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Completed

NCT Number: NCT01999699

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johnson County Clinical Trials

Lenexa, Kansas, 66219, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEPLISAV

Biological

Primary outcomes

  1. Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.

    Time frame: Day 1, 3, and 7 and on Day 28

  2. 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).

    Time frame: Day 1, 3, and 7 and on Day 28

Sponsors and collaborators

Lead sponsor

Dynavax Technologies Corporation

Industry

Collaborators

  • Baylor Research Institute

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2013
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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