> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-safety-and-immunogenicity-evaluation-of-mtbvac-in-5711e093-a052-47fa-a7fc-5c0b3c19d626 > Record changed: 2026-10-13 # Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa NCT04975178 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) Participants 7,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) Lead sponsor Biofabri, S.L Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) Start date 2022-10-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Acronym** MTBVACN3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Short title** Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Official title** Randomised, Double-Blind, Controlled Phase 3 Trial to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Healthy HIV Unexposed (HU) and HIV Exposed Uninfected (HEU) Newborns in Tuberculosis-Endemic Regions of Sub-Saharan Africa Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Dates **Completion date** 2029-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **First posted** 2021-07-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Registry last updated** 2025-02-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Primary completion date** 2029-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Start date** 2022-10-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Size and sites **Participants** 7,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Planned participants** 7,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Lead sponsor** Biofabri, S.L Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Identifiers **Registry ID** NCT04975178 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **ClinicalTrials.gov ID** NCT04975178 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** MTBVAC and BCG vaccine will be prepared, and allocation concealed by the site pharmacist. All other site staff will be blinded to vaccine allocation, throughout the follow-up period. Data pertaining to the MTBVAC vaccine and to BCG control will be collected in an observer-blinded manner. Blinding will be maintained throughout the vaccination and follow-up portions of the vaccine trial. No set of individual codes will be held at Biofabri's Headquarters. Biofabri's Headquarters will be able to access the individual randomization code from the SATVI Pharmacy randomization register. The code will be broken by the Site's Pharmacist (Study Contact for Emergency Code Break) only in the case of medical events that the investigator/physician in charge of the participant feels cannot be treated without knowing the identity of the study vaccine(s). The Site's Pharmacist is responsible for unblinding the treatment assignment in accordance with specified time frames for expedited reporting of SAEs. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Outcomes ### Primary outcomes 1. To demonstrate efficacy in terms of incidence of MTBVAC against TB disease in healthy HU and HEU newborns compared to BCG Timeframe: Minimum of 24 months to a maximum 80 months; or until study end in South Africa. Primary: Time from vaccination to diagnosis of first confirmed or unconfirmed TB disease, which might be right-censored due to loss to follow-up, death, or successful completion of the study without acquiring TB disease from day of vaccination. Secondary: Confirmed TB disease, which might be right-censored due to loss to follow-up, death, or successful completion of the study without acquiring TB from day of vaccination. Exploratory: i) Time from vaccination to diagnosis of first unconfirmed or unlikely TB disease, which might be right-censored due to loss to follow-up, death, or successful completion of the study without acquiring TB disease from day of vaccination. ii) Confirmed or unconfirmed TB, which might be right-censored due to loss to follow-up, death, or successful completion of the study without acquiring TB carried out with a washout period of 90 days after vaccination. iii) Confirmed TB disease; iv) Unconfirmed or unlikely TB disease (ver ii for iii and iv). ### Secondary outcomes 1. To assess the safety and reactogenicity of MTBVAC in healthy HU and HEU newborns compared to BCG. Timeframe: Minimum of 24 months to a maximum 80 months; or until study end in South Africa. Incidence and severity of: Solicited AEs; Local solicited AEs (injection-site reactions): pain, erythema (redness), swelling, and induration (collected up to Day 10), and ulceration, drainage/discharge, and scarring (collected up to Day 56); Systemic solicited AEs: fever, irritability, vomiting, diarrhea, and skin rash (collected up to Day 10). Unsolicited AEs: MAAEs; Medically un-attended AEs. Solicited AEs with onset after Day 10: Local solicited AEs (injection-site reactions): pain, erythema (redness), swelling, and induration. Systemic solicited AEs: fever, irritability, vomiting, diarrhea, and skin rash. Solicited AEs with onset after Day 56: ulceration, drainage/discharge, and scarring; AESIs, SAEs Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 5 Minutes **Maximum age** 7 Days **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Sites - South African Tuberculosis Initiative, Brewelskloof HospitalWorcester, South AfricaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## References - PubMed 31416768 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/31416768/) Background - PubMed 26598141 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/26598141/) Background - PubMed 23965219 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/23965219/) Background - PubMed 28706226 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/28706226/) Background - PubMed 22267721 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/22267721/) Background - PubMed 10564470 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/10564470/) Background - PubMed 25211768 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/25211768/) Background - PubMed 29326700 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/29326700/) Background - PubMed 18946503 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/18946503/) Background - PubMed 22448023 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/22448023/) Background - PubMed 15893612 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/15893612/) Background - PubMed 25288770 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/25288770/) Background - PubMed 20822958 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/20822958/) Background - PubMed 27247343 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/27247343/) Background - PubMed 27798628 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/27798628/) Background - PubMed 31661198 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/31661198/) Background - PubMed 23391465 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/23391465/) Background - PubMed 20074686 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/20074686/) Background - PubMed 33397991 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/33397991/) Background - PubMed 1316826 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/1316826/) Background - PubMed 39752894 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39752894/) Related publication - Related resource (www.who.int) Source: [www.who.int](https://www.who.int/publications/i/item/9789240061729) - Related resource (cdn.who.int) Source: [cdn.who.int](https://cdn.who.int/media/docs/default-source/immunization/product-and-delivery-research/framework%5Fworking%5Fdocument%5Fjuly%5F2023.pdf?sfvrsn=224b6151%5F3&download=true) - Related resource (rsc.niaid.nih.gov) Source: [rsc.niaid.nih.gov](https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04975178) ## Related records ### Drugs (1) - [BCG vaccine](https://trialight.com/data/asset/bcg-vaccine-6209b6c5-8e23-4284-bbce-49f9b521e4df.md) ### Collaborators (8) - Biomedical Research Center EPLS - Institut Pasteur de Madagascar - TuBerculosis Vaccine Initiative - Universidad de Zaragoza - University of Cape Town - University of KwaZulu - University of Stellenbosch - Wits Health Consortium (Pty) Ltd ### Lead sponsors (1) - [Biofabri, S.L](https://trialight.com/data/company/biofabri-s-l-f0947c8e-a15f-4af4-90fd-fa14da5053e7.md) ### Conditions (1) - [Tuberculosis](https://trialight.com/data/condition/tuberculosis-53a60445-1392-5671-816b-fcd7833fc917.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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