Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine

D

Dynavax Technologies Corporation

Status and phase

Completed
Phase 2

Conditions

Hepatitis B

Treatments

Biological: HEPLISAV

Study type

Interventional

Funder types

Industry

Identifiers

NCT00511095
DV2-HBV-14

Details and patient eligibility

About

The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.

Full description

This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity. Comparison: This study does not include a control treatment; all subjects will receive treatment with HEPLISAV™.

Enrollment

207 patients

Sex

All

Ages

11 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Willing and able to give written informed consent
  • Women of childbearing potential must be willing to consistently use a highly effective method of birth control

Exclusion criteria

  • Women who are pregnant or breastfeeding
  • Any previous HBV infection
  • Previous vaccination (1 or more doses) with any HBV vaccine
  • Any previous autoimmune diseases
  • Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
  • Received any blood products or antibodies within 3 months prior to study entry
  • Ever received an injection with DNA plasmids or oligonucleotides
  • Received any vaccines within 4 weeks prior to study entry
  • Received any other investigational medicinal agent within 4 weeks prior to study entry

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

207 participants in 1 patient group

HEPLISAV
Experimental group
Description:
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Intramuscular (IM) injection 0.5mL
Treatment:
Biological: HEPLISAV

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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