hiv info source nyu medical center bellevue hospital center

A5220 - A phase II open-label pilot study, aiming to improve the immune response to Hepatitis B vaccine in HIV-positive subjects using granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant.


Eligible candidates:

  • are not infected with Hepatitis B or C
  • have never received any vaccinations for Hepatitis B
  • have CD4 T-cell counts =200 cells/mm3
  • are currently not on HAART, or have been on current HAART regimen for at least 8 weeks
  • are not pregnant or breastfeeding
  • Additional requirements will be discussed by the study nurse or doctor.

Study Objective:
The purpose of this study is to test the safety and effectiveness of the Hepatitis B vaccine, given at a higher dose and on a more frequent schedule than currently approved by the U.S. Food and Drug Administration (FDA). This study will also test the safety and effectiveness of a medicine, GM-CSF, to enhance the immune response to this vaccine.


Study Scheme:
Study participants will receive three higher doses of hepatitis B vaccine, or three higher doses of hepatitis B vaccine plus GM-CSF. The hepatitis B vaccine and GM-CSF will be given into the upper arm muscle. Study participants will know which treatment group they are in before receiving the vaccine.

Study participants will be in the study for about 60 weeks. The vaccine will be given at entry, week 4, and week 12 with or without GM-CSF. Following this, participants will come to the clinic for follow-up visits and blood work.

Study Drugs:

  • Hepatitis B vaccine
  • GM-CSF

Study Status: Closed to enrollment.

Study Staff:

Study Sponsors:

  • AIDS Clinical Trials Group (NIH)

Study Volunteers Receive:

  • Cost-free lab work
  • Transportation reimbursement