Effects of Persistent Innate Immune Activation on Vaccine Efficacy

Stopped early · Phase 4

Conditions studied: Hepatitis C Infection

In brief

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.

Key facts

Study ID

NCT02429583

Run by

Rockefeller University

People needed

24

Starts

2015-05-08

Expected to finish

2018-11-01

Last updated by the study team

2020-03-04

Who can join

Age: 18 and older, up to 62. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Willing to receive three doses of an FDA-approved Hepatitis B vaccine
• Volunteer chronically infected with HCV (as demonstrated by serology and/or viral load laboratory studies)
• Healthy volunteer without significant medical problems

You may not qualify if…

• Received any vaccine within a month prior to study vaccine
• Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
• HIV positive
• For HCV-negative, healthy volunteers: History of HCV infection or positive HCV antibody test
• Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
• In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
• Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease (in addition to HCV infection, for HCV group)
• Currently taking systemic steroids or other immunomodulatory medications including anticancer medications and antiviral medications
• Any clinically significant acute or chronic medical condition requiring care by a primary care provider (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation
• Unable to continue participation for 156 weeks
• History of previous Hepatitis B vaccination(s)
• Male or female < 18 and > 62 years of age
• Is pregnant or lactating
• History of Hepatitis B infection
• Clinical, laboratory, or biopsy evidence of cirrhosis

Where it is running

• Rockefeller University Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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