Studies of Influenza Vaccine and Tetanus-Pneumococcal Vaccine in HIV-infected Patients Receiving Interleukin-2
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00050726|
Recruitment Status : Completed
First Posted : December 18, 2002
Last Update Posted : November 21, 2013
This investigation is a sub-study of the 6-year multinational ESPRIT (Evaluation of Subcutaneous Proleukin in a Randomized International Trial) protocol. It will compare the effectiveness of the influenza (FLUVAC) and tetanus-pneumococcal (TEPVAC) vaccines in HIV-infected patients receiving interleukin-2 (IL-2) plus anti-HIV drugs with those receiving only anti-HIV drugs. IL-2 is a protein naturally produced by immune cells called lymphocytes. Lymphocytes from patients with HIV do not produce IL-2 normally. The ESPRIT trial is evaluating whether HIV-infected patients treated with antiretroviral drugs plus IL-2 have fewer serious infections and improved survival than those receiving only anti-HIV drugs.
Participants in this sub-study will be drawn from patients enrolled in ESPRIT. They must be 18 years of age or older, have HIV infection with no symptoms of significant HIV illness. They will be vaccinated against either influenza or tetanus and pneumococcus, as follows:
Potentially eligible patients will be screened for the FLUVAC study during an ESPRIT follow-up visit. Those who are eligible and agree to participate will have 10 ml (1 tablespoon) of blood drawn to assess baseline antibody levels and then receive the vaccination. They will be vaccinated annually for 3 years. A blood sample (10 ml) will be drawn 1 month after each vaccination to measure the immune response. Some of the blood drawn for this study will be stored and used for research purposes.
Participants will have 10 ml of blood drawn to assess their baseline antibody levels. They will receive two vaccinations (tetanus and pneumococcus) 12 months after enrolling in ESPRIT and another two vaccinations 24 months after enrollment. A blood sample (10 ml) will be drawn 1 month after each vaccination to measure the immune response. Some of the blood drawn for this study will be stored and used for research purposes.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Interleukin-2||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||620 participants|
|Official Title:||Substudies of ESPRIT: ESPRIT Influenza Vaccine Substudy (FLUVAC) and ESPRIT Tetanus-Pneumococcal Vaccine Substudy (TEPVAC)|
|Study Start Date :||May 2001|
|Actual Primary Completion Date :||April 2006|
|Actual Study Completion Date :||April 2006|
- The proportion of patients with eroconversion to one or more vaccine antigens. [ Time Frame: Month1 post-vaccination. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050726
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Hvidovre University Hospital@@@Copenhagen, Denmark|
|Copenhagen, Denmark, 00/00/00|