.

• 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.