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

This study has been completed.
Sponsor:
Information provided by:
Istituto Superiore di Sanità
ClinicalTrials.gov Identifier:
NCT01024764
First received: December 2, 2009
Last updated: February 28, 2011
Last verified: February 2010
  Purpose

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.


Condition
Healthy Subjects

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in HIV-1 Uninfected Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Istituto Superiore di Sanità:

Primary Outcome Measures:
  • 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:
  • To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.

Biospecimen Retention:   Samples Without DNA

Whole blood, serum, PBMCs


Enrollment: 5
Study Start Date: November 2007
Study Completion Date: December 2010
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Subjects previously included in the Preventive Phase I Clinical Trial with Tat protein

Criteria

Inclusion Criteria:

  • Previous participation to the Phase I Clinical Trial ISS P-001
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024764

Locations
Italy
San Raffaele Hospital
Milan, Italy
I.R.C.C.S. Spallanzani Hospital
Rome, Italy, 00100
Istituto Dermatologico S. Gallicano-IRCCS
Rome, Italy
Sponsors and Collaborators
Istituto Superiore di Sanità
Investigators
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
  More Information