Evidence map›Paper›PMID 20619382›Full record

Trial reportVaccine2010

Safety and immunogenicity of HCV E1E2 vaccine adjuvanted with MF59 administered to healthy adults.

Sharon E Frey, Michael Houghton, Stephen Coates, Sergio Abrignani, David Chien, Domenico Rosa, Piero Pileri, Ranjit Ray, Adrian M Di Bisceglie, Paola Rinella and 6 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 138 papers.

0numbers the graph read from it
0cells of the map it votes in
138citing papers in PubMed
7.8field-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.

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

138 citing papers in PubMed, 248 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Nanocarrier-based immunotherapy for viral diseases.International journal of pharmaceutics: X · 2025
    Review
  7. Review
  8. Hepatitis C virus modifiedJournal of virology · 2025
    Article
  9. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Article
  19. Hepatitis C virus modified sE2Journal of virology · 2024
    Article
  20. Review

78 more citing papers are in PubMed but not listed here.

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

16 authors at 7 institutions in 5 countries.

Sharon E FreySaint Louis University School of Medicine, Division of Infectious Diseases and Immunology, St. Louis, MO 63104, USA. freyse@slu.edu
Michael Houghton
Stephen Coates
Sergio Abrignani
David Chien
Domenico Rosa
Piero Pileri
Ranjit Ray
Adrian M Di Bisceglie
Paola Rinella
Heather Hill
Mark C Wolff
Viola Schultze
Jang H Han
Bruce Scharschmidt
Robert B Belshe
Saint Louis University · USNovartis (Switzerland) · CHEmmes (United States) · USIstituto Nazionale Genetica Molecolare · ITNovartis (Germany) · DERapt Therapeutics (United States) · USUniversity of Alberta · CA

Funding

EVALUATION OF CONTROL MEASURES AGAINST DISEASES OTHER THAN AIDS-266025464N01AI025464 · NIAID · SAINT LOUIS UNIVERSITY · PI CHAPLESKI, ELIZABETH · 2003 to 2006
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NIAID NIH HHS N01 AI025464NIAID NIH HHS N01-AI-25464
6 · The paper itself

Abstract

backgroundHepatitis C virus (HCV) causes chronic liver disease that often leads to cirrhosis and hepatocellular carcinoma. In animal studies, chimpanzees were protected against chronic infection following experimental challenge with either homologous or heterologous HCV genotype 1a strains which predominate in the USA and Canada. We describe the first in humans clinical trial of this prophylactic HCV vaccine.

methodsHCV E1E2 adjuvanted with MF59C.1 (an oil-in-water emulsion) was given at 3 different dosages on day 0 and weeks 4, 24 and 48 in a phase 1, placebo-controlled, dose escalation trial to healthy HCV-negative adults.

resultsThere was no significant difference in the proportion of subjects reporting adverse events across the groups. Following vaccination subjects developed antibodies detectable by ELISA, CD81 neutralization and VSV/HCV pseudotype neutralization. There were no significant differences between vaccine groups in the number of responders and geometric mean titers for each of the three assays. All subjects developed lymphocyte proliferation responses to E1E2 and an inverse response to increasing amounts of antigen was noted.

conclusionsThe vaccine was safe and generally well-tolerated at each of the 3 dosage levels and induced antibody and lymphoproliferative responses. A larger study to further evaluate safety and immunogenicity is warranted.

Indexed as

Adjuvants, ImmunologicAdultAntibodies, NeutralizingCD4-Positive T-LymphocytesCell ProliferationDouble-Blind MethodFemaleHepacivirusHepatitis AntibodiesHepatitis CHumansImmunization ScheduleMaleMiddle AgedPolysorbatesSqualeneAdjuvants, ImmunologicAntibodies, NeutralizingHepatitis AntibodiesMF59 oil emulsionPolysorbatesSqualeneViral Hepatitis Vaccines

Identifiers

PMID20619382
PMCPMC2923449
OpenAlexW1963707175

What OpenQuestion holds

Textmetadata
LicenceTDM
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.