The BEe-HIVe Study

https://www.uwactu.com/the-bee-hive-study

A5379 is a phase III/IV, prospective, open-label, interventional, two group study being conducted at both US and non-US sites, with one group (Group A) consisting of a randomized, controlled trial with three study arms and the other group (Group B) consisting of a single arm. The study will involve adults living with HIV with a history of nonresponse to hepatitis B (HBV) vaccination (Group A HBV vaccine-experienced) and adults living with HIV with no known prior history of HBV vaccination (Group B HBV vaccine-naïve). Participants in Group A will be randomized 1:1:1 to receive HEPLISAV-B (Arm 1 [two doses] and Arm 2 [three doses]) or ENGERIX-B (Arm 3 [three doses]). Participants in Group B will receive three doses of HEPLISAV-B.

In Group A, Arms 2 and 3, the first post-entry visit (≥16 to ≤28 hours post first vaccination) is scheduled only for sample collection, and is limited to US sites only. While attendance at this first post-entry visit is strongly encouraged, Group A, Arms 2 and 3, participants may opt out of it at screening. (Arm B is closed for accrual.)

Participant Eligibility

People living with HIV

Ages 18 to 70 years old

Been on HIV treatment for more than 56 days

Previously vaccinated for Hepatitis B but it did not work

No history of Hepatitis B infection or evidence of exposure to Hepatitis B

T-Cell count greater than 100

HIV Viral load less than 1000

Not pregnant or planning pregnancy

If Diabetic, hemoglobin A1c less than 9

Contact

Clay Youngblood, RN
(206) 773-7129