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Observational Study of the Preventive Trial With HIV-1 Tat Protein

2014-07-24 14:10:43 | BioPortfolio

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.

Study Design

Time Perspective: Prospective

Conditions

Healthy Subjects

Location

San Raffaele Hospital
Milan
Italy
00100

Status

Completed

Source

Istituto Superiore di Sanita

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:43-0400

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