Tuberculosis
Conditions
Interventions
BCG SSI vaccine
Sponsors
BIOFABRI S.L.U.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria at the time of randomization in order to be enrolled: ? 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
Exclusion criteria: Participant Exclusion Criteria If any of the following criteria are met at the time of randomization the participant may not be enrolled: ? 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate efficacy of MTBVAC against tuberculosis disease in healthy HU and HEU neonates compared to BCG | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and reactogenicity of MTBVAC in healthy HU and HEU newborns compared to BCG ;To biobank samples for (future) biomarker studies to identify immunological correlates of vaccine-induced protection and biomarkers of risk for TB disease. | — |
Countries
Madagascar, Senegal, South Africa
Contacts
Public ContactIngrid Murillo Jelsbak
Sponsor Trial Manager and Clinical Research Director
Outcome results
None listed