N/A
N=10
Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT02055365 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction). — 138; 138; 102; 81 number of genes at p<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hepatitis B Vaccine (Recombinant) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rockefeller University
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction). |
138; 138; 102; 81; 11139; 11318 | — |
| PRIMARY Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing). |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02055365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.