The BEe-HIVe STUDY
We are looking for everyone living with HIV who have been previously vaccinated for Hepatitis B but it did not work OR who have never been vaccinated for Hepatitis B, have no history of Hepatitis B infection nor evidence of exposure to Hepatitis B.
About this Study
Vaccination for Hepatitis B in people living with HIV does not always work, especially in those with impaired immune systems or ability to fight infection.
A new vaccine, called HEPLISAV-B, has been approved that may provide a better response than other Hepatitis B vaccines.
We will study whether this vaccine is more effective than the current standard vaccine EGENERIX-B.
Participants will be randomized (like flipping a coin) to receive either HEPLISAV-B vaccine or EGENERIX-B vaccine.
Requirements to Enter Study:
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 or have never been vaccinated for Hepatitis B
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
Length of Study:
Approximately 72 weeks
Schedule of Study Appointments:
Arm A (Previously vaccinated for Hepatitis B): Screening, Entry, visits at weeks 4, 8, 12, 24, 28, 52 and 72
Arm B (Never vaccinated for Hepatitis B): Screening, Entry, visits at weeks 4, 8, 12, 24, 28, 32, 48 and 72
Medications administered during study:
HEPLSAV-B vaccine (injection) or EGENERIX-B vaccine (injection)
Medical histories, Physical exams, Blood draws, IM Vaccination (injection)
$20 per visit starting at Entry
ACTU Screening at 206-733-7129 (call or text)