Healthy Subjects Clinical Trial
— ISS OBS P-001Official title:
Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in HIV-1 Uninfected Adult Volunteers
Verified date | February 2010 |
Source | Istituto Superiore di Sanità |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: The Italian Medicines Agency |
Study type | Observational |
The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS
P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe,
well tolerated and immunogenic. The present study is intended to extend the follow-up of the
volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and
cellular immune response. The results of the present study will be key for the design of
future phase II trials, particularly for the definition of the optimal schedule for boosting
immunizations.
All individuals (20) will be enrolled in a 120-weeks observational study and monitored every
24 weeks for the following 3 years. During these visits, in addition to the hematological
and biochemical assessment, the anti-Tat specific humoral and cellular immune responses will
be evaluated.
Status | Completed |
Enrollment | 5 |
Est. completion date | December 2010 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Previous participation to the Phase I Clinical Trial ISS P-001 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | San Raffaele Hospital | Milan | |
Italy | I.R.C.C.S. Spallanzani Hospital | Rome | |
Italy | Istituto Dermatologico S. Gallicano-IRCCS | Rome |
Lead Sponsor | Collaborator |
---|---|
Istituto Superiore di Sanità |
Italy,
Ensoli B, Barillari G, Salahuddin SZ, Gallo RC, Wong-Staal F. Tat protein of HIV-1 stimulates growth of cells derived from Kaposi's sarcoma lesions of AIDS patients. Nature. 1990 May 3;345(6270):84-6. — View Citation
Ensoli B, Buonaguro L, Barillari G, Fiorelli V, Gendelman R, Morgan RA, Wingfield P, Gallo RC. Release, uptake, and effects of extracellular human immunodeficiency virus type 1 Tat protein on cell growth and viral transactivation. J Virol. 1993 Jan;67(1):277-87. — View Citation
Ensoli B, Fiorelli V, Ensoli F, Cafaro A, Titti F, Buttò S, Monini P, Magnani M, Caputo A, Garaci E. Candidate HIV-1 Tat vaccine development: from basic science to clinical trials. AIDS. 2006 Nov 28;20(18):2245-61. Review. — View Citation
Ensoli B, Gendelman R, Markham P, Fiorelli V, Colombini S, Raffeld M, Cafaro A, Chang HK, Brady JN, Gallo RC. Synergy between basic fibroblast growth factor and HIV-1 Tat protein in induction of Kaposi's sarcoma. Nature. 1994 Oct 20;371(6499):674-80. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the persistence of specific immune responses, volunteers will be monitored for anti-Tat specific antibodies, anti-Tat proliferative response and in vitro ?IFN and IL-4 production in response to Tat (Elispot). | |||
Secondary | To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials. |
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