PREHEVBRIO Pregnancy Outcomes Registry

NCT06097312 | Recruiting DMC FDA Drug

• 1 other identifier: PREHEVBRIO-REGISTRY-US
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The registry is an observational surveillance program designed to recruit and encourage participation of women who were exposed to PREHEVBRIO® hepatitis B vaccine during pregnancy and to collect and analyze information related to post-exposure pregnancy and fetal and neonatal outcomes. The objective of the Registry is to monitor and evaluate all received reports of PREHEVBRIO® vaccine exposure within 28 days prior to conception or at any time during pregnancy and delivery, as well as maternal, obstetrical, pregnancy, fetal and neonatal outcomes. This registry is primarily descriptive and designed to detect potential safety signals rather than test hypotheses.

Conditions

Vaccine Exposure During Pregnancy

Keywords

PREHEVBRIO; Hepatitis B vaccine; Pregnancy

Outcome Measures

Primary Outcomes (2)

• Rate of spontaneous abortion

  Pregnancy loss \<20 weeks of gestation

  Less than 20 weeks of gestation, measured from the day of conception to the day of abortion

• Rate of major congenital malformations

  Major structural or genetic birth defects, including conditions that (1) result from a malformation, deformation, or disruption in one or more parts of the body, a chromosomal abnormality, or a known clinical syndrome; (2) are present at birth; and (3) have a serious, adverse effect on health, development, or functional ability

  From enrollment until 3 months post-delivery

Secondary Outcomes (7)

• Rate of pre-term birth

  From enrollment until delivery

• Rate of term labor

  From enrollment until delivery

• Rate of fetal death/stillbirth

  20 or more weeks of gestation, measured from the day of conception to the day of fetal death/stillbirth, up to 10 months

• Rate of induced abortion

  From gestation until termination of pregnancy, up to 10 months

• Rate of ectopic pregnancy

  From gestation until termination of pregnancy, up to 10 months

Study Arms (1)

Participants

Pregnant women who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy.

Other: Data collection

Interventions

Data collection OTHER

The schedule of office visits and all treatment regimens will be determined by the treating health care provider. No interventions are administered as part of this protocol (observational study).

Participants

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy are eligible for inclusion. Because the vaccine is not indicated in pregnancy, the majority of exposures are likely to be inadvertently administered during the first trimester of pregnancy.

You may qualify if:

• Pregnant woman who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy. The time of conception will be calculated as the most reliable estimated date of delivery (EDD) minus 38 weeks. For this registry, gestational weeks will be estimated from the EDD or as corrected EDD, if a more reliable EDD (e.g., by ultrasound) is provided. If the EDD is not available or never estimated, the first day of the last menstrual period (LMP) will be used to estimate gestational age and EDD.
• The subject provided consent prior to enrollment (for eligible subjects under 18 years old, consent must be obtained from the subject's legally authorized representative).
• The subject documents agreement with the release of medical information and contact with her healthcare providers (e.g., PCP, obstetrician, nurse midwife) and the infant's healthcare provider (e.g., pediatrician) for the purpose of collecting medical information.
• Reporter's (participant and/or healthcare provider) contact information is available to allow for follow up.

You may not qualify if:

• Subjects participating in another investigational device or drug study product within 28 days prior to conception or at any time during pregnancy.

Sponsors & Collaborators

• VBI Vaccines Inc.: lead

Study Sites (1)

ProPharma, Recruiting Nationwide

Overland Park, Kansas, 66210, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Project Manager

CONTACT

888-421-8808; medinfo@vbivaccines.com

Francisco Diaz-Mitoma, MD, PhD

CONTACT

613-729-4200; fdiazmitoma@vbivaccines.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 24, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): March 31, 2032
• Study Completion (Estimated): March 31, 2032
• Last Updated: December 8, 2023

Record last verified: 2023-11

Locations

US (1)