Evidence map›Paper›PMID 27974398›Full record

Trial reportClinical and vaccine immunology : CVI2017

Safety and Immunogenicity of the Recombinant Mycobacterium bovis BCG Vaccine VPM1002 in HIV-Unexposed Newborn Infants in South Africa.

André G Loxton, Julia K Knaul, Leander Grode, Andrea Gutschmidt, Christiane Meller, Bernd Eisele, Hilary Johnstone, Gian van der Spuy, Jeroen Maertzdorf, Stefan H E Kaufmann and 3 more

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

Trial report in Clinical and vaccine immunology : CVI, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 95 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 4 pooled it
10.4field-weighted citation impact, top 1% 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

95 citing papers in PubMed, 4 syntheses or guidelines pooled it, 155 citations in OpenAlex.

  1. Pooled it
  2. Delayed-Type Hypersensitivity toInternational journal of molecular sciences · 2026
    Pooled it
  3. Pooled it
  4. Pooled it
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  15. Article
  16. Host Immune Response toJournal of inflammation research · 2025
    Review
  17. Article
  18. Review
  19. Vaccines · 2024
    Review
  20. Review

35 more citing papers are in PubMed but not listed here.

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

13 authors at 3 institutions in 2 countries.

André G LoxtonSA MRC Centre for TB Research, DST/NRF Centre of Excellence for Biomedical Tuberculosis Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Julia K KnaulVakzine Projekt Management, GmbH, Hanover, Germany.
Leander GrodeVakzine Projekt Management, GmbH, Hanover, Germany.
Andrea GutschmidtSA MRC Centre for TB Research, DST/NRF Centre of Excellence for Biomedical Tuberculosis Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Christiane MellerVakzine Projekt Management, GmbH, Hanover, Germany.
Bernd EiseleVakzine Projekt Management, GmbH, Hanover, Germany.
Hilary JohnstoneHJ Clinical Trials Consultancy CC, George, South Africa.
Gian van der SpuySA MRC Centre for TB Research, DST/NRF Centre of Excellence for Biomedical Tuberculosis Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Jeroen MaertzdorfMax Planck Institute for Infection Biology, Department of Immunology, Berlin, Germany.
Stefan H E KaufmannMax Planck Institute for Infection Biology, Department of Immunology, Berlin, Germany.
Anneke C HesselingDesmond Tutu TB Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
Gerhard WalzlSA MRC Centre for TB Research, DST/NRF Centre of Excellence for Biomedical Tuberculosis Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Mark F CottonFam-Cru, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa mcot@sun.ac.za.
South African Medical Research Council · ZAStellenbosch University · ZAMax Planck Institute for Infection Biology · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tuberculosis is a global threat to which infants are especially vulnerable. Effective vaccines are required to protect infants from this devastating disease. VPM1002, a novel recombinant Mycobacterium bovis bacillus Calmette-Guérin (BCG) vaccine previously shown to be safe and immunogenic in adults, was evaluated for safety in its intended target population, namely, newborn infants in a region with high prevalence of tuberculosis. A total of 48 newborns were vaccinated intradermally with VPM1002 (n = 36) or BCG Danish strain (n = 12) in a phase II open-labeled, randomized trial with a 6-month follow-up period. Clinical and laboratory measures of safety were evaluated during this time. In addition, vaccine-induced immune responses to mycobacteria were analyzed in whole-blood stimulation and proliferation assays. The safety parameters and immunogenicity were comparable in the two groups. Both vaccines induced interleukin-17 (IL-17) responses; however, VPM1002 vaccination led to an increase of CD8

Indexed as

AbscessBCG VaccineCD8-Positive T-LymphocytesDrug-Related Side Effects and Adverse ReactionsFemaleHumansIncidenceInfant, NewbornMaleSouth AfricaTreatment OutcomeTuberculosisVaccines, SyntheticBCG VaccineVaccines, SyntheticHIV-unexposedIL-17immunogenicitynewbornrecombinantrecombinant BCGsafetyvaccinesVPM1002whole blood assay

Identifiers

PMID27974398
PMCPMC5299117
OpenAlexW2569946142

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.