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What is the difference between Heplisav-B and Engerix-B?

Answers (1)

Official Answer by Drugs.com 23 Jan 2018

Heplisav-B is the only two-dose hepatitis B vaccine approved for adults. Heplisav-B and Engerix-B are both recombinant hepatitis B vaccines given by intramuscular (IM) injection, but Heplisav-B, approved in November 2017, contains an adjuvant, an agent that can help to boost the immune response to the vaccine. Heplisav-B combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Engerix-B does not contain an adjuvant.

Can Heplisav-B be used in children?

Heplisav-B is only approved for prevention of hepatitis B virus in adults age 18 years and older. Engerix-B is used in both pediatrics, starting with infants at birth, and adults.

How is Heplisav-B given?

Most current hepatitis B vaccines require three shots over a six-month period, however, almost half of adults fail to complete the series within one year. With Heplisav-B, a two-dose series given one month apart may help to increase the vaccine completion rates.

How does Heplisav-B compare to Engerix-B?

Higher rates of effectiveness in adults were shown with Heplisav-B vaccine. In Phase III studies, Heplisav-B was administered in two doses over one month and compared to Engerix-B administered in three doses over a six-month schedule. Heplisav-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B. In a subgroup analysis in Type 2 diabetes, Heplisav-B demonstrated a statistically significantly higher rate of protection of 90% compared to 65% for Engerix-B in these patients.

Do the side effects with Heplisav-B differ from Engerix-B?

Side effects appear to be similar between the two vaccines. Across the three clinical trials with Heplisav-B, the most common side effects were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%). With Engerix-B, common side effects included injection-site soreness (22%), fatigue (14%), headache, and dizziness (1% to 10%).

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