Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals

Completed · Phase 2

Conditions studied: HIV Infections

In brief

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a naturally occurring substance that is made by the body in response to infection or inflammation, and greatly improves cellular immune responses. The purpose of this study is to evaluate the safety and effectiveness of GM-CSF as an adjuvant to improve the immune response to hepatitis B virus (HBV) vaccination in HIV infected individuals.

Key facts

Study ID

NCT00272493

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

48

Expected to finish

2008-09-01

Last updated by the study team

2021-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV infected
• CD4 count of 200 cells/mm3 or more within 30 days prior to study entry
• HIV-1 RNA viral load value obtained within 30 days prior to study entry
• Received HAART for at least 8 weeks prior to study entry OR not on HAART within 8 weeks prior to study entry with no plans to start HAART during the study. Participants receiving HAART must be on stable therapy as defined by the protocol.
• Negative hepatitis B core total antibody (HBcAb total), qualitative hepatitis B surface antibody (HBsAb), and hepatitis B surface antigen (HBsAg) tests within 30 days prior to study entry
• Negative hepatitis C virus (HCV) antibody test, completed within 30 days prior to study entry
• Willing to use acceptable forms of contraception

You may not qualify if…

• HCV antibody or HCV RNA positive at any time prior to study entry
• Previously vaccinated against HBV
• Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, vaccines, interleukins, interferons, growth factors, or intravenous immune globulin within 30 days prior to study entry
• Known allergy or sensitivity to any component of the study drugs
• Active drug or alcohol dependence that would interfere with participation in the study
• Any mental illness that may interfere with the study
• Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
• Body weight less than 50 kg (110 lbs)
• Abnormal lab values
• Pregnant or breastfeeding

Where it is running

• Northwestern University CRS — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Washington U CRS — St Louis, Missouri, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Univ. of Rochester ACTG CRS — Durham, North Carolina, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Case CRS — Cleveland, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States
• University of Washington AIDS CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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