Dynavax Announces Final Immunogenicity and Interim Safety Results from Clinical Trial Evaluating HEPLISAV-B in Patients Undergoing Hemodialysis
Final immunogenicity data in 119 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) undergoing hemodialysis, demonstrated a seroprotection rate of 89.3% with high levels of anti-HBs antibodies, which are critical to maintain protection in patients undergoing hemodialysis. Interim safety data showed HEPLISAV-B is well tolerated and no safety concerns were observed. Full safety data are expected by the end of 2021.
"We are pleased with these positive results from the ongoing hemodialysis trial which reinforce the existing clinical data regarding the safety and ability of HEPLISAV-B to provide high rates of protection," commented
The study, HBV-24, is an ongoing, open-label, single-arm trial being conducted in
Please see Important Safety Information below.
For more information about HEPLISAV-B, visit http://heplisavb.com
About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person.
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with
Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
Important Safety Information (ISI)
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% to 39%), fatigue (11% to 17%) and headache (8% to 17%).
For full Prescribing Information for HEPLISAV-B, click here
This press release contains forward-looking statements, including statements regarding use of HEPLISAV-B in adults undergoing hemodialysis. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether and when the clinical study will be completed and what the final results will reflect, and whether additional studies will be required to demonstrate safety and effectiveness of HEPLISAV-B in person's undergoing hemodialysis, and if further studies are required, when they would be completed and what the results will reflect. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Dynavax in general, see risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC
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i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.
iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.
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