PregnantHBV-27NCT03664648
DV2-HBV-27: Observational Pregnancy Registry
An observational study of Pregnant, run by Dynavax Technologies Corporation at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant
- What is being tested?
- HEPLISAV-B
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2021to Dec 2024
- How long will I take part?
- 12 Months
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women 18 years of age or older exposed to HEPLISAV-B within 28 days of conception or at any time during pregnancy.
Who may be able to join
- 18 years and older
- HEPLISAV-B exposure within 28 days prior to conception or at any time during pregnancy
Who cannot join
- Less than 18 years of age
- HEPLISAV-B exposure greater than 28 days prior to conception
Trial locations and contacts
1 site in 1 country.
United States1 site
PPD Registry Office, Recruiting Nationwide
Wilmington, North Carolina, 28401
About this study
Official title: HEPLISAV-B Pregnancy Registry: An Observational Study on the Safety of HEPLISAV-B Exposure in Pregnant Women and Their Offspring
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
- Conditions
- Pregnant
- Being tested
- HEPLISAV-B
- Keywords
- Pregnant, Conceived, HBV Vaccine, Hepatitis B, Hepatitis B vaccine, HBV, Hepatitis, Registry, Prevention, Female volunteers
- Medical subject headings
- Hepatitis B, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPLISAV-BBiological
This study is strictly observational. Administration of HEPLISAV-B, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Adult Pregnant Women Exposed to HEPLISAV-B | Adult women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy. Receives: Biological: HEPLISAV-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Congenital Malformations in Live-Born Infants.
Measured: 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
Measured: Follow-up will end at the time of pregnancy outcome up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start21 Feb 2021
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnantStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD, Part of Thermo Fisher Scientific
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664648
- Sponsor's protocol ID
- DV2-HBV-27
- Acronym
- HBV-27
- Status last verified
- Sep 2023
- First submitted
- 18 Jul 2018
- Last updated
- 18 Sep 2023
- 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 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEPLISAV-B Pregnancy Registry: An Observational Study on the Safety of HEPLISAV-B Exposure in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT03664648
- Acronym / sponsor ID
- HBV-27 / DV2-HBV-27
- Conditions
- Pregnant
- Keywords
- Pregnant, Conceived, HBV Vaccine, Hepatitis B, Hepatitis B vaccine, HBV, Hepatitis, Registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Collaborators
- PPD, Part of Thermo Fisher Scientific
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Sep 2018 (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.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Pregnant Women Exposed to HEPLISAV-B | – | Biological: HEPLISAV-BAdult women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women 18 years of age or older exposed to HEPLISAV-B within 28 days of conception or at any time during pregnancy.
Key inclusion criteria (2 listed)
- 18 years and older
- HEPLISAV-B exposure within 28 days prior to conception or at any time during pregnancy
Key exclusion criteria (2 listed)
- Less than 18 years of age
- HEPLISAV-B exposure greater than 28 days prior to conception
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 |
|---|---|---|
| HEPLISAV-BThis study is strictly observational. Administration of HEPLISAV-B, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care. | Biological | Adult Pregnant Women Exposed to HEPLISAV-B |
Primary outcome
Rate of Major Congenital Malformations in Live-Born Infants.
Time frame: 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
Time frame: Follow-up will end at the time of pregnancy outcome up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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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 Pregnant, run by Dynavax Technologies Corporation 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. 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?
Results are not available in the source record.
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 Major Congenital Malformations in Live-Born Infants. (time frame: Live-born infants will be followed to 12 months of age). 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 18 Sep 2023.