Influenza Vaccine in HIV Infection: Immune Response and Effect on Viral Load
|ClinicalTrials.gov Identifier: NCT00025922|
Recruitment Status : Completed
First Posted : November 1, 2001
Last Update Posted : March 4, 2008
This 2-part study will examine 1) the immune response to influenza (flu) vaccine in HIV-infected patients, and 2) the effect of flu vaccine on HIV viral loads. Earlier studies have shown that people with HIV infection do not respond as well to flu vaccine as healthy subjects; that is, they don't make as many antibodies in response to the vaccine. Also, studies done before the use of HAART (highly active antiretroviral treatment) have shown that HIV levels increase for a period of time after flu vaccination. One small study showed a small brief increase in HIV even in patients taking HAART. The current trial will examine whether the flu vaccine does, in fact, cause an elevation in viral load and whether this increase is harmful or indicates a better response to the vaccine.
HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be eligible for part1of this study. (Healthy volunteers will serve as control subjects to make sure the flu vaccine stimulates production of enough antibody to protect against the flu). Part 2 will include only HIV-infected patients with fewer than 50 copies per milliliter of HIV. Patients in both parts of the study must have been receiving HAART (consisting of at least two nucleoside reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor) for at least 3 months before enrollment in the study. Candidates will be screened with a medical history and blood tests, including HLA testing (a genetic test of immune system markers). 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:
- Part 1 - Immune Response to Flu Vaccine
In the first of two visits, participants will have blood drawn for flu antibody levels before vaccination and, in HIV-infected patients, measures of T cell count and viral load. They will then receive the flu vaccine. Blood will be drawn at a second visit 28 days later for the same tests.
- Part 2 - Effect of Flu Vaccine on Viral Levels
Participants will be randomly assigned to receive the flu vaccine either at the beginning of their enrollment in the study (immediate) or 3 weeks after enrollment (deferred). Those in the immediate group receive the flu vaccine on the first day (day 0) and have blood drawn on days 0, 3, 7, 10, 14, 17, 21, 24, 28, 31, 35, 38 and 42. Those in the deferred group are vaccinated on day 21 and have blood drawn on days 0, 3, 7, 10, 14, 17, 21, 24, 28, 31, 35, 38, 42 and 49. The blood is tested for viral load, CD4 cell counts and antibody levels.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Influenza Vaccine in HIV Infection: Immunologic Responses and Effect on HIV Viral Load|
|Study Start Date :||October 2001|
|Estimated Study Completion Date :||October 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025922
|United States, Maryland|
|National Institute of Allergy and Infectious Diseases (NIAID)|
|Bethesda, Maryland, United States, 20892|