PREHEVBRIO Vaccine Exposure for Pregnancy Outcomes

Overseen By Francisco Diaz-Mitoma, MD, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: VBI Vaccines Inc.

Must be taking: Hepatitis B vaccine

Disqualifiers: Other investigational studies

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding the effects of the PREHEVBRIO® hepatitis B vaccine when administered during pregnancy. Researchers collect information from women who received the vaccine shortly before or during pregnancy to monitor potential impacts on both mother and baby. The trial aims to identify any safety concerns related to vaccine use during this period. Women who received this vaccine just before or during pregnancy and agree to share their medical information are suitable participants for this study. As a Phase 4 trial, this research provides valuable insights into the safety of the already FDA-approved vaccine during pregnancy, helping to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring outcomes for those exposed to the PREHEVBRIO vaccine during pregnancy.

What prior data suggests that the PREHEVBRIO® vaccine is safe for pregnant women?

Research shows that there is insufficient information about how the PREHEVBRIO vaccine affects pregnant women. Scientists are still learning about any possible risks to pregnancy or the baby. Current studies aim to gather more details on these effects.

While the vaccine prevents hepatitis B, its impact during pregnancy is still under careful observation. Prospective participants should know that the main goal is to assess how the vaccine affects pregnancy and newborns. This information will help ensure safety for mothers and babies in the future. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for preventing hepatitis B during pregnancy involve established vaccines like Engerix-B, Recombivax HB, or HEPLISAV-B. However, PREHEVBRIO® is unique because it uses a three-antigen formulation, which may offer broader immune protection compared to the single-antigen vaccines commonly used. Researchers are excited about PREHEVBRIO® because it could potentially provide enhanced immunity for pregnant women and their babies, reducing the risk of hepatitis B transmission. This distinctive approach might offer a new level of safety and efficacy for expecting mothers and their newborns.

What evidence suggests that the PREHEVBRIO® vaccine is safe for pregnant women?

Research shows limited information about how the PREHEVBRIO® vaccine works during pregnancy. This vaccine is approved for preventing hepatitis B in adults, confirming its effectiveness for that purpose. However, its effects on pregnancy require further study. In this trial, participants are pregnant women who received the PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy. The researchers aim to observe and understand how the vaccine affects pregnant women and their babies. This study will provide more insight into its safety and effects during pregnancy. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Inclusion Criteria

A pregnant woman who received the PREHEVBRIO® vaccine within 28 days before her estimated date of delivery (EDD), or at any time during pregnancy, is eligible for this registry

The subject has consented to the release of medical information and communication with her healthcare providers, as well as any infant's provider, for gathering such data.

The contact details of the reporter (participant and/or healthcare provider) are accessible to facilitate subsequent communication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Pregnant women are enrolled in the registry after exposure to PREHEVBRIO®

Ongoing

Observation

Participants are monitored for pregnancy and fetal outcomes from enrollment until 3 months post-delivery or early termination

Up to 13 months

Follow-up

Participants are monitored for safety and effectiveness after delivery

3 months post-delivery

What Are the Treatments Tested in This Trial?

Interventions

• PREHEVBRIO

How Is the Trial Designed?

Group I: Participants Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

VBI Vaccines Inc.

Lead Sponsor

Trials

12

Recruited

5,700+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06097312?cond=Prenatal%20Exposure%20OR%20Exposure%20During%20Pregnancy%20OR%20Teratogenesis&aggFilters=status:not%20rec&rank=2

PREHEVBRIO Pregnancy Outcomes Registry

The purpose of the registry is to detect, describe, and evaluate adverse pregnancy outcomes in females exposed to PREHEVBRIO® within 28 days prior to conception ...

2.

cdc.gov

cdc.gov/acip/evidence-to-recommendations/prehevbrio-hepb-etr.html

ACIP Evidence to Recommendations for use of PreHevbrio ...

Available human data on PreHevbrio administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are ...

3.

fda.gov

fda.gov/media/154561/download

Package Insert - PREHEVBRIO

There are no adequate and well-controlled studies of PREHEVBRIO in pregnant women. Available human data on PREHEVBRIO administered to pregnant women are ...

4.

prehevbrio.com

prehevbrio.com/

PreHevbrio Hepatitis B Vaccine (Recombinant) – VBI Vaccines

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. ... vaccine groups. CONSTANT ...

5.

vbivaccines.com

vbivaccines.com/prehevbrio/

Our Product

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age ...