Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069914
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-10-02
Brief Title:
Immune Response to Influenza Vaccine in HIV-Infected Individuals
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Immune Response to Influenza Vaccination in HIV-Infected Individuals
Status:
COMPLETED
Status Verified Date:
2005-09
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:
This study will evaluate how HIV infection including CD4 cell count and viral load affects the patients ability to produce antibodies in response to vaccination with the influenza flu vaccine Earlier studies have shown that people with HIV infection do not respond as well as healthy subjects to flu vaccine that is they dont make as many antibodies in response to the vaccine Before the use of current anti-HIV medications antibodies made to flu vaccination in HIV-positive individuals was related to their CD4 cell count This trial will examine how CD4 counts and the amount of virus in the blood affect how much and what kind of antibodies the body makes to the flu vaccine
HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be eligible for this study Healthy subjects will serve as controls to make sure the flu vaccine works ie stimulates production of enough antibody to protect against the flu and to compare the amount of antibodies made by HIV-positive and HIV-negative people Candidates will be screened with a medical history and blood tests see below Women who are able to have children will have a pregnancy test Pregnant women are excluded from the study
Participants will undergo the following procedures
1 Blood drawing for the following tests
Routine tests complete blood count kidney and liver functions electrolyte levels
CD4 cell count
HLA typing a genetic marker of the immune system if it has not already been done at the NIH This test may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions Determining HLA type is necessary to be able to perform certain research studies Some HLA types have been associated with an increased risk of certain diseases like arthritis and other rheumatologic problems
Viral load HIV-infected patients only
Influenza antibody levels
B cell levels
2 Flu vaccination
3 Follow-up visits on days 7 28 and 54 after vaccination for the following
Review of any illnesses or fever
Review of medications if any changes were made
Repeat blood tests
HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be eligible for this study Healthy subjects will serve as controls to make sure the flu vaccine works ie stimulates production of enough antibody to protect against the flu and to compare the amount of antibodies made by HIV-positive and HIV-negative people Candidates will be screened with a medical history and blood tests see below Women who are able to have children will have a pregnancy test Pregnant women are excluded from the study
Participants will undergo the following procedures
1 Blood drawing for the following tests
Routine tests complete blood count kidney and liver functions electrolyte levels
CD4 cell count
HLA typing a genetic marker of the immune system if it has not already been done at the NIH This test may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions Determining HLA type is necessary to be able to perform certain research studies Some HLA types have been associated with an increased risk of certain diseases like arthritis and other rheumatologic problems
Viral load HIV-infected patients only
Influenza antibody levels
B cell levels
2 Flu vaccination
3 Follow-up visits on days 7 28 and 54 after vaccination for the following
Review of any illnesses or fever
Review of medications if any changes were made
Repeat blood tests
Detailed Description:
The purpose of this protocol is to evaluate the effect of HIV viral load and CD4 counts on the generation of influenza-specific antibodies and influenza-specific B cell responses in HIV-infected adults HIV-infected subjects will be enrolled to receive the influenza vaccine appropriate to the on-going USA influenza season Oct-March Laboratory studies including influenza titers influenza-specific B cell frequencies CD4 counts and HIV viral loads will be obtained at baseline day of vaccination day 7 28 and 54 post-vaccination HIV-negative healthy volunteers will serve as controls Although there are some risks to influenza vaccine the CDC Advisory Committee on Immunizations recommends influenza vaccination for HIV-infected patients The primary study risks are those of phlebotomy and the inconvenience of multiple visits Subjects will be compensated for participation in the study Total enrollment of the study is a maximum of 165 subjects 132 HIV-infected individuals and 33 HIV-negative controls
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 |
|---|---|---|---|
| 03-I-0310 | None | None | None |