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Effects of Persistent Innate Immune Activation on Vaccine Efficacy

NCT02429583 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-03-04

Study results available
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Summary

This study will investigate the effects of chronic HCV infection and corresponding innate immune activation on the immune response to HBV vaccination. We will recruit chronic HCV patients and healthy control patients for HBV vaccination. We will use RNA Sequencing (RNA-Seq), a relatively new technology for simultaneously measuring the expression of all genes, to determine patients' innate immune status, and learn how this innate immune signature is related to HBV vaccine response. We will then explore the mechanisms by which chronic HCV infection affects different immune cells and functions that are known to be important for an effective HBV vaccine response. These studies will enhance our understanding of the immune effects of chronic viral infection, establish factors that determine effective vaccine responses, and help guide vaccination strategies for HCV patients and other individuals with chronic inflammatory disease.

Conditions

  • Hepatitis C Infection

Interventions

DRUG

Recombivax

Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Charles Rice, PhD · The Rockefeller University Center for Clinical and Translational

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
62 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-08
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02429583 on ClinicalTrials.gov