Evidence map›Paper›PMID 29982727›Full record

Trial reportThe Journal of infectious diseases2018

Effects of Different Doses of GEN-003, a Therapeutic Vaccine for Genital Herpes Simplex Virus-2, on Viral Shedding and Lesions: Results of a Randomized Placebo-Controlled Trial.

Nicholas Van Wagoner, Kenneth Fife, Peter A Leone, David I Bernstein, Terri Warren, Lori Panther, Richard M Novak, Richard Beigi, John Kriesel, Stephen Tyring and 8 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
3.2field-weighted citation impact, top 8% 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

27 citing papers in PubMed, 47 citations in OpenAlex.

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  19. Alphaherpesvirus Vaccines.Current issues in molecular biology · 2021
    Review
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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

18 authors at 13 institutions in 1 country.

Nicholas Van WagonerDivision of Infectious Diseases, University of Alabama at Birmingham.
Kenneth FifeDepartment of Medicine, Indiana University, Indianapolis.
Peter A LeoneDepartment of Medicine, University of North Carolina, Chapel Hill.
David I BernsteinDivision of Infectious Diseases, Cincinnati Children's Hospital, Cincinnati.
Terri WarrenWestover Heights Clinic, Portland, Oregon.
Lori PantherDepartment of Internal Medicine, Beth Israel Deaconess Hospital, Boston, Massachusetts.
Richard M NovakDivision of Infectious Diseases, University of Illinois, Chicago.
Richard BeigiDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh.
John KrieselDepartment of Internal Medicine, University of Utah, Salt Lake City.
Stephen TyringCenter for Clinical Studies, University of Texas Health Science Center; Houston.
William KoltunMedical Center for Clinical Research, San Diego, California.
Gregg LucksingerTekton Research, Austin, Texas.
Amy MorrisIND 2 Results, Atlanta, Georgia.
Bin ZhangGenocea Biosciences, Cambridge, Massachusetts.
Lisa K McNeilGenocea Biosciences, Cambridge, Massachusetts.
Sybil TaskerGenocea Biosciences, Cambridge, Massachusetts.
Seth HetheringtonGenocea Biosciences, Cambridge, Massachusetts.
Anna WaldDepartment of Medicine, University of Washington Fred Hutchinson Cancer Research Center, Seattle, Washington.
Genocea (United States) · USBeth Israel Deaconess Hospital · USCenter for Clinical Research (United States) · USCenter for Clinical Studies · USCincinnati Children's Hospital Medical Center · USIndiana University – Purdue University Indianapolis · USUniversity of Alabama at Birmingham · USUniversity of Illinois Chicago · USUniversity of North Carolina at Chapel Hill · USUniversity of Pittsburgh · USUniversity of Utah · USUniversity of Washington · USWestover Heights Clinic · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
NIAID NIH HHS P30 AI050410
6 · The paper itself

Abstract

Background: GEN-003 is a candidate therapeutic vaccine for genital herpes simplex virus type 2 (HSV-2). We compared virologic and clinical impact of varying GEN-003 doses. Methods: Adults with symptomatic HSV-2 received placebo or GEN-003 (30 or 60 µg antigen with 25, 50, or 75 µg adjuvant). Viral shedding and lesion rates before vaccination were compared with those measured immediately after vaccination, then at weeks 29-33 and 53-57 after last dose. Results: Compared with baseline shedding rates, the rate ratios for viral shedding immediately after treatment were as follows: 0.82 (95% confidence interval [CI], 0.49-1.36), 30 µg antigen/25 µg adjuvant (30/25) dose; 0.64 (95% CI, 0.45-0.92), 30/50 dose; 0.63 (95% CI, 0.37-1.10), 30/75 dose; 0.56 (95% CI, 0.36-0.88), 60/25 dose; 0.58 (95% CI, 0.38-0.89), 60/50 dose; 0.45 (95% CI, 0.16-0.79), 60/75 dose; and 0.98 (95% CI, 0.76-1.26), placebo. Lesion rate reductions by GEN-003 ranged from 31% to 69%, but lesion rates also decreased among placebo recipients (62%). Reductions in shedding and lesion rate were durable for 12 months for the 60 µg antigen plus 50 or 75 µg adjuvant groups. No serious adverse events occurred with vaccination. Conclusions: The most efficacious vaccine combinations for GEN-003 were the 60 µg/50 µg and 60 µg/75 µg doses.

Indexed as

ImmunotherapyAdjuvants, ImmunologicAdolescentAdultFemaleHerpes GenitalisHerpesvirus 2, HumanHumansMaleMiddle AgedVaccinationViral VaccinesVirus SheddingYoung AdultAdjuvants, ImmunologicViral Vaccines

Identifiers

PMID29982727
PMCPMC7191615
OpenAlexW2839822882

What OpenQuestion holds

Textmetadata
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.