Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
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|ClinicalTrials.gov Identifier: NCT02117934|
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : January 10, 2018
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: HEPLISAV Biological: Engerix-B||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8374 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
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.
Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
Active Comparator: Engerix-B
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.
Intramuscular injections at Week 0, Week 4, and Week 24
Other Name: Hepatitis B vaccine (recombinant)
- Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest [ Time Frame: Week 56 ]The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.
- Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response [ Time Frame: Week 28 ]Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117934
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|Study Director:||Robert Janssen, MD||Dynavax Technologies Corporation|