Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018
Safety and Immunogenicity of Newborn MVA85A Vaccination and Selective, Delayed Bacille Calmette-Guerin for Infants of Human Immunodeficiency Virus-Infected Mothers: A Phase 2 Randomized, Controlled Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01650389 (Phase II Randomised Controlled Trial to Evaluate Safety and Immunogenicity of MVA85A and Selective, Delayed Bacille Calmette-Guerin), which is not on this map. Cited by 25 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II Randomised Controlled Trial to Evaluate Safety and Immunogenicity of MVA85A and Selective, Delayed Bacille Calmette-Guerin (BCG) Vaccination in Infants of HIV Infected Mothers
Who cites it
25 citing papers in PubMed, 4 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Tuberculosis in children who are HIV-exposed uninfected.AIDS (London, England) · 2026Pooled it
- A systematic review on malaria and Tuberculosis (TB) vaccine challenges in sub-Saharan African clinical trials.PloS one · 2025Pooled it
- Research Advances for Virus-vectored Tuberculosis Vaccines and Latest Findings on Tuberculosis Vaccine Development.Frontiers in immunology · 2022Pooled it
- MVA85A vaccine to enhance BCG for preventing tuberculosis.The Cochrane database of systematic reviews · 2019Pooled it
- Multidimensional analyses reveal modulation of adaptive and innate immune subsets by tuberculosis vaccines.Communications biology · 2020Trial
- Functional, Antigen-Specific Stem Cell Memory (TFrontiers in immunology · 2018Trial
- Tuberculosis vaccines and therapeutic drug: challenges and future directions.Molecular biomedicine · 2025Review
- BCG vaccination: historical role, modern applications, and future perspectives in tuberculosis and beyond.Frontiers in pediatrics · 2025Review
- BCG and beyond: unlocking new frontiers in TB vaccine development.Frontiers in immunology · 2025Review
- Leveraging computer-aided design and artificial intelligence to develop a next-generation multi-epitope tuberculosis vaccine candidate.Infectious medicine · 2024Article
- Bioinformatics Analysis and Immunogenicity Assessment of the Novel Multi-Stage DNA Vaccine W541 Against Mycobacterium Tuberculosis.Immunity, inflammation and disease · 2024Article
- Tuberculosis vaccine developments and efficient delivery systems: A comprehensive appraisal.Heliyon · 2024Review
- Enhancing TB Vaccine Efficacy: Current Progress on Vaccines, Adjuvants and Immunization Strategies.Vaccines · 2023Review
- Review
- What's Old and New in Tuberculosis Vaccines for Children.Journal of the Pediatric Infectious Diseases Society · 2022Article
- Kinetics of the B- and T-Cell Immune Responses After 6 Months From SARS-CoV-2 mRNA Vaccination in Patients With Rheumatoid Arthritis.Frontiers in immunology · 2022Article
- Fusion peptide constructs from antigens of M. tuberculosis producing high T-cell mediated immune response.PloS one · 2022Article
- PE_PGRS33, an Important Virulence Factor ofCells · 2021Review
- COVID-19 vaccine development: What lessons can we learn from TB?Annals of clinical microbiology and antimicrobials · 2020Review
- Neonatal and infant immunity for tuberculosis vaccine development: importance of age-matched animal models.Disease models & mechanisms · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 5 institutions in 3 countries.
Funding
Abstract
Background: Vaccination of human immunodeficiency virus (HIV)-infected infants with bacille Calmette-Guérin (BCG) is contraindicated. HIV-exposed newborns need a new tuberculosis vaccination strategy that protects against tuberculosis early in life and avoids the potential risk of BCG disease until after HIV infection has been excluded. Methods: This double-blind, randomized, controlled trial compared newborn MVA85A prime vaccination (1 × 108 PFU) vs Candin® control, followed by selective, deferred BCG vaccination at age 8 weeks for HIV-uninfected infants and 12 months follow-up for safety and immunogenicity. Results: A total of 248 HIV-exposed infants were enrolled. More frequent mild-moderate reactogenicity events were seen after newborn MVA85A vaccination. However, no significant difference was observed in the rate of severe or serious adverse events, HIV acquisition (n = 1 per arm), or incident tuberculosis disease (n = 5 MVA85A; n = 3 control) compared to the control arm. MVA85A vaccination induced modest but significantly higher Ag85A-specific interferon gamma (IFNγ)+ CD4+ T cells compared to control at weeks 4 and 8 (P < .0001). BCG did not further boost this response in MVA85A vaccinees. The BCG-induced Ag85A-specific IFNγ+ CD4+ T-cell response at weeks 16 and 52 was of similar magnitude in the control arm compared to the MVA85A arm at all time points. Proliferative capacity, functional profiles, and memory phenotype of BCG-specific CD4 responses were similar across study arms. Conclusions: MVA85A prime vaccination of HIV-exposed newborns was safe and induced an early modest antigen-specific immune response that did not interfere with, or enhance, immunogenicity of subsequent BCG vaccination. New protein-subunit and viral-vectored tuberculosis vaccine candidates should be tested in HIV-exposed newborns. Clinical Trials Registration: NCT01650389.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.