Dynavax | Heplisav-B Pregnancy Registry

Why enroll in the HEPLISAV-B Pregnancy Registry?

We encourage you to voluntarily enroll in the HEPLISAV-B Pregnancy Registry and help us learn more about the health of infants born to mothers who were vaccinated with HEPLISAV-B within 28 days prior to conception or during pregnancy. Your participation may help other women and their babies in the future.

What is required of me to participate?

You must be at least 18 years of age.
You must currently be pregnant, or have already delivered and your infant has been diagnosed with a birth defect.
You must have received a dose of the hepatitis B vaccine HEPLISAV-B within 28 days prior to conception or during your pregnancy. You will not be vaccinated as part of the study.
You must agree to provide Personal and Healthcare Provider contact information and consent for release of medical information for yourself and your infant. Once enrolled we will collect all necessary information from you and your infant’s respective healthcare providers.

Is it easy to enroll in the Registry?

Yes, there are three simple ways to contact the Registry staff.

Telephone number: Toll-free 1-844-443-7734
Email address: heplisavbpregnancyregistry@ppdi.com
Download the Participant Consent to Contact Card, fill it out and send it to us via email or fax( 1-877-202-3940 ).

Ways to enroll in the HEPLISAV-B® Pregnancy Registry

Call our toll-free number

1-844-443-7734

Submit an email to

heplisavbpregnancyregistry@ppdi.com

Download

Participant Consent to Contact Card

(Fill it out and send it to us via email or fax (1-877-202-3940))

INDICATION

HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

IMPORTANT SAFETY INFORMATION

Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).

References: 1. HEPLISAV-B [package insert]. Emeryville, CA: Dynavax Technologies Corporation; 2020.2. Dynavax’s HEPLISAV-B^® [Hepatitis B Vaccine (Recombinant), Adjuvanted] Recommended by CDC Advisory Committee on Immunization Practices for the Prevention of Hepatitis B in Adults [news release]. Emeryville, CA: Dynavax Technologies Corporation. http://investors.dynavax.com/news-releases/newsrelease-details/dynavaxs-heplisav-btm-hepatitis-b-vaccine-recombinant-adjuvanted. Accessed March 15, 2018.

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