Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers

Hepatitis B Clinical Trial

Official title:

Effects of Persistent Innate Immune Activation on Vaccine Efficacy Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055365
• Other study ID #: BRO-0828
• Status: Completed
• Phase: N/A
• Start date: February 18, 2014
• Est. completion date: January 6, 2015

Study information

• Verified date: April 2018
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity.This study aims to define cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.

Description:

Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity. Knowledge of those genes and cellular functions activated by effective vaccination can improve our understanding of how the immune system works and define the features necessary for a successful vaccine response. This study aims to define cellular functions important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators will identify those genes that are activated or suppressed in immune cells at various times after each dose of the HBV vaccine. The investigators will explore these vaccine-induced "gene signatures" to characterize the cellular functions associated with an effective immune response to HBV vaccination. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 6, 2015
• Est. primary completion date: January 6, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy volunteer without significant medical problems

• Willing to receive three doses of an FDA-approved Hepatitis B vaccine

Exclusion Criteria:

• Male or female < 18 and > 60 years of age

• Received any vaccine within a month prior to study vaccine

• History of Hepatitis B infection

• History of previous Hepatitis B vaccination(s)

• History of Hepatitis C virus (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

• Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen

• human immunodeficiency virus (HIV) positive

• 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

• Is pregnant or lactating

• 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 30 weeks

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Biological:
• Hepatitis B Vaccine (Recombinant)
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).

Locations

Country	Name	City	State
United States	The Rockefeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).	Number of differentially expressed genes at time point versus prevaccination baseline (p<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.	Day 1, Day 3, Week 1, and Week 2
Primary	Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).	Number of significantly differentially expressed genes at time point versus prevaccination baseline (FDR<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.	Day 1, Day 3, Week 1, and Week 2