Updated Hep B Vaccine May Improve Antibody Response in People with HIV: Study Suggests - Video

A newer vaccine against hepatitis B virus was clearly superior to an older vaccine type in inducing a protective antibody response among people living with HIV who didn’t respond to prior vaccination, according to the results of an international study led by a Weill Cornell Medicine investigator.

The study, reported in JAMA, showed that hepatitis B vaccine with a cytosine phosphoguanine adjuvant, known as HepB-CpG, induced protective levels of antibodies in up to 99.4% of the subjects who received it. Such protection was seen in only 80.6% of subjects who received hepatitis B vaccine with an aluminum hydroxide adjuvant, known as HepB-alum.

The NIH-sponsored BEe-HIVe (B-Enhancement of HBV Vaccination in Persons Living With HIV) trial is a phase 3 study with 561 participants at 40 sites across North and South America, Africa and Asia. The participants are people with HIV who reported prior vaccination against hepatitis B but lacked protective levels of antibodies.

Each participant received either HepB-CpG or HepB-alum. Both types of vaccine use the same quantity of the same lab-made hepatitis B virus protein to induce anti-hepatitis-B responses; they differ primarily in their “adjuvants,” which are compounds added to provide general stimulation to the immune system’s ability to mount an antibody response.

The United States Food and Drug Administration (FDA) approved HepB-CpG for use in adults in 2017. The results suggest that clinicians will now prefer it over alum-adjuvant vaccines for boosting immunity against hepatitis B in adults with HIV who have little or no existing antibody protection.

In an earlier part of the current study, Dr. Marks and colleagues also found that Heplisav-B induced protective antibody responses in 100% of people with HIV who had otherwise never been vaccinated against hepatitis B.

The new analysis included three arms: the HepB-CpG vaccine in three doses, the HepB-alum vaccine in three doses, and the HepB-CpG vaccine in its standard regimen of two doses. Both of the Hep-CpG arms were superior to HepB-alum, with 99.4% (three-doses) and 93.1% (two doses) of people in those groups showing protective levels of vaccine-induced antibodies, compared with 80.6% of those in the HepB-alum group. The trial did not uncover new safety issues.

Reference: Marks KM, Kang M, Umbleja T, et al. HepB-CpG vs HepB-Alum Vaccine in People With HIV and Prior Vaccine Nonresponse: The BEe-HIVe Randomized Clinical Trial. JAMA. Published online December 01, 2024. doi:10.1001/jama.2024.24490