Evidence map›Paper›PMID 31735553›Full record

ArticleEBioMedicine2019

Seronegative patients vaccinated with cytomegalovirus gB-MF59 vaccine have evidence of neutralising antibody responses against gB early post-transplantation.

Ilona Baraniak, Ariane C Gomes, Isabella Sodi, Toby Langstone, Emily Rothwell, Claire Atkinson, Sylvie Pichon, Fabienne Piras-Douce, Paul D Griffiths, Matthew B Reeves

Open access · goldAbstract read
In one paragraph

Article in EBioMedicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
1.3field-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

18 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Insight for Immunotherapy of HCMV Infection.International journal of biological sciences · 2021
    Review
  15. Article
  16. Article
  17. Review
  18. 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

10 authors at 2 institutions in 2 countries.

Ilona BaraniakInstitute for Immunity and Transplantation, UCL, Royal Free Campus, London NW3 2PF, United Kingdom.
Ariane C GomesInstitute for Immunity and Transplantation, UCL, Royal Free Campus, London NW3 2PF, United Kingdom.
Isabella SodiInstitute for Immunity and Transplantation, UCL, Royal Free Campus, London NW3 2PF, United Kingdom.
Toby LangstoneInstitute for Immunity and Transplantation, UCL, Royal Free Campus, London NW3 2PF, United Kingdom.
Emily RothwellInstitute for Immunity and Transplantation, UCL, Royal Free Campus, London NW3 2PF, United Kingdom.
Claire AtkinsonInstitute for Immunity and Transplantation, UCL, Royal Free Campus, London NW3 2PF, United Kingdom.
Sylvie PichonClinical Development, Sanofi Pasteur, Marcy l'Etoile, France.
Fabienne Piras-DouceResearch and Non-Clinical Safety, Sanofi Pasteur, Marcy l'Etoile, France.
Paul D GriffithsInstitute for Immunity and Transplantation, UCL, Royal Free Campus, London NW3 2PF, United Kingdom.
Matthew B ReevesInstitute for Immunity and Transplantation, UCL, Royal Free Campus, London NW3 2PF, United Kingdom. Electronic address: matthew.reeves@ucl.ac.uk.
The Royal Free Hospital · GBSanofi (France) · FR

Funding

PHASE IB TRIAL OF CYTOMEGALOVIRUS GLYCOPROTEIN B VACCINER01AI051355 · NIAID · UNIVERSITY COLLEGE LONDON · PI GRIFFITHS, PAUL D · 2003 to 2008
$866k
NIAID NIH HHS R01 AI051355Wellcome Trust
6 · The paper itself

Abstract

backgroundHuman cytomegalovirus (HCMV) causes a ubiquitous infection which can pose a significant threat for immunocompromised individuals, such as those undergoing solid organ transplant (SOT). Arguably, the most successful vaccine studied to date is the recombinant glycoprotein-B (gB) with MF59 adjuvant which, in 3 Phase II trials, demonstrated 43-50% efficacy in preventing HCMV acquisition in seronegative healthy women or adolescents and reduction in virological parameters after SOT. However, the mechanism of vaccine protection in seronegative recipients remains undefined.

methodsWe evaluated samples from the cohort of seronegative SOT patients enroled in the Phase II glycoprotein-B/MF59 vaccine trial who received organs from seropositive donors. Samples after SOT (0-90 days) were tested by real-time quantitative PCR for HCMV DNA. Anti-gB antibody levels were measured by ELISA. Neutralization was measured as a decrease in infectivity for fibroblast cell cultures revealed by expression of immediate-early antigens.

findingsSerological analyses revealed a more rapid increase in the humoral response against gB post transplant in vaccine recipients than in those randomised to receive placebo. Importantly, a number of patient sera displayed HCMV neutralising responses - neutralisation which was abrogated by pre-absorbing the sera with recombinant gB.

interpretationWe hypothesise that the vaccine primed the immune system of seronegative recipients which, when further challenged with virus at time of transplant, allowed the host to mount rapid immunological humoral responses even under conditions of T cell immune suppression during transplantation.

Indexed as

PolysorbatesSqualeneAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, ViralClinical Trials, Phase II as TopicCytomegalovirusCytomegalovirus InfectionsEnzyme-Linked Immunosorbent AssayHumansImmunization, SecondaryImmunocompromised HostNeutralization TestsOrgan TransplantationRandomized Controlled Trials as TopicTime FactorsAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, Viralglycoprotein B, SimplexvirusMF59 oil emulsionPolysorbatesSqualeneViral Envelope ProteinsViral VaccinesAntibody responsesCytomegalovirusPrime-boostVaccination

Identifiers

PMID31735553
PMCPMC6921368
OpenAlexW2987432919

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.