Post-Marketing Observational Surveillance Study to Evaluate the Incidence of New-Onset Immune-Mediated Diseases, Herpes Zoster, and Anaphylaxis in Adults 18 Years of Age and Older Who Receive HEPLISAV B® Compared with Another Hepatitis B Vaccine (DV2-HBV-26)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50456
• EU PAS number:
  EUPAS50455
• Study ID:
  50456
• Official title and acronym:
  Post-Marketing Observational Surveillance Study to Evaluate the Incidence of New-Onset Immune-Mediated Diseases, Herpes Zoster, and Anaphylaxis in Adults 18 Years of Age and Older Who Receive HEPLISAV B® Compared with Another Hepatitis B Vaccine (DV2-HBV-26)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The primary objective of this post-marketing observational surveillance study was to describe and compare the incidence of new-onset immune-mediated diseases, herpes zoster, and anaphylaxis in recipients of HEPLISAV B with recipients of another hepatitis B vaccine.
• Study status:
  Finalised

Research institutions and networks

Institutions

Dynavax Technologies

Multiple centres: 15 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 02/04/2018

Study start date

Actual: 07/08/2018

Data analysis start date

Actual: 30/11/2020

Date of final study report

Actual: 23/02/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Dynavax Technologies Corporation

Study protocol

Initial protocol

DV2-HBV-26-protocol-amend-22May18

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)