DV2-HBV-27: Observational Pregnancy Registry

Active, not recruiting

• Conditions: Pregnant
• Interventions: Biological: HEPLISAV-B

• Registration Number: NCT03664648
• Lead Sponsor: Dynavax Technologies Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-10
• Study Start: 2021-02-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult Pregnant Women Exposed to HEPLISAV-B	HEPLISAV-B	Adult women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

PPD Registry Office, Recruiting Nationwide; 🇺🇸 Wilmington, North Carolina, United States