Efficacy Study of T Cell Vaccination in HIV Infection

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. Identifier: NCT00407836
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : December 2, 2009
Information provided by:
Soroka University Medical Center

Brief Summary:
The hallmark of HIV infection and AIDS is the continuous attrition of CD4 T cells. One of the mechanisms that may account for the CD4 attrition , is autoimmunity against the CD4 T cells, caused by autologous immune cells. Vaccination against autoimmune reactive T cells has been successfully tried in animal models of autoimmune diseases and is now being tried in patients with Multiple Sclerosis. The purpose of the present study is to test this hypothesis in HIV infection. We will vaccinate HIV infected patients in whom specific autoimmune reactivity against CD4 is present , with their own CD4 reactive T cells. Following that, we shall study the patients and find out if the T cell vaccination caused a rise in CD4 T cell levels, and whether it influenced HIV viral load, as well as HIV and CD4 specific immunity.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: T cell vaccination Phase 2

Detailed Description:
The study will be based on forty HIV infected patients, receiving anti retroviral treatment (HAART), with CD4 levels between 150-350 and HIV plasma viral load < 5000, for at least 12 months and despite continuous anti-retroviral treatment. The patients will be randomly divided into two groups, one that will get the T cell vaccination, and the other that will serve as controls. The T cell vaccine will be prepared from autologous T cells that responded by specific proliferation to recombinant CD4, further expanded in vitro by IL-2, and then fixed by glutaraldehyde. Each vaccine portion will consist of 10,000 such cells suspended in saline and given subcutaneously every three months during the first year of the trial. The outcome measures will be CD4 levels, specific immunity to HIV antigens, immune activation profile and HIV plasma viral loads, determined sequentially during the 24 months of the trial. These outcome measures will be compared between the experimental and the control groups, to determine if this mode of treatment is effective in influencing CD4 levels as an additional mode of treatment during HIV infection.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Efficacy, Tolerability and Safety of CD4-Specific T-cell Vaccine in HIV Infection
Study Start Date : November 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Vaccination
One arm of open label T cell vaccination in which all participants will receive the T cell vaccine
Biological: T cell vaccination
Approximately 10-20 million glutaraldehyde fixed CD4 responsive autologous T cells in 1-2 ml, per vaccine injection.

Biological: T cell vaccination
Approximately 10-20 million autologous CD4 reactive T cells per each vaccine injection

Primary Outcome Measures :
  1. CD4 T cell levels [ Time Frame: one year follow up ]
  2. HIV plasma viral load [ Time Frame: one year follow up ]
  3. Clinical HIV infection [ Time Frame: one year follow up ]

Secondary Outcome Measures :
  1. HIV specific immune responses [ Time Frame: One year follow up ]
  2. CD4 specific responses [ Time Frame: One year follow up ]
  3. Immune profile [ Time Frame: One year follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. CD4 cell counts -from 150 to 450/mm3 and stable for at least 12 months, and treatment with HAART for at least 6 months.
  2. Positive cell proliferation assay to CD4 molecule
  3. Low HIV viral load (<400 - 5000 copies/ml) for at least 12 months
  4. No change of antiretroviral treatment for at least 6 months
  5. Signed informed consent

Exclusion Criteria:

  1. Concomitant immunosuppressive or antineoplastic treatment as well as chronic systemic glucocorticoid therapy.
  2. Pregnancy and women without any efficacious contraception.
  3. Clinically relevant liver disease (AST and/or ALT >2,5x upper limit of normal range, or total bilirubin > 3,5 mg/dl).
  4. Serum creatinine >1,8mg/dl or creatinine clearance <30ml/min.
  5. Patients who cannot fully understand the treatment protocol or are unable to sign the informed consent.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00407836

Soroka Medical Center
Beer Sheba, Israel
Sponsors and Collaborators
Soroka University Medical Center
Study Director: Klaris Riesenberg, M.D. Soroka U Medical Center

Publications of Results:
Responsible Party: Zvi Bentwich, M.D, Ben Gurion University of the Negev Identifier: NCT00407836     History of Changes
Other Study ID Numbers: sor444006ctil
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: November 2006

Keywords provided by Soroka University Medical Center:
CD4 T cell level
CD4 autoimmunity
Viral load
T cell vaccination
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
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
Immunologic Factors
Physiological Effects of Drugs