People with HIV can be protected against hepatitis B with a three-dose vaccine regimen

A study that was presented at the IDWeek conference recently is groundbreaking for HIV research.

A news release published by the U.S. National Institute of Health (NIH) states that "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 presented at the IDWeek conference held in Washington D.C.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsors the ongoing Phase 3 ACTG A5379 clinical study.

Ten percent of adult Americans have it

HIV, which we can describe as the great epidemic of the 1980s, can be transmitted through blood and sexual intercourse. Many people lost their lives due to the lack of treatment for HIV at that time. However, this treatment could be a silver lining for reducing the spread of the virus.

As stated in the release, HBV causes chronic hepatitis B infection and can lead to progressive liver disease. Co-infection of HIV with HBV increases the risk of liver-related disease and death in HIV-positive individuals, including those on antiretroviral therapy.

Ten percent of adults in the U.S. who are infected with HIV also have hepatitis B, according to the Centers for Disease Control and Prevention. HIV-positive individuals have a lower likelihood of developing a protective immune response to HBV vaccination.

The U.S. Food and Drug Administration authorized the HEPLISAV-B vaccine, produced by Dynavax Technologies Corp. in Emeryville, California, as a two-dose vaccination schedule for adults in 2017. On the other hand, little was understood about its anti-HIV actions.

Individuals achieved seroprotection

The research team, led by study chairs Kristen Marks, M.D., of Weill Cornell Medical College in New York City and Kenneth E. Sherman, M.D., Ph.D., of the University of Cincinnati College of Medicine, tested a three-dose course of HEPLISAV-B on 68 HIV-positive adults at 38 sites in the U.S., South Africa, and Thailand.

All of the subjects were on antiretroviral medication; none had ever been immunized against HBV or had any indication that they had ever been infected with it.

Participants in the research received a 0.5 milliliter (mL) intramuscular dose of the HEPLISAV-B vaccine, followed by doses at four and 24 weeks. This portion of the trial aimed to evaluate anti-HBV surface antibodies (HBsAbs) greater than or equal to 10 mIU/mL at week 28 (defined as seroprotection from HBV) and to evaluate the safety of the vaccine.

The results showed that nearly all individuals achieved seroprotection, with 88 percent of the subjects obtaining HbsAb levels greater than 1000 mIU/mL. Long-term vaccination durability is assumed to be correlated with high antibody levels.

At eight weeks following the second dose, 94.4 percent of subjects had attained seroprotection; by week 24 before the third dose, this percentage had climbed to 98.5 percent. The most frequent adverse reactions following vaccination were soreness at the injection site, malaise, exhaustion, muscular aches, and headaches.

The two-dose HEPLISAV-B regimen and a three-dose regimen of a different hepatitis B vaccine (ENGERIX-B, produced by GSK) will both be tested in the ongoing international study on adult participants with HIV who have previously received an HBV vaccination but did not experience an adequate immunologic response. Vaccinations for the clinical trial are anticipated to end in March 2023.