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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00050726
First received: December 17, 2002
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Interleukin-2
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Substudies of ESPRIT: ESPRIT Influenza Vaccine Substudy (FLUVAC) and ESPRIT Tetanus-Pneumococcal Vaccine Substudy (TEPVAC)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • The proportion of patients with eroconversion to one or more vaccine antigens. [ Time Frame: Month1 post-vaccination. ]

Estimated Enrollment: 620
Study Start Date: May 2001
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Interleukin-2
    N/A
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA - ESPRIT PROTOCOL:

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.

Signed informed consent form.

INCLUSION CRITERIA - FLUVAC STUDY:

Patients eligible for the ESPRIT trial are eligible for the FLUVAC study, except for patients with known allergy to egg, a history of allergic reaction(s) to influenza vaccination or who had an influenza vaccine less than or equal to 6 months after ESPRIT randomization and during the influenza vaccine season, i.e. between September 1st and January 31st on the Northern hemisphere and between February 1st and June 30th on the Southern hemisphere.

The inclusion criteria will be the same as the ESPRIT protocol.

EXCLUSION CRITERIA - ESPRIT PROTOCOL:

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.

EXCLUSION CRITERIA - FLUVAC:

As for the ESPRIT protocol with the addition patients allergic to egg, with a history of allergic reaction(s) to influenza vaccination or who had a influenza vaccine less than or equal to 6 months before inclusion are not eligible for this study.

EXCLUSION CRITERIA - TEPVAC:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050726

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Denmark
Hvidovre University Hospital@@@Copenhagen, Denmark
Copenhagen, Denmark, 00/00/00
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

Responsible Party: DAIDS, NIAID
ClinicalTrials.gov Identifier: NCT00050726     History of Changes
Other Study ID Numbers: 010171, 01-I-0171
Study First Received: December 17, 2002
Last Updated: November 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Interleukin-2
Immunotherapy
HIV
IL-2

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Influenza, Human
Tetanus
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014