DV2-HBV-27: Observational Pregnancy Registry

HEPLISAV-B Pregnancy Registry: An Observational Study on the Safety of HEPLISAV-B Exposure in Pregnant Women and Their Offspring

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03664648

Acronym

HBV-27

Enrollment

300

Registered

2018-09-10

Start date

2021-02-21

Completion date

2024-12-31

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant

Keywords

Pregnant, Conceived, HBV Vaccine, Hepatitis B, Hepatitis B vaccine, HBV, Hepatitis, Registry, Prevention, Female volunteers

Brief summary

Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy

Interventions

BIOLOGICALHEPLISAV-B

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 design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 18 years and older * HEPLISAV-B exposure within 28 days prior to conception or at any time during pregnancy

Exclusion criteria

* Less than 18 years of age * HEPLISAV-B exposure greater than 28 days prior to conception

Design outcomes

Primary

Measure	Time frame
Rate of Major Congenital Malformations in Live-Born Infants.	Live-born infants will be followed to 12 months of age
Rate of Still Births, Pre-Term, or Fetal Loss (Including Spontaneous Abortion) of any Gestational Age	Follow-up will end at the time of pregnancy outcome up to 9 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026