Evidence map›Paper›PMID 37579209›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Controlled Human Infection Model for Hepatitis C Virus Vaccine Development: Trial Design Considerations.

Jordan J Feld, Julie Bruneau, Gregory J Dore, Marc G Ghany, Bettina Hansen, Mark Sulkowski, David L Thomas

Open access · bronzeAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
6.7field-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

10 citing papers in PubMed, 33 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. [Progress on the research of liver diseases in 2023].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
    Article
  7. Review
  8. Article
  9. Immunological Monitoring in Hepatitis C Virus Controlled Human Infection Model.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  10. Challenge Inoculum for Hepatitis C Virus Controlled Human Infection Model.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    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

7 authors at 6 institutions in 4 countries.

Jordan J FeldToronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Canada.ORCID 0000-0003-2640-2211
Julie BruneauCentre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Université de Montréal, Montreal, Canada.
Gregory J DoreKirby Institute, University of New South Wales, Sydney, Australia.
Marc G GhanyLiver Diseases Branch, National Institutes of Diabetes, Digestive, and Kidney Diseases, Bethesda, Maryland, USA.
Bettina HansenDepartment of Medicine, Erasmus University, Rotterdam, The Netherlands.
Mark SulkowskiDepartment of Medicine, The Johns Hopkins University, Baltimore, Maryland, USA.
David L ThomasDepartment of Medicine, The Johns Hopkins University, Baltimore, Maryland, USA.
Johns Hopkins University · USCentre Hospitalier de l’Université de Montréal · CAErasmus University Rotterdam · NLNational Institute of Diabetes and Digestive and Kidney Diseases · USUniversity Health Network · CAUNSW Sydney · AU

Funding

Elimination of HCV and related liver disease among HIV-infected and -uninfected people who inject drugsR01DA048063 · NIDA · JOHNS HOPKINS UNIVERSITY · PI Shruti H Mehta, David L Thomas · 2019 to 2026
$4.2M
Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
NIDA NIH HHS K24 DA034621NIDA NIH HHS R01 DA048063
6 · The paper itself

Abstract

The design of a clinical trial for a controlled human infection model (CHIM) to accelerate hepatitis C virus (HCV) vaccine development requires careful consideration. The design of a potential approach to HCV CHIM is outlined, involving initial sentinel cohorts to establish the safety and curability of the viral inoculum followed by larger cohorts to establish the spontaneous clearance rate for each inoculum. The primary endpoint would be HCV clearance by 24 weeks post-inoculation, recognizing that the prevention of chronic infection would be the primary goal of HCV vaccine candidates. Additional considerations are discussed, including the populations to be enrolled, the required monitoring approach, indications for antiviral therapy, and the required sample size for different CHIM approaches. Finally, safety considerations for CHIM participants are discussed.

Indexed as

Hepatitis CHepatitis C, ChronicVaccinesAntiviral AgentsHepacivirusHumansSample SizeAntiviral AgentsVaccineschallenge modelcontrolled human infection modelhepatitis C virustrial designvaccine

Identifiers

PMID37579209
PMCPMC10425135
OpenAlexW4385802459

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.