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Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals
This study has been completed.
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00272493
First received: January 4, 2006
Last updated: May 17, 2012
Last verified: May 2012
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Purpose
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 |
|---|---|---|
| HIV Infections | Biological: Hepatitis B virus vaccine with GM-CSF adjuvant Biological: Hepatitis B virus vaccine | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Quantitative hepatitis B surface antibody (HBsAb) [ Time Frame: At Week 16 ]
- Occurrence of Grade 3 or higher adverse events (including hypersensitivity reaction) related to study regimens and HIV viral load increase greater than 1 log(10) [ Time Frame: Throughout the study ]
Secondary Outcome Measures:
- Quantitative HBsAb 24 and 48 weeks after completion of HBV vaccination series [ Time Frame: At Weeks 36 and 60 ]
- HBsAb response, defined as titer greater than 10 mlU/ml at 4, 24, and 48 weeks after completion of HBV vaccination series [ Time Frame: At Weeks 16, 36, and 60 ]
- Changes in HIV viral load from baseline [ Time Frame: At Weeks 4, 16, and 60 ]
- Changes in white blood cell and absolute neutrophil count from baseline [ Time Frame: At Weeks 4, 16, and 36 ]
- Occurrence of Grade 2 or higher adverse events [ Time Frame: Throughout the study ]
- Changes in CD4 count from baseline [ Time Frame: At Weeks 4, 16, and 60 ]
| Enrollment: | 48 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12.
|
Biological: Hepatitis B virus vaccine
Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12.
|
|
Experimental: B
Arm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12.
|
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272493
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272493
Locations
| United States, Illinois | |
| Northwestern University CRS | |
| Chicago, Illinois, United States, 60611-3015 | |
| Rush Univ. Med. Ctr. ACTG CRS | |
| Chicago, Illinois, United States, 60611 | |
| United States, Missouri | |
| Washington U CRS | |
| St. Louis, Missouri, United States, 63108-2138 | |
| United States, New York | |
| NY Univ. HIV/AIDS CRS | |
| New York, New York, United States, 10016-6481 | |
| Univ. of Rochester ACTG CRS | |
| Rochester, New York, United States, 14642-0001 | |
| United States, North Carolina | |
| Univ. of Rochester ACTG CRS | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Univ. of Cincinnati CRS | |
| Cincinnati, Ohio, United States, 45267-0405 | |
| Case CRS | |
| Cleveland, Ohio, United States, 44106-5083 | |
| MetroHealth CRS | |
| Cleveland, Ohio, United States, 44109-1998 | |
| The Ohio State Univ. AIDS CRS | |
| Columbus, Ohio, United States, 43210 | |
| United States, Washington | |
| University of Washington AIDS CRS | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
| Study Chair: | Judith A. Aberg, MD | New York University |
| Study Chair: | Edgar (Turner) Overton, MD | AIDS Clinical Trials Unit, Washington University at St. Louis |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00272493 History of Changes |
| Other Study ID Numbers: |
A5220 10148 ( Registry Identifier: DAIDS ES Registry ID ) ACTG A5220 |
| Study First Received: | January 4, 2006 |
| Last Updated: | May 17, 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Treatment Experienced Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Hepatitis B Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Hepadnaviridae Infections DNA Virus Infections Hepatitis, Viral, Human Hepatitis Liver Diseases Digestive System Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 22, 2017