Evidence map›Paper›PMID 24285844›Full record

Trial reportThe Journal of infectious diseases2014

Correlate of immune protection against HSV-1 genital disease in vaccinated women.

Robert B Belshe, Thomas C Heineman, David I Bernstein, Abbie R Bellamy, Marian Ewell, Robbert van der Most, Carolyn D Deal

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00057330 (A Double-Blind, Randomized, Controlled Phase III Study to Assess the Prophylactic Efficacy and Safety of gD-Alum/MPL Vaccine in the Prevention of Genital Herpes Disease in Young Women Who Are HSV-1 and -2 Seronegative), which is not on this map. Cited by 80 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 1 pooled it
7.1field-weighted citation impact, top 2% 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.

NCT00057330 phase3completednot on this map

A Double-Blind, Randomized, Controlled Phase III Study to Assess the Prophylactic Efficacy and Safety of gD-Alum/MPL Vaccine in the Prevention of Genital Herpes Disease in Young Women Who Are HSV-1 and -2 Seronegative

TypeinterventionalSponsorGlaxoSmithKlineRan2003 to 2009Enrolled8,323ConditionsHerpes Simplex InfectionArmsHSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine, Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 1 synthesis or guideline pooled it, 113 citations in OpenAlex.

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  11. Vaccine and Treatment Evaluation Units: A Historical Perspective.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Robert B BelsheDepartment of Internal Medicine, Division of Infectious Diseases, Allergy & Immunology, Saint Louis University School of Medicine, St. Louis, Missouri 63104, USA.
Thomas C Heineman
David I Bernstein
Abbie R Bellamy
Marian Ewell
Robbert van der Most
Carolyn D Deal
Emmes (United States) · USGlaxoSmithKline (United States) · USCincinnati Children's Hospital Medical Center · USNational Institutes of Health · USSaint Louis University · US

Funding

CONTROL MEASURES IN AGING AND INFECTIOUS DISEASE-266945250N01AI045250 · NIAID · SAINT LOUIS UNIVERSITY · 1994 to 2003
$0k
NIAID NIH HHS N01 AI045250NIAID NIH HHS N01-AI-45250
6 · The paper itself

Abstract

backgroundPreviously we conducted a double-blind controlled, randomized efficacy field trial of gD-2 HSV vaccine adjuvanted with ASO4 in 8323 women. Subjects had been previously selected to be seronegative for HSV-1 and HSV-2. We found that vaccine was 82% protective against HSV-1 genital disease, but offered no significant protection against HSV-2 genital disease.

methodsTo better understand the results of the efficacy study, post-vaccination anti-gD-2 antibody concentrations from all HSV infected subjects and matched uninfected controls were measured. Three models were used to determine whether thes responses correlated with protection against HSV infection or disease. Similarly, cellular immune responses from a subset of subjects and matched controls were evaluated for a correlation with HSV protection.

resultsAntibodies to gD-2 correlated with protection against HSV-1 infection with higher antibody concentration associated with higher efficacy. Cellular immune responses to gD-2 did not correlate with protection.

conclusionsThe protection against HSV-1 infection observed in the Herpevac Trial for Women was associated with antibodies directed against the vaccine. Clinical Trials Registration NCT00057330.

Indexed as

Antibodies, ViralCase-Control StudiesCytokinesDouble-Blind MethodEnzyme-Linked Immunosorbent AssayFemaleHerpes GenitalisHerpes Simplex Virus VaccinesHerpesvirus 1, HumanHumansProspective StudiesAntibodies, ViralCytokinesHerpes Simplex Virus VaccinesHSV vaccineprotective antibodiesvaccine efficacy

Identifiers

PMID24285844
PMCPMC3935479
OpenAlexW2150685651

What OpenQuestion holds

Textmetadata
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.