Clinical trial NCT06097312: PREHEVBRIO Pregnancy Outcomes Registry
Official title: Prospective, Observational, Non-interventional Study Designed to Detect and Describe Pregnancy Outcomes in Women Exposed to PREHEVBRIO® [Pregnancy Outcomes Registry]
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaccine Exposure During Pregnancy
Keywords: PREHEVBRIO
Hepatitis B vaccine
Pregnancy
Lead sponsor: VBI Vaccines Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-24
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: VBI Vaccines was granted a Biologic License by the FDA on 30 November 2021, to introduce PREHEVBRIO® in the United States for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The vaccine has also been approved in the United Kingdom, Europe, Canada, and Israel, and is currently marketed in the United States, United Kingdom, the Netherlands, Belgium, and Israel.

According to the American College of Obstetricians and Gynecologists, pregnant women who are negative for hepatitis B virus infection and who are at risk for hepatitis B virus infection should be specifically targeted for hepatitis B vaccination. However, more data is required to make such a recommendation for PREHEVBRIO®. The rationale to conduct this study, include: (1) PREHEVBRIO®, as a newly licensed vaccine in the U.S., is not indicated for pregnant women; (2) pregnant women were actively excluded from trials during clinical development of PREHEVBRIO®; and (3) there have only been limited human data to inform the safety of PREHEVBRIO® administered during pregnancy. Since PREHEVBRIO® vaccination is not indicated in pregnancy, exposure to PREHEVBRIO® in pregnancy is likely to be inadvertent and to occur in early pregnancy.

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 or at any time during pregnancy and to detect adverse fetal and/or neonatal outcomes at delivery or early termination.

The registry is strictly observational; schedule of office visits and all treatment regimens will be determined by the treating health care provider; no additional laboratory tests or assessments are required as part of this registry; only data noted as part of routine care will be collected. Subjects will be followed from enrollment until 3 months post-delivery or early termination of pregnancy.

Pregnant women will be enrolled in the registry prospectively (after exposure to the product but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). If the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. Retrospective reports are also eligible for the registry, but they will be analyzed separately from prospective reports. The analyses of study data will primarily use descriptive and inferential statistical methods designed to detect potential safety signals, rather than test hypotheses.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Rate of spontaneous abortion
timeFrame: Less than 20 weeks of gestation, measured from the day of conception to the day of abortion
measure: Rate of major congenital malformations
timeFrame: From enrollment until 3 months post-delivery
Secondary outcomes:
measure: Rate of pre-term birth
timeFrame: From enrollment until delivery
measure: Rate of term labor
timeFrame: From enrollment until delivery
measure: Rate of fetal death/stillbirth
timeFrame: 20 or more weeks of gestation, measured from the day of conception to the day of fetal death/stillbirth, up to 10 months
measure: Rate of induced abortion
timeFrame: From gestation until termination of pregnancy, up to 10 months
measure: Rate of ectopic pregnancy
timeFrame: From gestation until termination of pregnancy, up to 10 months
measure: Rate of low birth weight
timeFrame: From enrollment until delivery
measure: Rate of major congenital abnormalities
timeFrame: From enrollment until 3 months post-delivery
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: ProPharma, Recruiting Nationwide
state: Kansas
Study officials:
References: