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Studies of Influenza Vaccine and Tetanus-Pneumococcal Vaccine in HIV-infected Patients Receiving Interleukin-2 | Clinical Trials | Clareo Health

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Studies of Influenza Vaccine and Tetanus-Pneumococcal Vaccine in HIV-infected Patients Receiving Interleukin-2

Substudies of ESPRIT: ESPRIT Influenza Vaccine Substudy (FLUVAC) and ESPRIT Tetanus-Pneumococcal Vaccine Substudy (TEPVAC)

NCT00050726•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

Detailed Description

Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) is a 4,000 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documentation of HIV-1 infection by any licensed ELISA test and confirmed by a second method (e.g. Western Blot); or any one of the following at any time: detectable HIV p24 antigen, quantifiable plasma HIV RNA, or detectable proviral DNA.
•Absolute CD4 plus cell count of greater than or equal to 300/mm(3) within 45 days prior to randomization. (For patients who are status post-splenectomy, also a CD4 plus cell percentage greater than or equal to 20%.)
•No evidence of active clinical disease for at least one year, in the judgement of the clinician, for any AIDS-defining illness (category C., CDC, 1993) or any of the following conditions: extrapulmonary Pneumocystis carinii disease; multi-dermatomal Herpes zoster (greater than or equal to 10 lesions in a non-contiguous site); American trypanosomiasis (Chagas disease) of the CNS; Penicillium marneffii disease; visceral leishmaniasis; non-Hodgkin's lymphoma of any cell-type; Hodgkin's lymphoma; bartonellosis; microsporidiosis (greater than 1 month's duration); nocardiosis; invasive aspergillosis; or Rhodococcus equi disease.
•Age greater than or equal to 18 years.
•Laboratory values (within 45 days prior to randomization):
•AST or ALT less than or equal to 5 x the upper limit of normal (ULN).
•Total or direct bilirubin less than 2 x ULN (Patients with hyperbilirubinemia due to Gilbert's syndrome or indinavir therapy may have a serum bilirubin up to 5 x ULN.)
•Creatinine less than or equal to 2.0 mg/dl (177 micro mol/L).
•Platelet count greater than or equal to 50,000/mm(3).
•On or initiating combination antiretroviral therapy at the time of randomization. Antiretroviral therapy can include agents (approved and investigational) administered through routine care or through participation in clinical trials or expanded access programs.
+2 more criteria

Exclusion Criteria

•Prior rIL-2 therapy.
•Concurrent malignancy requiring cytotoxic chemotherapy.
•Use of systemic corticosteroids, immunosuppressants, or cytotoxic agents within 45 days prior to study randomization.
•Any CNS abnormality that requires ongoing treatment with antiseizure medication.
•Current or historical autoimmune/Inflammatory diseases including: Inflammatory bowel disease (Chron's disease, ulcerative colitis); Psoriasis; Optic neuritis; or Any autoimmune/inflammatory diseases with potentially life-threatening complications.
•Pregnancy (For women of childbearing potential, a negative pregnancy test, serum or urine, is required within 14 days prior to randomization.)
•Breast feeding.
•As for the ESPRIT protocol with the additions of patients with a history of allergic reaction to the study vaccines and/or a planned (or given) vaccination with either of the study vaccines within the 12 months following ESPRIT randomization.

Locations (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Hvidovre University Hospital@@@Copenhagen, Denmark

Copenhagen, Denmark

Key Dates

Start Date

May 1, 2001

Primary Completion Date

April 1, 2006

Completion Date

April 1, 2006

Last Updated

November 21, 2013

Enrollment

620

Estimated participants

Conditions

HIV Infections

Interventions

Interleukin-2

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Studies of Influenza Vaccine and Tetanus-Pneumococcal Vaccine in HIV-infected Patients Receiving Interleukin-2

Inclusion Criteria

Exclusion Criteria

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