Evidence map›Paper›PMID 18784341›Full record

Trial reportClinical and vaccine immunology : CVI2008

Phase I study of a herpes simplex virus type 2 (HSV-2) DNA vaccine administered to healthy, HSV-2-seronegative adults by a needle-free injection system.

Ashok Cattamanchi, Christine M Posavad, Anna Wald, Yaela Baine, Jennifer Moses, Terry J Higgins, Richard Ginsberg, Richard Ciccarelli, Lawrence Corey, David M Koelle

Open access · diamondAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
2.6field-weighted citation impact, top 11% 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

32 citing papers in PubMed, 64 citations in OpenAlex.

  1. Trial
  2. Review
  3. Efficacy of traditional herb aqua extract ofIranian journal of microbiology · 2024
    Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article
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

10 authors at 3 institutions in 1 country.

Ashok CattamanchiDepartment of Medicine, University of Washington, Seattle, WA 98109, USA.
Christine M Posavad
Anna Wald
Yaela Baine
Jennifer Moses
Terry J Higgins
Richard Ginsberg
Richard Ciccarelli
Lawrence Corey
David M Koelle
University of Washington · USHuman Immunome Project · USFred Hutch Cancer Center · US

Funding

INSTITUTE FOR TRANSLATIONAL HEALTH SCIENCE (UL1): BPCAUL1RR025014 · NCRR · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2007 to 2011
$51.5M
THE PERINATAL COMPLICATIONS OF ASYMPTOMATIC GENITAL HERPES SIMPLEX VIRUSP01AI030731 · NIAID · UNIVERSITY OF WASHINGTON · PI WALD, ANNA · 1991 to 2017
$34.3M
Clinical Research in HSV InfectionsK24AI071113 · NIAID · UNIVERSITY OF WASHINGTON · PI WALD, ANNA · 2006 to 2015
$1.7M
Immune Correlates of HSV-2 Disease SeverityR01AI050132 · NIAID · UNIVERSITY OF WASHINGTON · PI KOELLE, DAVID M · 2003 to 2007
$1.3M
Immune Correlates of HSV-2 Disease SeverityR21AI050132 · NIAID · UNIVERSITY OF WASHINGTON · PI KOELLE, DAVID M · 2001 to 2001
$260k
NCRR NIH HHS UL1 RR025014NIAID NIH HHS AI030731NIAID NIH HHS AI50132NIAID NIH HHS K24 AI071113NIAID NIH HHS K24-AI071113NIAID NIH HHS P01 AI030731NIAID NIH HHS R01 AI050132NIAID NIH HHS R21 AI050132
6 · The paper itself

Abstract

We conducted a double-blind, vehicle-controlled, dose escalation safety and immunogenicity trial of a candidate herpes simplex virus type 2 (HSV-2) surface glycoprotein D2 (gD2) DNA vaccine administered by use of a needle-free device. Sixty-two healthy adults were randomized using a 4:1 vaccine-to-placebo ratio. Half of the participants were HSV-1 seronegative, and all were HSV-2 seronegative. Vaccine doses included 100 microg, 300 microg, 1,000 microg or 3,000 microg of a plasmid expressing the gD2 protein. Subjects received vaccine at 0, 4, 8, and 24 weeks. Some subjects received an additional 1,000-microg boost at 52 weeks. We found that the vaccine was safe and well tolerated, with most adverse events being local site reactions. No dose-limiting toxicities were observed. gD2-specific cytotoxic T-lymphocyte and lymphoproliferation responses were detected 2 weeks after the third vaccine injection in one of four HSV-1-seronegative, HSV-2-seronegative participants who received 3,000 microg of vaccine. A DNA-based vaccination strategy against HSV-2 appears to be safe and may generate a vaccine-specific cellular immune response, but high vaccine doses are likely needed to elicit an immune response in most vaccinees.

Indexed as

AdultCell ProliferationCytotoxicity Tests, ImmunologicDouble-Blind MethodFemaleHerpes Simplex Virus VaccinesHerpesvirus 2, HumanHumansImmunization, SecondaryInjectionsMaleMiddle AgedPlacebosPlasmidsT-Lymphocytes, CytotoxicVaccinationglycoprotein D-herpes simplex virus type 2Herpes Simplex Virus VaccinesPlacebosVaccines, DNAViral Envelope Proteins

Identifiers

PMID18784341
PMCPMC2583522
OpenAlexW2097160969

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.