Evidence map›Paper›PMID 28359325›Full record

Trial reportTrials2017

Early versus late BCG vaccination in HIV-1-exposed infants in Uganda: study protocol for a randomized controlled trial.

Victoria Nankabirwa, James K Tumwine, Olive Namugga, Thorkild Tylleskär, Grace Ndeezi, Bjarne Robberstad, Mihai G Netea, Halvor Sommerfelt

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02606526 (A Randomised Controlled Trial in HIV-1 Exposed Ugandan Infants to Estimate Additional Benefits), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 43% 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.

NCT02606526 phase3completednot on this map

A Randomised Controlled Trial in HIV-1 Exposed Ugandan Infants to Estimate Additional Benefits (Non-specific Effects) of BCG

TypeinterventionalSponsorMakerere UniversityRan2016 to 2024Enrolled4,500ConditionsSevere Illness, Septicaemia, Diarrhoea, Lower Respiratory InfectionArmsBCG at birth, Control arm: Delayed BCG
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. 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

8 authors at 5 institutions in 5 countries.

Victoria NankabirwaDepartment of Epidemiology and Biostatics, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda. nankabirwav@gmail.com.ORCID http://orcid.org/0000-0002-9952-8942
James K TumwineDepartment of Paediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.
Olive NamuggaCentre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen.
Thorkild TylleskärCentre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen.
Grace NdeeziDepartment of Paediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.
Bjarne RobberstadCentre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen.
Mihai G NeteaDepartment of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, Netherlands.
Halvor SommerfeltCentre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen.
International Centre for Reproductive Health · MZMakerere University · UGNorwegian Institute of Public Health · NORadboud University Nijmegen · NLThe Centre for Health (New Zealand) · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBacillus Calmette-Guérin (BCG) vaccination may have nonspecific effects, i.e., effects on childhood morbidity and mortality that go beyond its effect on the risk of childhood tuberculosis (TB). Though the available scientific literature is mostly from observational studies, and is fraught with controversy, BCG vaccination at birth may protect infants in high-mortality populations against serious infections other than TB. Yet, other studies indicate that giving BCG later in infancy may modify immune responses to non-TB antigens and potentially enhance immunity, potentially also against tuberculosis (TB). It is unclear whether BCG vaccination very early in life offers adequate protection against TB and other infections among HIV-1-exposed children because even those who remain uninfected with HIV-1 show signs of impaired immunocompetence early in infancy. This study will compare BCG vaccination at birth with BCG vaccination at 14 weeks of age in HIV-1-exposed infants.

methodsThis is an individually randomized controlled trial in 2200 HIV-1-exposed infants. The intervention is BCG vaccination within 24 h of birth while the comparator is BCG given at 14 weeks of age. The study co-primary outcomes are severe illness in the first 14 weeks of life, and production of tumor necrosis factor, interleukin (IL)-1β, IL-6 and interferon-γ in response to mycobacterial and nonmycobacterial antigens. The study is being conducted in three health centers in Uganda. DISCUSSION: A well-timed BCG vaccination could have important nonspecific effects in HIV-1-exposed infants. This trial could inform the development of appropriate timing of BCG vaccination for HIV-1-exposed infants.

trial registrationClinicalTrials.gov, identifier: NCT02606526 . Registered on 12 November 2015.

Indexed as

Immunization ScheduleVaccinationBCG VaccineBiomarkersClinical ProtocolsCytokinesHIV-1HIV InfectionsHumansImmunity, HeterologousInfantInfant, NewbornInfectious Disease Transmission, VerticalResearch DesignTime FactorsTreatment OutcomeBCG VaccineBiomarkersCytokinesBCGInfants HIV-1-exposedNonspecific effectsTrialVaccination

Identifiers

PMID28359325
PMCPMC5374628
OpenAlexW2597741125

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.