Observational Study of the Preventive Trial With HIV-1 Tat Protein (ISS OBS P-001)

This study has been completed.
Information provided by:
Istituto Superiore di Sanità
ClinicalTrials.gov Identifier:
First received: December 2, 2009
Last updated: February 28, 2011
Last verified: February 2010

December 2, 2009
February 28, 2011
November 2007
Not Provided
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).
Same as current
Complete list of historical versions of study NCT01024764 on ClinicalTrials.gov Archive Site
To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.
Same as current
Not Provided
Not Provided
Observational Study of the Preventive Trial With HIV-1 Tat Protein
Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in HIV-1 Uninfected Adult Volunteers

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
Time Perspective: Prospective
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Retention:   Samples Without DNA
Whole blood, serum, PBMCs
Non-Probability Sample
Healthy Subjects previously included in the Preventive Phase I Clinical Trial with Tat protein
Healthy Subjects
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2010
Not Provided

Inclusion Criteria:

  • Previous participation to the Phase I Clinical Trial ISS P-001
18 Years to 50 Years
Contact information is only displayed when the study is recruiting subjects
Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita
Istituto Superiore di Sanità
Not Provided
Principal Investigator: 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
Istituto Superiore di Sanità
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP