Evidence map›Paper›PMID 22837094›Full record

Trial reportClinical and vaccine immunology : CVI2012

Phase IIa study of the immunogenicity and safety of the novel Staphylococcus aureus vaccine V710 in adults with end-stage renal disease receiving hemodialysis.

Moustafa Moustafa, George R Aronoff, Chandra Chandran, Jonathan S Hartzel, Steven S Smugar, Claude M Galphin, Lionel U Mailloux, Elizabeth Brown, Mark J Dinubile, Nicholas A Kartsonis and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00572910 (A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Merck Staphylococcus Aureus Vaccine), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00572910 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Merck Staphylococcus Aureus Vaccine (V710) in Adult Patients With End-Stage Renal Disease on Chronic Hemodialysis

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2008 to 2010Enrolled206ConditionsStaphylococcus Aureus InfectionArmsComparator: Placebo (PBO), V710 Comparator: Placebo (PBO)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. A promisingClinical and experimental vaccine research · 2025
    Review
  4. Article
  5. Review
  6. Antimicrobial resistance in nephrology.Nature reviews. Nephrology · 2019
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Vaccines for the 21st century.EMBO molecular medicine · 2014
    Review
  15. Review
  16. 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

11 authors.

Moustafa MoustafaSouth Carolina Nephrology & Hypertension Center, Orangeburg, SC, USA.
George R Aronoff
Chandra Chandran
Jonathan S Hartzel
Steven S Smugar
Claude M Galphin
Lionel U Mailloux
Elizabeth Brown
Mark J Dinubile
Nicholas A Kartsonis
Dalya Guris

Funding

U OF TEXAS HLTH SCI CTR HOUSTON CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCESUL1RR024148 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2010
$27.9M
NCRR NIH HHS UL1 RR024148
6 · The paper itself

Abstract

Bacteremia is the second leading cause of death in patients with end-stage renal disease who are on hemodialysis. A vaccine eliciting long-term immune responses against Staphylococcus aureus in patients on chronic hemodialysis may reduce the incidence of bacteremia and its complications in these patients. V710 is a vaccine containing iron surface determinant B (IsdB), a highly conserved S. aureus surface protein, which has been shown to be immunogenic in healthy subjects. In this blinded phase II immunogenicity study, 206 chronic hemodialysis patients between the ages of 18 and 80 years old were randomized to receive 60 μg V710 (with or without adjuvant), 90 μg V710 (with adjuvant), or a placebo in various combinations on days 1, 28, and 180. All 201 vaccinated patients were to be followed through day 360. The primary hypothesis was that at least 1 of the 3 groups receiving 2 V710 doses on days 1 and 28 would have a ≥2.5 geometric mean fold rise (GMFR) in anti-IsdB IgG titers over the baseline 28 days after the second vaccination (day 56). At day 56, all three groups receiving 2 doses of V710 achieved a ≥2.5 GMFR in anti-IsdB antibodies compared to the baseline (P values of <0.001 for all 3 groups), satisfying the primary immunogenicity hypothesis. None of the 33 reported serious adverse experiences were considered vaccine related by the investigators. V710 induced sustained antibody responses for at least 1 year postvaccination in patients on chronic hemodialysis.

Indexed as

Renal DialysisAdolescentAdultAgedAged, 80 and overBacteremiaCation Transport ProteinsDouble-Blind MethodFemaleHumansKidney Failure, ChronicMaleMiddle AgedPlacebosStaphylococcal InfectionsStaphylococcal VaccinesCation Transport ProteinsIsdB protein, Staphylococcus aureusPlacebosStaphylococcal Vaccines

Identifiers

PMID22837094
PMCPMC3428394

What OpenQuestion holds

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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.