Evidence map›Paper›PMID 26657184›Full record

Trial reportVaccine2016

Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls: A randomized clinical trial.

David I Bernstein, Flor M Munoz, S Todd Callahan, Richard Rupp, Susan H Wootton, Kathryn M Edwards, Christine B Turley, Lawrence R Stanberry, Shital M Patel, Monica M Mcneal and 3 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 146 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
146citing papers in PubMed, 3 pooled it
11.8field-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

146 citing papers in PubMed, 3 syntheses or guidelines pooled it, 232 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Cytomegalovirus Genetic Diversity Following Primary Infection.The Journal of infectious diseases · 2020
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. HCMV glycoprotein B subunit vaccine efficacy mediated by nonneutralizing antibody effector functions.Proceedings of the National Academy of Sciences of the United States of America · 2018
    Trial
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Observational
  20. Review

86 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 9 institutions in 2 countries.

David I BernsteinCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, United States. Electronic address: David.Bernstein@cchmc.org.
Flor M MunozBaylor College of Medicine, Houston, TX, United States.
S Todd CallahanVanderbilt University Medical Center, Nashville, TN, United States.
Richard RuppUniversity of Texas Medical Branch at Galveston, Galveston, TX, United States.
Susan H WoottonUniversity of Texas Health Science Center at Houston, Houston, TX, United States.
Kathryn M EdwardsVanderbilt University Medical Center, Nashville, TN, United States.
Christine B TurleyUniversity of Texas Medical Branch at Galveston, Galveston, TX, United States; University of South Carolina School of Medicine, Columbia, SC, United States.
Lawrence R StanberryUniversity of Texas Medical Branch at Galveston, Galveston, TX, United States; Columbia University, New York Presbyterian Hospital, New York City, NY, United States.
Shital M PatelBaylor College of Medicine, Houston, TX, United States.
Monica M McnealCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, United States.
Sylvie PichonSanofi Pasteur, Marcy L'Etoile, France.
Cyrille AmegashieThe Emmes Corporation, Rockville, MD, United States.
Abbie R BellamyThe Emmes Corporation, Rockville, MD, United States.
Baylor College of Medicine · USEmmes (United States) · USThe University of Texas Medical Branch at Galveston · USVanderbilt University Medical Center · USCincinnati Children's Hospital Medical Center · USNewYork–Presbyterian Hospital · USSanofi (France) · FRThe University of Texas Health Science Center at Houston · USUniversity of Cincinnati · US

Funding

VANDERBILT UNIVERSITY CTSA FOR PEDIATRIC RESEARCHUL1RR024975 · NCRR · VANDERBILT UNIVERSITY · PI BERNARD, GORDON RAPHAEL · 2007 to 2011
$45.7M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
CTSA: K12 COMPONENTKL2RR024149 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2011
$6.7M
NCATS NIH HHS UL1 TR000371NCRR NIH HHS 3KL2RR024149-05S1NCRR NIH HHS KL2 RR024149NCRR NIH HHS UL1 RR024975NCRR NIH HHS UL1 RR024975-01NIAID NIH HHS HHSN272200800002CNIAID NIH HHS HHSN272200800006CNIAID NIH HHS HHSN272200800013CNIAID NIH HHS N01 AI080006PHS HHS HHSN27220080000C
6 · The paper itself

Abstract

backgroundCytomegalovirus (CMV) is a leading cause of congenital infection and an important target for vaccine development.

methodsCMV seronegative girls between 12 and 17 years of age received CMV glycoprotein B (gB) vaccine with MF59 or saline placebo at 0, 1 and 6 months. Blood and urine were collected throughout the study for evidence of CMV infection based on PCR and/or seroconversion to non-vaccine CMV antigens.

results402 CMV seronegative subjects were vaccinated (195 vaccine, 207 placebo). The vaccine was generally well tolerated, although local and systemic adverse events were significantly more common in the vaccine group. The vaccine induced gB antibody in all vaccine recipients with a gB geometric mean titer of 13,400 EU; 95%CI 11,436, 15,700, after 3 doses. Overall, 48 CMV infections were detected (21 vaccine, 27 placebo). In the per protocol population (124 vaccine, 125 placebo) vaccine efficacy was 43%; 95%CI: -36; 76, p=0.20. The most significant difference was after 2 doses, administered as per protocol; vaccine efficacy 45%, 95%CI: -9; 72, p=0.08.

conclusionThe vaccine was safe and immunogenic. Although the efficacy did not reach conventional levels of significance, the results are consistent with a previous study in adult women (Pass et al. N Engl J Med 2009;360:1191) using the same formulation.

Indexed as

Adjuvants, ImmunologicAdolescentAntibodies, ViralAntigens, ViralBloodChildCytomegalovirus InfectionsCytomegalovirus VaccinesDNA, ViralDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunization SchedulePlacebosPolymerase Chain ReactionAdjuvants, ImmunologicAntibodies, ViralAntigens, ViralCytomegalovirus VaccinesDNA, Viralglycoprotein B, SimplexvirusMF59 oil emulsionPlacebosPolysorbatesSqualeneVaccines, SubunitVaccines, SyntheticViral Envelope ProteinsAdolescentCMV gBCytomegalovirusVaccine

Identifiers

PMID26657184
PMCPMC4701617
OpenAlexW2186253039

What OpenQuestion holds

Textmetadata
LicenceTDM
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.