Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272493
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2006-01-04
Brief Title:
Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG A5220 | Registry Identifier | DAIDS ES Registry ID | None |
| 10148 | REGISTRY | None | None |