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)

 

Study Procedures:  

Medical histories, Physical exams, Blood draws, IM Vaccination (injection)

 

Reimbursement: 

$20 per visit starting at Entry

 

Contact: 

ACTU Screening  at 206-733-7129 (call or text)

Harborview Medical Center

325 9th Avenue

2nd Floor West Clinic

Seattle, WA 98104

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