Trial reportBMC infectious diseases2017
The association between Bacillus Calmette-Guérin vaccination (1331 SSI) skin reaction and subsequent scar development in infants.
Trial report in BMC infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01694108 (Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children. A Prospective, Randomised, Clinical Trial.), which is not on this map. Cited by 13 papers.
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.
Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children. A Prospective, Randomised, Clinical Trial.
Who cites it
13 citing papers in PubMed, 21 citations in OpenAlex.
- Safety of BCG vaccination and revaccination in healthcare workers.Human vaccines & immunotherapeutics · 2023Trial
- Scar among Bacillus Calmette-Guerin Vaccinated Children Presenting to an Immunisation Clinic at a Tertiary Hospital in Nepal: An Observational Study.JNMA; journal of the Nepal Medical Association · 2025Observational
- Potential biomarkers for evaluating the BCG vaccination response based on humoral immunity.Heliyon · 2024Article
- Article
- Evolution of theVaccine: X · 2023Article
- Erratum: Factors influencing scar formation following Bacille Calmette-Guérin (BCG) vaccination.Heliyon · 2023Article
- BCG-Vaccinated Children with Contact to Tuberculosis Patients Show Delayed Conversion ofVaccines · 2023Article
- Factors influencing scar formation following Bacille Calmette-Guérin (BCG) vaccination.Heliyon · 2023Article
- Article
- BCG skin reactions by 2 months of age are associated with better survival in infancy: a prospective observational study from Guinea-Bissau.BMJ global health · 2020Observational
- Article
- Isoniazid Preventative Therapy uptake for child household contacts of tuberculosis index cases, Kisumu County, Kenya, 2014-2015.Journal of public health in Africa · 2019Article
- Determinants of BCG scarification among children in rural Guinea-Bissau: A prospective cohort study.Human vaccines & immunotherapeutics · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Bacillus Calmette-Guérin vaccine (BCG) against tuberculosis is administered intradermally, and vaccination is often followed by a scar at the injection site. Among BCG-vaccinated individuals, having a scar has been associated with lower mortality. We aimed to examine the impact of vaccination technique for scarring in a high income setting, by assessing the associations between the post injection reaction, the wheal size, and the probability of developing a scar, and scar size.
methodsThis study was nested within a clinical multicenter study randomizing 4262 infants to either BCG vaccination (BCG 1331 SSI) or no intervention. In this substudy, including 492 vaccinated infants, the immediate post BCG vaccination reaction was registered as either wheal (a raised, blanched papule at the injection site), bulge (a palpable element at the injection site), or no reaction. The presence or absence of a BCG scar and the size the scar was measured at 13 months of age.
resultsOf 492 infants included, 87% had a wheal after vaccination, 11% had a bulge, and 2% had no reaction. The mean wheal size was 3.8 mm (95% confidence interval 3.7-3.9). Overall, 95% (442/466, 26 lost to follow-up) of BCG-vaccinated infants had a scar at 13 months of age. In infants with a wheal, the probability of developing a scar was 96%, declining to 87% in the case of a bulge, and to 56% in the case of no reaction (p for same probability = 0.03). Wheal size was positively correlated with the probability of getting a scar and scar size.
conclusionScarring after BCG vaccination has been associated with lower infant mortality. In a high-income setting, we found that correct injection technique is highly important for the development of a BCG scar and that registration of the category of BCG skin reaction (as wheal, bulge, or no reaction) may be used to identify infants at risk of scar failure. Finally, the wheal size was positively associated with both the probability of getting a scar and scar size.
trial registrationThe study was registered at www.ClinicalTrials.gov with trial registration number NCT01694108 .
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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.