A5379: BEEHIVE, a Hepatitis-B Vaccine Study for People Living with HIV

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Title: A5379 BEEHIVE

B-Enhancement of HBV Vaccination in Persons Living with HIV (BEe-HIVe)

Description

Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. Although there is a vaccination for hepatitis B, sometimes the vaccines do not work well for people living with HIV. A new vaccine, HEPLISAV-B, has been approved and may provide a better response for people living with HIV than the standard vaccine, ENGERIX-B. The purpose of this study is to see if HEPLISAV-B provides better protection against hepatitis B than ENGERIX-B in people living with HIV.

The BEEHIVE study will enroll two different groups of people. Group A is for people living with HIV who were vaccinated against hepatitis B before, but the vaccine did not cause the needed immune response for protection. Group B is made up of people living with HIV who have never been vaccinated for hepatitis B.

How It Works

Participants in Group A will be randomly (like the flip of a coin) selected to be in one of three “arms.” Participants do not have a choice into which arm they will participate. Participants will be told to which arm they have been assigned.

  • Arm 1: Participants will receive two doses of HEPLISAV-B vaccine: one in week 0 and one in week 4.
  • Arm 2: Participants will receive three doses of HEPLISAV-B vaccine: one in week 0, one in week 4 and one in week 24.
  • Arm 3: Participants will receive three doses of ENGERIX-B vaccine: one in week 0, one in week 4 and one in week 24.

Participants in Group B will receive three doses of HEPLISAV-B: one in week 0, one in week 4 and one in week 24.

All participants will be in the study for about 72 weeks. Compensation is provided.

Requirements to Enter Study

  • Adults 18+ who are living with HIV.
  • On HIV meds for 56+ days.
  • CD4 T-cell count >100.
  • HIV viral load <1,000.
  • For people in Group A:
    o Blood tests showing that prior hepatitis B vaccine didn’t work or didn’t work well.
    o Prior hepatitis B vaccination given more than 168 days prior to study entry.
  • For people in Group B: Blood test showing no prior hepatitis B vaccine.
  • No previous hepatitis B infection or exposure to hepatitis B.
  • Other requirements we can review with you.

More detail on the NIH study page: clinicaltrials.gov/ct2/show/NCT04193189