HEPLISAV-B® Pregnancy Registry: an observational study on the safety of HEPLISAV-B exposure in pregnant women and their offspring (DV2-HBV-27)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50523
• EU PAS number:
  EUPAS50522
• Study ID:
  50523
• Official title and acronym:
  HEPLISAV-B® Pregnancy Registry: an observational study on the safety of HEPLISAV-B exposure in pregnant women and their offspring (DV2-HBV-27)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The objective of the HEPLISAV-B® Pregnancy Registry is to evaluate pregnancy outcomes among women who received a dose of the HEPLISAV-B vaccine within 28 days prior to conception or at any time during pregnancy. This registry is primarily descriptive and designed to detect potential safety signals rather than test hypotheses. This study is strictly observational. Administration of HEPLISAV-B, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Dynavax Technologies

Study timelines

Date when funding contract was signed

Actual: 18/12/2017

Study start date

Actual: 11/06/2021

Data analysis start date

Planned: 01/12/2023

Date of final study report

Planned: 31/12/2023

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)