Evidence map›Paper›PMID 25131726›Full record

ArticleVaccine2014

Assessing the feasibility of hepatitis C virus vaccine trials: results from the Hepatitis C Incidence and Transmission Study-community (HITS-c) vaccine preparedness study.

Bethany White, Annie Madden, Maria Prins, Margaret Hellard, Handan Wand, Gregory J Dore, Kimberly Page, Lisa Maher

Open access · greenAbstract read
In one paragraph

Article in Vaccine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 26% 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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Challenges and Promise of a Hepatitis C Virus Vaccine.Cold Spring Harbor perspectives in medicine · 2020
    Review
  7. Article
  8. Review
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  10. Article
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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

8 authors at 3 institutions in 2 countries.

Bethany WhiteThe Kirby Institute, UNSW Australia, Sydney, NSW 2052, Australia.
Annie MaddenAustralian Injecting & Illicit Drug Users League (AIVL), Sydney Building, Level 2/112-116 Alinga Street, Canberra ACT 2600, Australia.
Maria PrinsAcademic Medical Centre, Center for Infection and Immunity Amsterdam (CINIMA), University of Amsterdam, The Netherlands; Cluster of Infectious Diseases, Department of Research, Public Health Service, Amsterdam, The Netherlands.
Margaret HellardCentre for Population Health, The Macfarlane Burnet Institute for Medical Research, 85 Commercial Road, Melbourne, Victoria 3004, Australia.
Handan WandThe Kirby Institute, UNSW Australia, Sydney, NSW 2052, Australia.
Gregory J DoreThe Kirby Institute, UNSW Australia, Sydney, NSW 2052, Australia.
Kimberly PageDepartment of Epidemiology and Biostatistics, University of California San Francisco, 50 Beale Street, Suite 1200, San Francisco, CA 94105, USA.
Lisa MaherThe Kirby Institute, UNSW Australia, Sydney, NSW 2052, Australia. Electronic address: lmaher@kirby.unsw.edu.au.
Australian Plague Locust Commission · AUBurnet Institute · AUUniversity of California, San Francisco · US

Funding

UCSF Liver Core CenterP30DK026743 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Holger Willenbring · 1986 to 2026
$30.7M
Acute Hepatitis C Infection in Young InjectorsR01DA016017 · NIDA · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI PAGE, KIMBERLY · 2002 to 2018
$14.0M
International Collaborative of prospective studies of HIV and Hepatitis in IDUR01DA031056 · NIDA · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI PAGE, KIMBERLY · 2011 to 2015
$2.2M
NIDA NIH HHS R01 DA016017NIDA NIH HHS R01DA016017NIDA NIH HHS R01 DA031056NIDA NIH HHS R01DA031056NIDDK NIH HHS P30 DK026743PHS HHS HHSN2662040074C NIAID STI/CTG
6 · The paper itself

Abstract

Efficacy trials of preventive hepatitis C virus (HCV) vaccine candidates raise challenging scientific and ethical issues. Based on data from the first 3 years of a community-based prospective observational study - the Hepatitis C Incidence and Transmission Study-community (HITS-c) - this paper examines the feasibility of conducting trials of candidate HCV vaccines with people who inject drugs (PWID) in Sydney, Australia. Of the 166 PWID confirmed HCV antibody negative and eligible for enrolment, 156 (94%) completed baseline procedures. Retention was high, with 89% of participants retained at 48 weeks and 76% of participants completing at least 75% of study visits within 2 weeks of schedule. The rate of primary HCV infection was 7.9/100 py (95% CI 4.9, 12.7). Of the 17 incident cases, 16 completed at least one follow-up assessment and 12 (75%) had evidence of chronic viraemia with progression to chronic HCV infection estimated to be 6/100 py. Power calculations suggest a chronic HCV infection rate of at least 12/100 py (primary HCV infection rate 16/100 py) will be required for stand-alone trials of highly efficacious candidates designed to prevent chronic infection. However, elevated primary HCV infection was observed among participants not receiving opioid substitution therapy who reported heroin as the main drug injected (26.9/100 py, 95% CI 14.5, 50.0) and those who reported unstable housing (23.5/100 py, 95% CI 7.6, 72.8), daily or more frequent injecting (22.7/100 py, 95% CI 12.2, 42.2) and receptive syringe sharing (23.6/100 py, 95% CI 9.8, 56.7) in the 6 months prior to baseline. These data suggest that it is possible to recruit and retain at-risk PWID who adhere to study protocols and that modification of eligibility criteria may identify populations with sufficiently high HCV incidence. Results support the feasibility of large multi-centre HCV vaccine trials, including in the Australian setting.

Indexed as

Research DesignAdultAustraliaFeasibility StudiesFemaleHepatitis CHepatitis C AntibodiesHumansIncidenceMalePatient CompliancePatient DropoutsPatient SelectionRisk-TakingSample SizeSubstance Abuse, IntravenousHepatitis C AntibodiesViral Hepatitis VaccinesHepatitis C virusPeople who inject drugsVaccine preparedness study

Identifiers

PMID25131726
PMCPMC4509604
OpenAlexW2053263959

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.