Trial reportThe Journal of infectious diseases2015
Delaying BCG vaccination until 8 weeks of age results in robust BCG-specific T-cell responses in HIV-exposed infants.
Trial report in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02062580 (Influence of BCG Immunization on Immune Responses and Disease Progression in South African HIV Exposed and Infected Infants), which is not on this map. Cited by 18 papers, 1 of them a synthesis 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.
Influence of BCG Immunization on Immune Responses and Disease Progression in South African HIV Exposed and Infected Infants
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- A systematic review on malaria and Tuberculosis (TB) vaccine challenges in sub-Saharan African clinical trials.PloS one · 2025Pooled it
- 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.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Trial
- Bacillus Calmette-Guérin vaccination at birth and in vitro cytokine responses to non-specific stimulation. A randomized clinical trial.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2018Trial
- Trial
- Immunogenicity of BCG in HIV-exposed and non-exposed infants following routine birth or delayed vaccination.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2015Trial
- Review
- An Update on Tuberculosis Vaccines.Methods in molecular biology (Clifton, N.J.) · 2022Article
- BCG Vaccination and Mother-to-Infant Transmission of HIV.The Journal of infectious diseases · 2020Article
- MR1-Independent Activation of Human Mucosal-Associated Invariant T Cells by Mycobacteria.Journal of immunology (Baltimore, Md. : 1950) · 2019Article
- Impact of maternal HIV exposure, feeding status, and microbiome on infant cellular immunity.Journal of leukocyte biology · 2019Review
- Bacille Calmette-Guérin Vaccine Strain Modulates the Ontogeny of Both Mycobacterial-Specific and Heterologous T Cell Immunity to Vaccination in Infants.Frontiers in immunology · 2019Article
- What Have We Learnt about BCG Vaccination in the Last 20 Years?Frontiers in immunology · 2017Review
- T Cell Activation in South African HIV-Exposed Infants Correlates with Ochratoxin A Exposure.Frontiers in immunology · 2017Article
- Current status of new tuberculosis vaccine in children.Human vaccines & immunotherapeutics · 2016Review
- Paediatric HIV infection: the potential for cure.Nature reviews. Immunology · 2016Review
- Immune activation and paediatric HIV-1 disease outcome.Current opinion in HIV and AIDS · 2016Review
- Reply to Thysen et al.The Journal of infectious diseases · 2015Article
- Applications of bacillus Calmette-Guerin and recombinant bacillus Calmette-Guerin in vaccine development and tumor immunotherapy.Expert review of vaccines · 2015Review
Corrections and comments
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Authors and funding
9 authors at 2 institutions in 2 countries.
Funding
Abstract
backgroundBCG vaccination prevents disseminated tuberculosis in children, but it is contraindicated for persons with human immunodeficiency virus (HIV) infection because it can result in severe disease in this population. In tuberculosis-endemic regions, BCG vaccine is administered soon after birth, before in utero and peripartum HIV infection is excluded. We therefore assessed the immunogenicity of BCG vaccine in HIV-exposed infants who received BCG at birth or at 8 weeks of age.
methodsHIV-exposed, uninfected infants were randomly assigned to receive BCG vaccination at birth (the early vaccination arm) or 8 weeks of age (the delayed vaccination arm). BCG-specific proliferative and intracellular cytokine responses were assessed in 28 infants per arm at 6, 8, and 14 weeks of life.
resultsThere was no difference in BCG-specific T-cell proliferation between the study arms 6 weeks after vaccination. However, at 14 weeks of age, the frequency of interferon γ-expressing CD4(+) T cells and multifunctional BCG-specific responses in the delayed vaccinated arm were significantly higher than those in the early vaccination arm (P = .021 and P = .011, respectively).
conclusionsThe immunogenicity of BCG vaccination in HIV-exposed, uninfected infants is not compromised when delayed until 8 weeks of age and results in robust BCG-specific T-cell responses at 14 weeks of age. These findings support further evaluation of this modified BCG vaccination strategy for HIV-exposed infants. CLINICAL TRIALS REGISTRATION: NCT02062580.
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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.