Post-Marketing Observational Surveillance Study to Evaluate the Occurrence of Acute Myocardial Infarction in Adults 18 Years of Age and Older Who Receive HEPLISAV-B® Compared with Another Hepatitis B Vaccine (DV2-HBV-25)

Study identification

• EU PAS number:
  EUPAS50452
• Study ID:
  50453
• Official title and acronym:
  Post-Marketing Observational Surveillance Study to Evaluate the Occurrence of Acute Myocardial Infarction in Adults 18 Years of Age and Older Who Receive HEPLISAV-B® Compared with Another Hepatitis B Vaccine (DV2-HBV-25)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The primary objective of this observational surveillance study was to compare the occurrence of confirmed acute myocardial infarction (AMI) in recipients of HEPLISAV-B and recipients of another hepatitis B vaccine. For the final study analysis, potential AMI events were abstracted from electronic health record (EHR) and redacted of hepatitis B vaccination information. The primary analyses were based on confirmed type 1 AMI events using a Cox proportional hazards model employing inverse probability of treatment weighting (IPTW) to compare rates between the two vaccine groups.
• 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: 03/01/2018

Study start date

Actual: 07/08/2018

Data analysis start date

Actual: 30/11/2020

Date of final study report

Actual: 29/11/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Dynavax Technologies Corporation

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)