Trial reportVaccine2014
Safety and reactogenicity of BCG revaccination with isoniazid pretreatment in TST positive adults.
Trial report in Vaccine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 I Study of Whether Preclearance of Latent M. Tuberculosis (MTB) Infection With Isoniazid (INH) Enhances Specific Immune Responses to MTB Following Subsequent BCG Revaccination in Healthy, HIV-Uninfected, Tuberculin Skin Test Positive Adults
Bacillus Calmette-Guerin Vaccination as Defense Against SARS-CoV-2: A Randomized Controlled Trial to Protect Health Care Workers by Enhanced Trained Immune Responses
Using BCG Vaccine to Enhance Non-specific Protection of Health Care Workers During the COVID-19 Pandemic. A Randomized Controlled Multi-center Trial
Bacillus Calmette-Guerin Against Covid-19 for Prevention and Amelioration of Severity Trial
Novel Use of an Existing Vaccine (BCG) Alliance: The NUEVA Trial
BCG Vaccine to Reduce Unplanned Absenteeism Due to Illness of Health Care Workers During the COVID-19 Pandemic. A Multi-center Randomised Controlled Trial (BCG-COVID-RCT)
Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly (PARITIE)
The Role of the Bacillus Calmette-Guérin Vaccine (BCG) in the Clinical Evolution of COVID-19 and in the Efficacy of Anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) Vaccines
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Efficacy, immunogenicity, and safety of BCG revaccination against Mycobacterium tuberculosis: A systematic review and meta-analysis.Human vaccines & immunotherapeutics · 2026Pooled it
- A systematic review on malaria and Tuberculosis (TB) vaccine challenges in sub-Saharan African clinical trials.PloS one · 2025Pooled it
- Trial
- BCG revaccination boosts adaptive polyfunctional Th1/Th17 and innate effectors in IGRA+ and IGRA- Indian adults.JCI insight · 2019Trial
- Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination.The New England journal of medicine · 2018Trial
- Sequential inflammatory processes define human progression from M. tuberculosis infection to tuberculosis disease.PLoS pathogens · 2017Trial
- Bacillus Calmette-Guérin (BCG) Revaccination of Adults with Latent Mycobacterium tuberculosis Infection Induces Long-Lived BCG-Reactive NK Cell Responses.Journal of immunology (Baltimore, Md. : 1950) · 2016Trial
- Novel Targets for the Development of Tuberculosis Vaccine.Current drug discovery technologies · 2025Review
- Article
- Article
- The safety of BCG revaccination in the context of COVID-19.Human vaccines & immunotherapeutics · 2023Article
- Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy.NPJ vaccines · 2022Article
- Durable Expansion of TCR-δ Meta-Clonotypes After BCG Revaccination in Humans.Frontiers in immunology · 2022Article
- Therapeutic Vaccines for Tuberculosis: An Overview.Frontiers in immunology · 2022Review
- Rationale for Randomized Clinical Trials Investigating the Potential of BCG Vaccination in Preventing COVID-19 Infection.Bladder cancer (Amsterdam, Netherlands) · 2021Review
- BCG: a vaccine with multiple faces.Human vaccines & immunotherapeutics · 2020Review
- Trained immunity as a novel approach against COVID-19 with a focus on Bacillus Calmette-Guérin vaccine: mechanisms, challenges and perspectives.Clinical & translational immunology · 2020Review
- MR1-Independent Activation of Human Mucosal-Associated Invariant T Cells by Mycobacteria.Journal of immunology (Baltimore, Md. : 1950) · 2019Article
- Age-related waning of immune responses to BCG in healthy children supports the need for a booster dose of BCG in TB endemic countries.Scientific reports · 2018Article
- BCG and New Preventive Tuberculosis Vaccines: Implications for Healthcare Workers.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Article
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 at 5 institutions in 2 countries.
Funding
Abstract
rationaleGlobal tuberculosis (TB) control may require mass vaccination with a new TB vaccine, such as a recombinant bacille Calmette Guerin (BCG) or attenuated Mycobacterium tuberculosis (MTB). The safety profile of live mycobacterial vaccines in latently infected adults with prior infant BCG vaccination is unknown.
objectivesEvaluate safety and reactogenicity of BCG revaccination, with or without isoniazid (INH) pretreatment, in adults with latent MTB infection (LTBI).
methodsEighty-two healthy, HIV uninfected, South African adults, with a BCG scar and tuberculin skin test (TST) diameter ≥ 15 mm, were randomized to receive 6 months of INH, starting either before, or 6 months after, intradermal revaccination with BCG Vaccine SSI (Statens Serum Institut, Copenhagen). Safety and reactogenicity data are reported through 3 months post BCG revaccination.
resultsBaseline characteristics were similar between treatment arms. Mean baseline TST diameter was 20 ± 4 mm. Seventy-two subjects received BCG revaccination. Injection site erythema (68%) and induration (86%) peaked 1 week after revaccination. Ulceration (76%) peaked at 2 weeks, and resolved by 3 months in all but 3 subjects. Diameter of ulceration was >10mm in only 8%, but a residual scar was common (85%). No regional lymphadenitis or serious morbidity related to BCG was seen. Reactogenicity was not affected by INH pretreatment.
conclusionBCG revaccination of MTB infected adults is safe, well tolerated, and reactogenicity is similar to that of primary BCG vaccination. Clinical trials of live recombinant BCG or attenuated MTB vaccines may be considered in latently infected adults, with or without INH pretreatment (ClinicalTrials.gov identifier: NCT01119521).
Indexed as
Identifiers
What OpenQuestion holds
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.