Efficacy Study of T Cell Vaccination in HIV Infection
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: T cell vaccination |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Efficacy, Tolerability and Safety of CD4-Specific T-cell Vaccine in HIV Infection |
- CD4 T cell levels [ Time Frame: one year follow up ] [ Designated as safety issue: No ]
- HIV plasma viral load [ Time Frame: one year follow up ] [ Designated as safety issue: No ]
- Clinical HIV infection [ Time Frame: one year follow up ] [ Designated as safety issue: No ]
- HIV specific immune responses [ Time Frame: One year follow up ] [ Designated as safety issue: No ]
- CD4 specific responses [ Time Frame: One year follow up ] [ Designated as safety issue: No ]
- Immune profile [ Time Frame: One year follow up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2006 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- CD4 cell counts -from 150 to 450/mm3 and stable for at least 12 months, and treatment with HAART for at least 6 months.
- Positive cell proliferation assay to CD4 molecule
- Low HIV viral load (<400 - 5000 copies/ml) for at least 12 months
- No change of antiretroviral treatment for at least 6 months
- Signed informed consent
Exclusion Criteria:
- Concomitant immunosuppressive or antineoplastic treatment as well as chronic systemic glucocorticoid therapy.
- Pregnancy and women without any efficacious contraception.
- Clinically relevant liver disease (AST and/or ALT >2,5x upper limit of normal range, or total bilirubin > 3,5 mg/dl).
- Serum creatinine >1,8mg/dl or creatinine clearance <30ml/min.
- Patients who cannot fully understand the treatment protocol or are unable to sign the informed consent.
Contacts and Locations More Information
Publications:
| Responsible Party: | Zvi Bentwich, M.D, Ben Gurion University of the Negev |
| ClinicalTrials.gov Identifier: | NCT00407836 History of Changes |
| Other Study ID Numbers: | sor444006ctil |
| Study First Received: | December 3, 2006 |
| Last Updated: | December 1, 2009 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Soroka University Medical Center:
|
HIV CD4 T cell level CD4 autoimmunity |
Viral load T cell vaccination HIV Therapeutic Vaccine |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 22, 2013