Observational Study of the Preventive Trial With HIV-1 Tat Protein
- Conditions
- Healthy Subjects
- Registration Number
- NCT01024764
- Lead Sponsor
- Istituto Superiore di Sanità
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- Previous participation to the Phase I Clinical Trial ISS P-001
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.
Trial Locations
- Locations (3)
San Raffaele Hospital
🇮🇹Milan, Italy
I.R.C.C.S. Spallanzani Hospital
🇮🇹Rome, Italy
Istituto Dermatologico S. Gallicano-IRCCS
🇮🇹Rome, Italy