Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

Dynavax Technologies Corporation

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Biological: HEPLISAV; Biological: Engerix-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117934

DV2-HBV-23

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.

Enrollment: 8,374 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

A subject must meet all of the following criteria to be eligible for the trial:

Inclusion Criteria:

• Be 18-70 years of age, inclusive
• Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
• If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week 28.
• Able and willing to provide informed consent

A subject with any one of the following criteria is not eligible for the trial:

Exclusion Criteria:

• Previous receipt of any hepatitis B vaccine

• History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV

• History of autoimmune disorder

• History of sensitivity to any component of study vaccines

• Has received the following prior to the first injection:

  1. Within 28 days:

     • Any vaccine
     • Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
     • Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
     • Any other investigational medicinal agent

  2. Within 90 days: Blood products or immunoglobulin

  3. At any time: An injection of DNA plasmids or oligonucleotide

• If female: Pregnant, nursing, or planning to become pregnant during the trial

• Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin

• Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8,374 participants in 2 patient groups

HEPLISAV

Experimental group

Description:

0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV.

Treatment:

Biological: HEPLISAV

Engerix-B

Active Comparator group

Description:

1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of Engerix-B.

Treatment:

Biological: Engerix-B