A Study of the Immune Response to Heplisav in Healthy Older Adults

Hepatitis B Clinical Trial

Official title:

A Phase 1 Systems Biology Study to Investigate Immune Correlates of the Response to an Experimental Hepatitis B Vaccine (HEPLISAV) in Healthy Adults 50 to 70 Years of Age.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999699
• Other study ID #: DV2-HBV-22
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2019
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the response of the immune system to a hepatitis B (HB) vaccine in healthy adults 50 to 70 years of age. This study is partially funded by the National Institute of Allergy and Infectious Diseases.

Description:

The purpose of this study is to examine how the immune system responds to vaccination with HEPLISAV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• 50 to 70 years of age, inclusive

• In good health in the opinion of the principal investigator, based upon medical history and physical examination

• Serum negative for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)

• If female of childbearing potential, agree to consistently use a highly effective method of birth control from the screening visit through Week 12/Visit 10

Exclusion Criteria:

• Pregnant, breastfeeding, or planning a pregnancy

• Known history of an autoimmune disease

• Previously received any hepatitis B vaccine (approved or investigational)

• Body-mass index (BMI) >30 kg/m2, diabetes mellitus (type 1 or 2), or other chronic medical condition that in the opinion of the principal investigator might interfere with the immune response to hepatitis B vaccination

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Biological:
• HEPLISAV

Locations

Country	Name	City	State
United States	Johnson County Clinical Trials	Lenexa	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation	Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.		Day 1, 3, and 7 and on Day 28
Primary	Determine which of these changes correlate with the development of protective levels of antibody (anti-HBs >/= 10 milli-international unit (mIU)/mL) to hepatitis B virus (HBV).		Day 1, 3, and 7 and on Day 28

External Links

•   Link