Evidence map›Paper›PMID 41459544›Full record

SynthesisFrontiers in immunology2025

Incidence, risk factors and outcomes of BCGosis following BCG vaccination in infants: a systematic review and meta-analyses.

Fathima Raahima Riyas Mohamed, Mudasar Nisar, Ismail Saeed, Mohammed Rushdhi Irfan, Ahlaam Khalid, Muneeb Faiz, Ahmed F Younis, Shahan Javed, Arya Sen, Asma Azam and 4 more

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Fathima Raahima Riyas MohamedCollege of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Mudasar NisarServices Institute of Medical Sciences, Lahore, Pakistan.
Ismail SaeedCollege of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Mohammed Rushdhi IrfanCollege of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Ahlaam KhalidGomal Medical College, Dera Ismail Khan, Pakistan.
Muneeb FaizKing Edward Medical University, Lahore, Pakistan.
Ahmed F YounisDamietta Faculty of Medicine, Al-Azhar University, Cairo, Egypt.
Shahan JavedCollege of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Arya SenKolkata Medical College, Kolkata, West Bengal, India.
Asma AzamKarachi Medical and Dental College (KMDC), Karachi, Pakistan.
Muhabat Adeola RajiDepartment of Microbiology/Immunology, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Abrar BarakzaiDepartment of Pathology, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Atef Mohamed ShiblDepartment of Microbiology/Immunology, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Garwin Kim SingDepartment of Microbiology/Immunology, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The Bacille Calmette-Guerin (BCG) vaccine is widely administered in countries with high tuberculosis (TB) prevalence to protect against severe forms of childhood TB. Despite its efficacy, the vaccine can lead to adverse effects like BCGosis, a severe but rare condition marked by systemic granulomatous inflammation. This is because the vaccine is comprised of attenuated BCG bacteria which has the potential to cause uncontrolled dissemination beyond the injection site. Immunocompromised children are particularly vulnerable to this side effect. Through a systematic review of the current literature, this analysis seeks to determine the global incidence of BCGosis and identify critical risk factors associated with its onset. Methods: The review was conducted in accordance with the PRISMA-2020 guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). The review's objectives and scope were framed using the PICOS (Population, Intervention, Comparison, Outcomes and Study Design) framework. Results: Not surprisingly, BCGosis is most prevalent in infants with underlying genetic immunodeficiencies such as severe combined immunodeficiency (SCID) and chronic granulomatous disease (CGD). We found a high correlation between the development of BCGosis and genetic mutations affecting certain immune processes, notably those involved in NADPH oxidase function and interferon-gamma signalling. The risks of developing these mutations also correlated with the prevalence of consanguinity, a common practice in certain populations. Factors like early neonatal vaccination (often within the first week of life) and variations in BCG strains may also influence BCGosis risk. Conclusion: There is an urgent need for enhanced pre-vaccination screening for genetic and immunologic vulnerabilities in infants at hight risk for BCGosis, particularly in populations with high consanguinity rates. Alternatively, considerations should be made as to modifying existing vaccination schedules or postponing BCG immunization until immune competency can be confirmed in these high risk groups.

Indexed as

BCG VaccineTuberculosisVaccinationHumansIncidenceInfantRisk FactorsSevere Combined ImmunodeficiencyBCG VaccineBcgosisBCG vaccineimmunodeficiencyneonatal vaccinationtuberculosis

Identifiers

PMID41459544
PMCPMC12738926

What OpenQuestion holds

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Registered trials

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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.