Vaccine Exposure During PregnancyNCT06097312
PREHEVBRIO Pregnancy Outcomes Registry
An observational study of Vaccine Exposure During Pregnancy, run by VBI Vaccines Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccine Exposure During Pregnancy
- What is being tested?
- Data collection
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2023to 31 Mar 2032
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects participating in another investigational device or drug study product within 28 days prior to conception or at any time during pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
ProPharma, Recruiting Nationwide
Overland Park, Kansas, 66210
About this study
Official title: Prospective, Observational, Non-interventional Study Designed to Detect and Describe Pregnancy Outcomes in Women Exposed to PREHEVBRIO® [Pregnancy Outcomes Registry]
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.
Read the 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.
- Conditions
- Vaccine Exposure During Pregnancy
- Being tested
- Data collection
- Keywords
- PREHEVBRIO, Hepatitis B vaccine, Pregnancy
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Participants | Pregnant women who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of spontaneous abortion
Pregnancy loss <20 weeks of gestation
Measured: 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
Measured: From enrollment until 3 months post-delivery
Secondary outcomes (7)
Rate of pre-term birth
Infant born at gestational age <37 weeks of gestation
Measured: From enrollment until delivery
Rate of term labor
Infant born at gestational age ≥37 weeks of gestation
Measured: From enrollment until delivery
Rate of fetal death/stillbirth
Pregnancy loss ≥20 weeks of gestation
Measured: 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
Voluntary interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health, or due to fetal abnormalities
Measured: From gestation until termination of pregnancy, up to 10 months
Rate of ectopic pregnancy
An ectopic pregnancy occurs when a fertilized egg grows outside of the uterus
Measured: From gestation until termination of pregnancy, up to 10 months
Rate of low birth weight
Infant born with birth weight <2500 g
Measured: From enrollment until delivery
Rate of major congenital abnormalities
Includes transient defects, chromosomal abnormalities, genetic syndromes, and/or positional defects that are prematurity related
Measured: From enrollment until 3 months post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start30 Nov 2023
- Primary completion31 Mar 2032 (estimated)
- Study completion31 Mar 2032 (estimated)
Why it stopped: Company out of business
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Exposure During PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VBI Vaccines Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097312
- Sponsor's protocol ID
- PREHEVBRIO-REGISTRY-US
- Status last verified
- May 2026
- First submitted
- 28 Sep 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Non-interventional Study Designed to Detect and Describe Pregnancy Outcomes in Women Exposed to PREHEVBRIO® [Pregnancy Outcomes Registry]
- ClinicalTrials.gov ID
- NCT06097312
- Acronym / sponsor ID
- PREHEVBRIO-REGISTRY-US
- Conditions
- Vaccine Exposure During Pregnancy
- Keywords
- PREHEVBRIO, Hepatitis B vaccine, Pregnancy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company out of business
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VBI Vaccines Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 31 Mar 2032 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Data collectionPregnant women who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects participating in another investigational device or drug study product within 28 days prior to conception or at any time during pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionThe 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). | Other | Participants |
Primary outcome
Rate of spontaneous abortion
Time frame: Less than 20 weeks of gestation, measured from the day of conception to the day of abortion
Pregnancy loss <20 weeks of gestation
Rate of major congenital malformations
Time frame: From enrollment until 3 months post-delivery
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
7 secondary outcomes
Rate of pre-term birth
Time frame: From enrollment until delivery
Rate of term labor
Time frame: From enrollment until delivery
Rate of fetal death/stillbirth
Time frame: 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
Time frame: From gestation until termination of pregnancy, up to 10 months
Rate of ectopic pregnancy
Time frame: From gestation until termination of pregnancy, up to 10 months
Rate of low birth weight
Time frame: From enrollment until delivery
Rate of major congenital abnormalities
Time frame: From enrollment until 3 months post-delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Exposure During Pregnancy, run by VBI Vaccines Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of spontaneous abortion (time frame: Less than 20 weeks of gestation, measured from the day of conception to the day of abortion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.