Trial reportThe New England journal of medicine2025
BCG Revaccination for the Prevention of
Trial report in The New England journal of medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Efficacy, immunogenicity, and safety of BCG revaccination against Mycobacterium tuberculosis: A systematic review and meta-analysis.Human vaccines & immunotherapeutics · 2026Pooled it
- Antigen-specific Th1 cytokine markers and protection against tuberculosis: a systematic review and meta-analysis stratified by progression to active disease and sustained IGRA conversion.Frontiers in cellular and infection microbiology · 2026Pooled it
- Reframing evidence on the BCG vaccine: What emerging systematic reviews and meta-analyses reveal about efficacy, safety, and heterogeneity.Human vaccines & immunotherapeutics · 2026Article
- The Flexible Peripheral Segments Modulate the Catalytic Activity of the FAD-Containing Monooxygenase EthA fromBiomolecules · 2026Article
- Antigen-experienced airway CD8Science advances · 2026Article
- γδ T Cells at the Crossroads of Tuberculosis and COPD: From Early Immunity to Tissue Remodeling.International journal of molecular sciences · 2026Review
- mRNA-based tuberculosis vaccines BNT164a1 and BNT164b1 are immunogenic, well tolerated and efficacious in rodent models.Nature immunology · 2026Article
- Adult immunization initiative: Which surrogate markers should be used for vaccine efficacy?The Indian journal of medical research · 2026Article
- Industrial-scale mRNA expertise meets a century of tuberculosis immunology.Nature immunology · 2026Article
- Mucosal BCG Vaccination and Immune Layering: Route-Dependent Programming of Immunity at the Respiratory Interface.Vaccines · 2026Review
- Structural Prediction and Functional Mechanistic Characterization of Farnesyl Diphosphate Synthase fromACS omega · 2026Article
- An ESAT-6-convergent prime-boost vaccination combining recombinant BCG expressing Mycobacterium marinum ESX-1 and ESAT-6/GLA-SE improves TB protection.NPJ vaccines · 2026Article
- Mycobacterium tuberculosis bacteriology and immunity necessitate a multi-pronged immune strategy for vaccination.NPJ vaccines · 2026Review
- Interferon-gamma release assay positivity in populations at high risk of TB infection.IJTLD open · 2026Article
- CD8Nature communications · 2026Article
- A co-evolutionary perspective on humans andeLife · 2026Review
- A Year in Review on Tuberculosis and Non-tuberculous Mycobacteria Disease: A 2026 Update for Clinicians and Scientists.Pathogens & immunity · 2026Review
- How can new TB vaccines be effectively introduced in Indonesia? Insights from diverse stakeholders.PLOS global public health · 2026Article
- Trends and spatial distribution of pulmonary tuberculosis in China: a surveillance study.Frontiers in public health · 2026Article
- Molecular insights into the functional mechanism of phosphoserine phosphatase SerB2 inFrontiers in microbiology · 2026Article
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn a previous phase 2 trial, bacille Calmette-Guérin (BCG) revaccination was not shown to provide protection from primary
methodsWe performed a phase 2b, double-blind, randomized, placebo-controlled trial to evaluate the efficacy of BCG revaccination, as compared with placebo, for the prevention of sustained QFT test conversion (primary end point) in QFT test-negative, human immunodeficiency virus (HIV)-negative adolescents. Adverse events were assessed in a secondary analysis, and immunogenicity was assessed in an exploratory analysis. Vaccine efficacy was evaluated in the modified intention-to-treat population, which included all the participants who had undergone randomization, received the BCG vaccine or placebo, and had a negative QFT test 10 weeks after receipt of BCG vaccine or placebo; the last criterion was added to exclude participants with
resultsA total of 1836 participants underwent randomization; 918 received the BCG vaccine, and 917 received placebo. After a median 30 months of follow-up, a sustained QFT test conversion was observed in 62 of 871 participants in the BCG-vaccine group and 59 of 849 participants in the placebo group. The hazard ratio for a sustained QFT test conversion (BCG vaccine vs. placebo) was 1.04 (95% CI, 0.73 to 1.48), for a vaccine efficacy point estimate of -3.8% (95% CI, -48.3 to 27.4). Adverse events occurred more frequently in the BCG-vaccine group than in the placebo group, and most were due to injection-site reactions (pain, redness, swelling, and ulceration). BCG revaccination induced cytokine-positive type 1 helper CD4 T cells.
conclusionsBCG revaccination in QFT-test negative, HIV-negative adolescents did not provide protection from sustained
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