Evidence map›Paper›PMID 28472067›Full record

Trial reportPLoS neglected tropical diseases2017

The effect of current Schistosoma mansoni infection on the immunogenicity of a candidate TB vaccine, MVA85A, in BCG-vaccinated adolescents: An open-label trial.

Anne Wajja, Dennison Kizito, Beatrice Nassanga, Angela Nalwoga, Joyce Kabagenyi, Simon Kimuda, Ronald Galiwango, Gertrude Mutonyi, Samantha Vermaak, Iman Satti and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in PLoS neglected tropical 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 NCT02178748 (A Phase II Open Label Trial to Investigate the Effect of Schistosoma Mansoni), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT02178748 phase2completednot on this map

A Phase II Open Label Trial to Investigate the Effect of Schistosoma Mansoni (Sm) Infection on the Immunogenicity of a Candidate TB Vaccine, MVA85A, in BCG-vaccinated African Adolescents

TypeinterventionalSponsorUniversity of OxfordRan2014 to 2015Enrolled36ConditionsTuberculosisArmsMVA85A
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. MVA85A vaccine to enhance BCG for preventing tuberculosis.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. What's Old and New in Tuberculosis Vaccines for Children.Journal of the Pediatric Infectious Diseases Society · 2022
    Article
  10. Review
  11. Article
  12. Immunological Considerations forFrontiers in immunology · 2021
    Review
  13. Article
  14. Review
  15. Article
  16. CD4 T Cells inFrontiers in immunology · 2020
    Article
  17. Article
  18. Article
  19. Article
  20. 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

17 authors at 6 institutions in 4 countries.

Anne WajjaCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.ORCID http://orcid.org/0000-0003-1711-4218
Dennison KizitoCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Beatrice NassangaCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Angela NalwogaCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Joyce KabagenyiCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Simon KimudaCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Ronald GaliwangoCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Gertrude MutonyiCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Samantha VermaakThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Iman SattiThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Jaco VerweijLaboratory for Medical Microbiology and Immunology & Laboratory for Clinical Pathology, St. Elisabeth Hospital, Tilburg, The Netherlands.
Edridah TukahebwaVector Control Division, Ministry of Health, Kampala, Uganda.
Stephen CoseCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Jonathan LevinCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Pontiano KaleebuCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Alison M ElliottCo-infection Studies Program, MRC/UVRI Uganda Research Unit, Entebbe, Uganda.
Helen McShaneThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Uganda Virus Research Institute · UGUniversity of Oxford · GBLondon School of Hygiene & Tropical Medicine · GBElisabeth-TweeSteden Ziekenhuis · NLMinistry of Health · UGUniversity of the Witwatersrand · ZA

Funding

Wellcome Trust
6 · The paper itself

Abstract

introductionHelminth infection may affect vaccine immunogenicity and efficacy. Adolescents, a target population for tuberculosis booster vaccines, often have a high helminth burden. We investigated effects of Schistosoma mansoni (Sm) on the immunogenicity and safety of MVA85A, a model candidate tuberculosis vaccine, in BCG-vaccinated Ugandan adolescents.

methodsIn this phase II open label trial we enrolled 36 healthy, previously BCG-vaccinated adolescents, 18 with no helminth infection detected, 18 with Sm only. The primary outcome was immunogenicity measured by Ag85A-specific interferon gamma ELISpot assay. Tuberculosis and schistosome-specific responses were also assessed by whole-blood stimulation and multiplex cytokine assay, and by antibody ELISAs.

resultsAg85A-specific cellular responses increased significantly following immunisation but with no differences between the two groups. Sm infection was associated with higher pre-immunisation Ag85A-specific IgG4 but with no change in antibody levels following immunisation. There were no serious adverse events. Most reactogenicity events were of mild or moderate severity and resolved quickly.

conclusionsThe significant Ag85A-specific T cell responses and lack of difference between Sm-infected and uninfected participants is encouraging for tuberculosis vaccine development. The implications of pre-existing Ag85A-specific IgG4 antibodies for protective immunity against tuberculosis among those infected with Sm are not known. MVA85A was safe in this population.

trial registrationClinicalTrials.gov NCT02178748.

Indexed as

Immunogenicity, VaccineAcyltransferasesAdolescentAnimalsAntibodies, BacterialAntigens, BacterialBCG VaccineChildFemaleHumansImmunity, CellularImmunoglobulin GLinear ModelsMaleSchistosoma mansoniSchistosomiasis mansoniAcyltransferasesAntibodies, Bacterialantigen 85A, Mycobacterium tuberculosisAntigens, BacterialBCG VaccineImmunoglobulin GMVA 85ATuberculosis VaccinesVaccines, DNA

Identifiers

PMID28472067
PMCPMC5417418
OpenAlexW2610167931

What OpenQuestion holds

Textmetadata
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.