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A Study of the Immune Response to Heplisav in Healthy Older Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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.

NCT01999699•Dynavax Technologies Corporation

View on ClinicalTrials.gov

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.

Detailed Description

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

Eligibility

Age

50 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Johnson County Clinical Trials

Lenexa, Kansas, United States

Key Dates

Start Date

November 1, 2013

Primary Completion Date

February 1, 2015

Completion Date

March 1, 2015

Last Updated

March 20, 2019

Enrollment

ACTUAL participants

Conditions

Hepatitis B

Interventions

HEPLISAV

BIOLOGICAL

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

NCT07024641

Hepatitis B Virus Infection

View study

RECRUITINGPHASE1

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series