Evidence map›Paper›PMID 35199165›Full record

Trial reportThe Journal of infectious diseases2023

Neutralizing Antibody Kinetics and Immune Protection Against Herpes Simplex Virus 1 Genital Disease in Vaccinated Women.

Robert B Belshe, Tamara P Blevins, Yinyi Yu, Amanda E Nethington, Abbie Bellamy, Christopher Bryant, Lynda A Morrison

Registry-linked trialOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2023. 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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.3field-weighted citation impact, top 12% 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

8 citing papers in PubMed, 15 citations in OpenAlex.

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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

7 authors at 2 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, USA.
Tamara P BlevinsDepartment of Internal Medicine, Division of Infectious Diseases, Allergy & Immunology, Saint Louis University School of Medicine, St Louis, Missouri, USA.
Yinyi YuDepartment of Internal Medicine, Division of Infectious Diseases, Allergy & Immunology, Saint Louis University School of Medicine, St Louis, Missouri, USA.
Amanda E NethingtonDepartment of Internal Medicine, Division of Infectious Diseases, Allergy & Immunology, Saint Louis University School of Medicine, St Louis, Missouri, USA.
Abbie BellamyThe EMMES Company, Rockville, Maryland, USA.
Christopher BryantThe EMMES Company, Rockville, Maryland, USA.
Lynda A MorrisonDepartment of Internal Medicine, Division of Infectious Diseases, Allergy & Immunology, Saint Louis University School of Medicine, St Louis, Missouri, USA.
Saint Louis University · USEmmes (United States) · US

Funding

CONTROL MEASURES IN AGING AND INFECTIOUS DISEASE-266945250N01AI045250 · NIAID · SAINT LOUIS UNIVERSITY · 1994 to 2003
$0k
NIAID NIH HHS HHSN272201500002CNIAID NIH HHS N01-AI-45250
6 · The paper itself

Abstract

backgroundPreviously, our group conducted the Herpevac Trial for Women, a randomized efficacy field trial of type 2 glycoprotein D (gD2) herpes simplex virus (HSV) vaccine adjuvanted with ASO4 in 8323 women. Study participants were selected to be seronegative for HSV-1 and HSV-2. We found that the vaccine was 82% protective against culture-positive HSV-1 genital disease but offered no significant protection against HSV-2 genital disease. Efficacy against HSV-1 was associated with higher levels of antibody to gD2 at enzyme-linked immunosorbent assay (ELISA).

methodsTo better understand the results of the efficacy study, we measured postvaccination concentrations of neutralizing antibody (nAb) to either HSV-1 and HSV-2 from HSV-infected study participants and matched uninfected controls. Statistical modeling was used to determine whether these responses were correlated with protection against HSV.

resultsnAbs to either HSV-1 or HSV-2 were correlated with ELISA binding antibodies to gD2. HSV-1 or HSV-2 nAb findings support the observation of protection by higher levels of antibody against HSV-1 infection, but the lack of protection against HSV-2 remains unexplained.

conclusionsThe protection against HSV-1 infection observed in the Herpevac Trial for Women was associated with nAbs directed against the virus, although the power to assess this was lower in the nAb study compared with the ELISA results owing to smaller sample size. CLINICAL TRIALS REGISTRATION: NCT00057330.

Indexed as

Genital DiseasesHerpes GenitalisHerpes SimplexHerpesvirus 1, HumanUrogenital DiseasesViral VaccinesAntibodies, NeutralizingAntibodies, ViralFemaleHerpesvirus 2, HumanHumansViral Envelope ProteinsAntibodies, NeutralizingAntibodies, ViralViral Envelope ProteinsViral VaccinesHSV vaccineprotective antibodiesvaccine efficacy

Identifiers

PMID35199165
PMCPMC9927075
OpenAlexW4213222756

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.