Evidence map›Paper›PMID 25860002›Full record

Trial reportThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2015

Immunogenicity of BCG in HIV-exposed and non-exposed infants following routine birth or delayed vaccination.

A C Hesseling, H B Jaspan, G F Black, N Nene, G Walzl

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 19% of its field
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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Tuberculosis susceptibility and protection in children.The Lancet. Infectious diseases · 2019
    Review
  9. Review
  10. Reply to Thysen et al.The Journal of infectious diseases · 2015
    Article
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

5 authors at 3 institutions in 1 country.

A C HesselingDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
H B JaspanDivision of Immunology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town Health Sciences Faculty, Cape Town, South Africa; Seattle Children's Research Institute, Seattle, Washington, USA.
G F BlackDepartment of Science and Technology/National Research Foundation Centre of Excellence for Biomedical TB Research/Medical Research Council Centre for Molecular and Cellular Biology, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
N NeneDepartment of Science and Technology/National Research Foundation Centre of Excellence for Biomedical TB Research/Medical Research Council Centre for Molecular and Cellular Biology, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
G WalzlDepartment of Science and Technology/National Research Foundation Centre of Excellence for Biomedical TB Research/Medical Research Council Centre for Molecular and Cellular Biology, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
Stellenbosch University · ZADesmond Tutu HIV Foundation · ZANational Research Foundation · ZA

Funding

Assessing feeding practices, immune activation, and HIV risk in African infantsK08HD069201 · NICHD · SEATTLE CHILDREN'S HOSPITAL · PI JASPAN, HEATHER BERYL · 2011 to 2015
$644k
NICHD NIH HHS K08 HD 069201NICHD NIH HHS K08 HD069201
6 · The paper itself

Abstract

backgroundHuman immunodeficiency virus (HIV) exposed infants are at high risk of Mycobacterium tuberculosis exposure, have high rates of progression to tuberculosis (TB) disease and are at significant risk of bacille Calmette-Guérin (BCG) induced adverse events.

objectiveTo evaluate a delayed BCG vaccination strategy in HIV-exposed infants.

designA randomised trial of routine BCG vaccination given at birth compared to 14 weeks of age in HIV-exposed non-infected and non-HIV-exposed infants to investigate longitudinal BCG-induced immune responses using a 7-day whole blood interferon-gamma (IFN-γ) enzyme-linked immunosorbent assay.

resultsA significantly higher proportion of infants had positive responses to M. tuberculosis purified protein derivative (PPD) and BCG at 14 weeks in the birth vs. delayed vaccination groups (P = 0.001 for both). This difference was no longer apparent at weeks 24 or 52. Among infants vaccinated at birth, the 14-week IFN-γ response to M. tuberculosis PPD was lower among HIV-exposed than non-exposed infants (276.5 pg/ml vs. 790.2, P = 0.048). Among all infants, there were significant correlations between the magnitude of IFN-γ responses to BCG, M. tuberculosis PPD, TB 10.4 and culture filtrate protein 10/early secreted antigenic target 6.

conclusionsThe timing of vaccination had limited effect on BCG-induced IFN-γ responses, which waned considerably over 1 year despite initial vigorous responses in both vaccination groups. The lower responses in HIV-exposed non-infected infants suggest potentially altered mycobacterial immunity early in life.

Indexed as

VaccinationAntibody FormationBCG VaccineEnzyme-Linked Immunosorbent AssayFemaleHIV InfectionsHumansInfantInterferon-gammaMaleTuberculosisBCG VaccineInterferon-gamma

Identifiers

PMID25860002
PMCPMC4530999
OpenAlexW2322357999

What OpenQuestion holds

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Registered trials

None linked

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.