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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02055365
Other study ID # BRO-0828
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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