Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the persistence of specific immune responses, volunteers will be monitored for anti-Tat specific antibodies, anti-Tat proliferative response and in vitro γIFN and IL-4 production in response to Tat (Elispot). |
| Measure | Description | Time Frame |
|---|---|---|
| To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Healthy Subjects previously included in the Preventive Phase I Clinical Trial with Tat protein
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pasquale Narciso, MD | I.R.C.C.S. Spallanzani Hospital, Rome | Principal Investigator |
| Aldo Di Carlo, MD | S. Gallicano Hospital- Rome | Principal Investigator |
| Adriano Lazzarin, MD | San Raffaele Hospital - Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Milan | Italy | ||||
| I.R.C.C.S. Spallanzani Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8416373 | Background | 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. doi: 10.1128/JVI.67.1.277-287.1993. | |
| 7935812 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Whole blood, serum, PBMCs
| Rome |
| 00100 |
| Italy |
| Istituto Dermatologico S. Gallicano-IRCCS | Rome | Italy |
| 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. doi: 10.1038/371674a0. |
| 2184372 | Background | 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. doi: 10.1038/345084a0. |
| 17117011 | Background | Ensoli B, Fiorelli V, Ensoli F, Cafaro A, Titti F, Butto 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. doi: 10.1097/QAD.0b013e3280112cd1. No abstract available. |
| Related Info | View source |