Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050726
Status:
COMPLETED
Last Update Posted:
2013-11-21
First Post:
2002-12-17
Brief Title:
Studies of Influenza Vaccine and Tetanus-Pneumococcal Vaccine in HIV-infected Patients Receiving Interleukin-2
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Substudies of ESPRIT ESPRIT Influenza Vaccine Substudy FLUVAC and ESPRIT Tetanus-Pneumococcal Vaccine Substudy TEPVAC
Status:
COMPLETED
Status Verified Date:
2013-11
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 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
FLUVAC
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
TEPVAC
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
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
FLUVAC
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
TEPVAC
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
Detailed Description:
Evaluation of Subcutaneous Proleukin in a Randomized International Trial ESPRIT is a 4000 patient 6-year study investigating the clinical effect of interleukin-2 IL-2 in patients with HIV infection Because of the size and duration of this study substudies to the parent trial are being performed in order to improve the knowledge regarding the use of IL-2 in HIV-infected individuals and to enhance the overall scientific output of this international effort This protocol will serve as the umbrella under which the ESPRIT substudies will be performed at the National Institutes of Health Clinical Center
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 |
|---|---|---|---|
| 01-I-0171 | None | None | None |