Trial reportThe Journal of infectious diseases2016
Optimization of a Human Bacille Calmette-Guérin Challenge Model: A Tool to Evaluate Antimycobacterial Immunity.
Trial report in The Journal of infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02088892 (A Clinical Challenge Study to Quantify BCG at the Challenge Site of Healthy Volunteers Receiving Either Intradermal BCG SSI or BCG TICE at Standard or High Dose), which is not on this map. Cited by 23 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.
A Clinical Challenge Study to Quantify BCG at the Challenge Site of Healthy Volunteers Receiving Either Intradermal BCG SSI or BCG TICE at Standard or High Dose
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Development and application of the direct mycobacterial growth inhibition assay: a systematic review.Frontiers in immunology · 2024Pooled it
- Early mucosal responses following a randomised controlled human inhaled infection with attenuated Mycobacterium bovis BCG.Nature communications · 2025Trial
- Probing Dermal Immunity to Mycobacteria through a Controlled Human Infection Model.ImmunoHorizons · 2024Trial
- Article
- Exploring the ethics of tuberculosis human challenge models.Journal of medical ethics · 2026Article
- Controlled human infection with Mycobacterium tuberculosis: practical considerations for clinical trials.The Lancet. Microbe · 2026Review
- The BCGMethodsX · 2025Article
- The mark of success: The role of vaccine-induced skin scar formation for BCG and smallpox vaccine-associated clinical benefits.Seminars in immunopathology · 2024Review
- Review of Current Tuberculosis Human Infection Studies for Use in Accelerating Tuberculosis Vaccine Development: A Meeting Report.The Journal of infectious diseases · 2024Article
- Molecular detection of pre-ribosomal RNAs of Mycobacterium bovis bacille Calmette-Guérin and Mycobacterium tuberculosis to enhance pre-clinical tuberculosis drug and vaccine development.Diagnostic microbiology and infectious disease · 2024Article
- Challenges in Developing a Controlled Human Tuberculosis Challenge Model.Current topics in microbiology and immunology · 2024Review
- A dose escalation study to evaluate the safety of an aerosol BCG infection in previously BCG-vaccinated healthy human UK adults.Frontiers in immunology · 2024Article
- A feasibility study of controlled human infection with intradermal Bacillus Calmette-Guérin (BCG) injection: Pilot BCG controlled human infection model.Wellcome open research · 2023Article
- Controlled human infection models in COVID-19 and tuberculosis: current progress and future challenges.Frontiers in immunology · 2023Review
- Immune cell interactions in tuberculosis.Cell · 2022Review
- New Developments and Insights in the Improvement ofCurrent epidemiology reports · 2021Review
- Tuberculosis Vaccine Development: Progress in Clinical Evaluation.Clinical microbiology reviews · 2019Review
- Consensus Report on Shigella Controlled Human Infection Model: Introduction and Overview.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Article
- Review
- Designing tuberculosis vaccine efficacy trials - lessons from recent studies.Expert review of vaccines · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundThere is an urgent need for an improved tuberculosis vaccine. The lack of a validated correlate of protection slows progress in achieving this goal. A human mycobacterial challenge model, using bacille Calmette-Guérin (BCG) as a surrogate for a Mycobacterium tuberculosis challenge, would facilitate vaccine selection for field efficacy testing. Optimization of this model is required.
methodsHealthy BCG-naive adults were assigned to receive intradermal standard-dose BCG SSI (group A), standard-dose BCG TICE (group B), high-dose BCG SSI (group C), and high-dose BCG TICE (group D). Two weeks after BCG challenge, skin biopsy of the challenge site was performed. BCG mycobacterial load was quantified by solid culture and quantitative polymerase chain reaction.
resultsBCG was well tolerated, and reactogenicity was similar between groups, regardless of strain and dose. There was significantly greater recovery of BCG from the high-dose challenge groups, compared with standard-dose challenge. BCG strain did not significantly affect BCG recovery.
conclusionsBCG challenge dose affects sensitivity of this model. We have selected high-dose BCG SSI to take forward in future challenge studies. Assessment of candidate tuberculosis vaccine effectiveness with this optimized model could contribute to vaccine selection for efficacy trials. CLINICAL TRIALS REGISTRATION: NCT02088892.
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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.