Trial reportThe Journal of infectious diseases2011
Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period?
Trial report in The Journal of infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 9 registered trials, which are not on this map. Cited by 321 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.
Reducing Mortality at the Neonatal Intensive Care Unit in Guinea-Bissau: A Randomized Trial of Providing BCG Vaccination Immediately
Evaluating the Effect of Different BCG Strains on Early Life Hospital Admissions in Guinea-Bissau: A Randomised Trial
Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial
Follow-up of Low Birth Weight Cohort of 2008-2013
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
Randomized Trial Evaluating the Non-specific Effects of Different BCG Strains in Guinea-Bissau: Effects on Early-life Mortality and Morbidity
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)
Use of BCG Vaccine as a Preventive Measure for COVID-19 in Health Care Workers
Who cites it
321 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Interventions to Prevent Post-Discharge Mortality among Children in Sub-Saharan Africa: A Systematic Review.The American journal of tropical medicine and hygiene · 2026Pooled it
- Evidence-based interventions to reduce mortality among preterm and low-birthweight neonates in low-income and middle-income countries: a systematic review and meta-analysis.BMJ global health · 2021Pooled 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
- The influence of neonatal BCG vaccination on in vitro cytokine responses to Plasmodium falciparum.BMC immunology · 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
- Can earlier BCG-Japan and OPV vaccination reduce early infant mortality? A cluster-randomised trial in Guinea-Bissau.BMJ global health · 2024Trial
- Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes.Cell reports. Medicine · 2022Trial
- Bacillus Calmette-Guérin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022Trial
- Efficacy of BCG Vaccination Against Respiratory Tract Infections in Older Adults During the Coronavirus Disease 2019 Pandemic.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Functional in-vitro evaluation of the non-specific effects of BCG vaccination in a randomised controlled clinical study.Scientific reports · 2022Trial
- ACTIVATE-2: A Double-Blind Randomized Trial of BCG Vaccination Against COVID-19 in Individuals at Risk.Frontiers in immunology · 2022Trial
- Efficacy and Safety of BCG Revaccination WithFrontiers in immunology · 2022Trial
- BCG-induced non-specific effects on heterologous infectious disease in Ugandan neonates: an investigator-blind randomised controlled trial.The Lancet. Infectious diseases · 2021Trial
- Neonatal BCG Vaccination Reduces Interferon-γ Responsiveness to Heterologous Pathogens in Infants From a Randomized Controlled Trial.The Journal of infectious diseases · 2020Trial
- Differential effects of BCG vaccine on immune responses induced by vi polysaccharide typhoid fever vaccination: an explorative randomized trial.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2020Trial
- Seasonal variation in the non-specific effects of BCG vaccination on neonatal mortality: three randomised controlled trials in Guinea-Bissau.BMJ global health · 2020Trial
- The origin of non-specific effects of vaccines and the role of randomised clinical trials.Human vaccines & immunotherapeutics · 2026Review
- BCG at 100: The Paradox of an Indispensable Vaccine.Indian pediatrics · 2026Review
- Article
- Review
261 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
backgroundObservational studies have suggested that BCG may have nonspecific beneficial effects on survival. Low-birth-weight (LBW) children are not given BCG at birth in Guinea-Bissau; we conducted a randomized trial of BCG at birth (early BCG) vs delayed BCG.
methodsIn the period 2004-2008 we recruited 2320 LBW children in Bissau. The children were visited at home at 2, 6, and 12 months of age. With a pretrial infant mortality of 250 per 1000, we hypothesized a 25% reduction in infant mortality for LBW children.
resultsInfant mortality was only 101 per 1000 during the trial. In the primary analysis, infant mortality was reduced insignificantly by 17% (mortality rate ratio [MRR] = .83 [.63-1.08]). In secondary analyses, early BCG vaccine was safe with an MRR of .49 (.21-1.15) after 3 days and .55 (.34-.89) after 4 weeks. The reduction in neonatal mortality was mainly due to fewer cases of neonatal sepsis, respiratory infection, and fever. The impact of early BCG on infant mortality was marked for children weighing <1.5 kg (MRR = .43 [.21-.85]) who had lower coverage for diphtheria-tetanus-pertussis vaccinations.
conclusionsThough early BCG did not reduce infant mortality significantly, it may have a beneficial effect in the neonatal period. This could be important for public health because BCG is often delayed in low-income countries.
Indexed as
Identifiers
21673035What 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.