ArticleVaccine2020
Licensed Bacille Calmette-Guérin (BCG) formulations differ markedly in bacterial viability, RNA content and innate immune activation.
Article in Vaccine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04383925 (Randomized Trial Evaluating the Non-specific Effects of Different BCG Strains in Guinea-Bissau), which is not on this map. Cited by 59 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.
Randomized Trial Evaluating the Non-specific Effects of Different BCG Strains in Guinea-Bissau: Effects on Early-life Mortality and Morbidity
Who cites it
59 citing papers in PubMed, 1 synthesis or guideline pooled it, 87 citations in OpenAlex.
- Immune mechanisms mediating the heterologous effects of BCG vaccination: a systematic review.Frontiers in immunology · 2025Pooled it
- Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).BMJ (Clinical research ed.) · 2025Trial
- Probing Dermal Immunity to Mycobacteria through a Controlled Human Infection Model.ImmunoHorizons · 2024Trial
- Effects of Neonatal BCG-Japan Versus BCG-Russia Vaccination on Overall Mortality and Morbidity: Randomized Controlled Trial From Guinea-Bissau (BCGSTRAIN II).Open forum infectious diseases · 2024Trial
- Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes.Cell reports. Medicine · 2022Trial
- The origin of non-specific effects of vaccines and the role of randomised clinical trials.Human vaccines & immunotherapeutics · 2026Review
- Reframing evidence on the BCG vaccine: What emerging systematic reviews and meta-analyses reveal about efficacy, safety, and heterogeneity.Human vaccines & immunotherapeutics · 2026Article
- BCG vaccination in Korea, Japan, and Taiwan: Current status and future perspectives.Human vaccines & immunotherapeutics · 2026Review
- Bacillus Calmette-Guérin (BCG) immunotherapy reprograms CNS immunity and alters Alzheimer's biomarkers: results from two open-label clinical trials.Communications medicine · 2026Article
- Bacillus Calmette-Guérin (BCG) Vaccination and the Immune-Brain Axis: Implications for Neuroprotection and Neurodegenerative Disease.Vaccines · 2026Review
- The BCGMethodsX · 2025Article
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- PBMC and fibroblast cocultures to mimic themicroPublication biology · 2025Article
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- Revamping the BCG revaccination strategy: Records to recall, or just call it phoenix?Human vaccines & immunotherapeutics · 2024Article
- Article
- Late in the US pandemic, multi-dose BCG vaccines protect against COVID-19 and infectious diseases.iScience · 2024Article
- Preclinical screen for protection efficacy of chlamydial antigens that are immunogenic in humans.Infection and immunity · 2023Article
- IL-23 receptor signaling licenses group 3-like innate lymphoid cells to restrict a live-attenuated oral Chlamydia vaccine in the gut.Infection and immunity · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 6 institutions in 8 countries.
Funding
Abstract
backgroundBacille Calmette-Guérin (BCG), the live attenuated tuberculosis vaccine, is manufactured under different conditions across the globe generating formulations that may differ in clinical efficacy. Innate immune recognition of live BCG contributes to immunogenicity suggesting that differences in BCG viability may contribute to divergent activity of licensed formulations.
methodsWe compared BCG-Denmark (DEN), -Japan (JPN), -India (IND), -Bulgaria (BUL) and -USA in vitro with respect to a) viability as measured by colony-forming units (CFU), mycobacterial membrane integrity, and RNA content, and b) cytokine/chemokine production in newborn cord and adult peripheral blood.
resultsUpon culture, relative growth was BCG-USA > JPN ≫ DEN > BUL = IND. BCG-IND and -BUL demonstrated >1000-fold lower growth than BCG-JPN in 7H9 medium and >10-fold lower growth in commercial Middlebrook 7H11 medium. BCG-IND demonstrated significantly decreased membrane integrity, lower RNA content, and weaker IFN-γ inducing activity in whole blood compared to other BCGs. BCG-induced whole blood cytokines differed significantly by age, vaccine formulation and concentration. BCG-induced cytokine production correlated with CFU, suggesting that mycobacterial viability may contribute to BCG-induced immune responses.
conclusionsLicensed BCG vaccines differ markedly in their content of viable mycobacteria possibly contributing to formulation-dependent activation of innate and adaptive immunity and distinct protective effects.
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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.