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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00272493 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Biological: Hepatitis B virus vaccine with GM-CSF adjuvant Biological: Hepatitis B virus vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Improving Immune Response to Hepatitis B Vaccine in HIV-Positive Subjects Using Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) as a Vaccine Adjuvant: A Phase II Open-Label Pilot Study |
Enrollment: | 48 |
Study Start Date: | December 2006 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12.
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Biological: Hepatitis B virus vaccine
Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12.
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B: Experimental
Arm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12.
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Biological: Hepatitis B virus vaccine with GM-CSF adjuvant
Arm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12.
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Highly active antiretroviral therapy (HAART) has greatly improved the life of HIV infected individuals. Before the introduction of HAART, the impact of HBV infection and liver disease was less prominent due to the rapid progression to AIDS. However, with the use of HAART, liver disease has become a leading cause of death in HIV infected individuals; therefore, prevention of HBV infection is essential. Most HIV infected people respond poorly to HBV vaccines. GM-CSF is a cytokine produced primarily by activated T and B cells and has been used extensively as a hematopoietic growth factor. GM-CSF increases neutrophil count, improves antigen-presenting cell function, and is involved in the development and improvement of cellular immune responses. Past research has shown that GM-CSF improves the immune response to HBV vaccination in people with kidney disease. The purpose of this study is to evaluate the safety and effectiveness of GM-CSF as an adjuvant to improve the immune response to HBV vaccination in HIV infected individuals.
This study will last 60 weeks. Participants will be randomly assigned to 1 of 2 arms. Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12. Arm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12. Participants will be stratified by their screening HIV-1 viral load. After completing the vaccination series, study visits will occur at Weeks 16, 36, and 60. Blood collection, a physical exam, and liver function and hepatitis antibody tests will be completed at all study visits. Telephone follow-up by study staff will occur 48 to 96 hours post-vaccination.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611-3015 | |
Rush. Univ. Med. Ctr, Dept of Infectious Disease | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
University of Maryland Biotech. Institute, Inst. of Human Virology | |
Baltimore, Maryland, United States, 21201 | |
United States, Missouri | |
Washington University (St. Louis) | |
St. Louis, Missouri, United States, 63108-2138 | |
United States, New York | |
NYU/Bellevue | |
New York, New York, United States, 10016-6481 | |
Univ. of Rochester Med. Ctr. | |
Rochester, New York, United States, 14642-0001 | |
AIDS Community Health Ctr. | |
Rochester, New York, United States, 14642-0001 | |
United States, North Carolina | |
Duke University Medical Center Division of Infectious Diseases | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Case Western Reserve Univ. | |
Cleveland, Ohio, United States, 44106-5083 | |
MetroHealth Med. Ctr. | |
Cleveland, Ohio, United States, 44109-1998 | |
Univ. of Cincinnati | |
Cincinnati, Ohio, United States, 45267-0405 | |
Ohio State Univ. College of Medicine | |
Columbus, Ohio, United States, 43210 | |
United States, Texas | |
Univ. of Texas Medical Branch, ACTU | |
Galveston, Texas, United States, 77555-0435 | |
United States, Washington | |
University of Washington, Harbor Medical Center | |
Seattle, Washington, United States, 98104 |
Study Chair: | Judith A. Aberg, MD | New York University School of Medicine |
Study Chair: | Edgar (Turner) Overton, MD | AIDS Clinical Trials Unit, Washington University at St. Louis |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5220 |
Study First Received: | January 4, 2006 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00272493 |
Health Authority: | United States: Food and Drug Administration |
Treatment Experienced Treatment Naive |
Sexually Transmitted Diseases, Viral Liver Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis Virus Diseases |
Digestive System Diseases HIV Seropositivity HIV Infections Sexually Transmitted Diseases Hepatitis B DNA Virus Infections Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Lentivirus Infections Infection Hepadnaviridae Infections |