NIH Record - National Institutes of Health

Hepatitis B Vaccine Regimen Protects People with HIV

A three-dose course of the hepatitis B vaccine HEPLISAV-B fully protected adults living with HIV who had never been vaccinated against or infected with the hepatitis B virus (HBV), according to study findings from an ongoing NIAID-sponsored phase-3 study. 

HBV is spread primarily through sexual contact and sharing of contaminated needles. It causes chronic hepatitis B infection and can lead to progressive liver disease. People living with HIV, including those who are taking antiretroviral therapy, are at greater risk of liver-related illness and death when co-infected with HBV. 

The CDC reports 10% of U.S. adults with HIV also have hepatitis B. People living with HIV are less likely to produce a protective immunological response to HBV vaccination. The HEPLISAV-B vaccine was approved in 2017 by the FDA as a two-dose vaccine regimen for adults. However, little was known about its protective effects in people living with HIV.

Researchers at the University of Cincinnati College of Medicine and Weill Cornell Medical College in New York tested a three-dose course of HEPLISAV-B among 68 adults living with HIV at 38 sites in the U.S., South Africa and Thailand. None of the participants had received a previous HBV vaccination or had evidence of a previous HBV infection; all were on antiretroviral therapy. \

Following the initial dose of HEPLISAV-B vaccine by intramuscular injection, study participants received additional doses at four weeks and 24 weeks. 

All participants achieved seroprotection with 88% of participants achieving HbsAb levels greater than 1000 mIU/mL. High antibody levels are thought to be associated with long-term vaccine durability. 

The international study will continue to examine the effects of two-dose HEPLISAV-B, as well as a three-dose regimen of another hepatitis B vaccine, ENGERIX-B, among adult participants who did not achieve an adequate immunologic response. The clinical trial is estimated to complete vaccinations in March 2023.

The NIH Record

The NIH Record, founded in 1949, is the biweekly newsletter for employees of the National Institutes of Health.

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Assistant Editor: Eric Bock (link sends e-mail)

Staff Writer: Amber Snyder (link sends e-mail)