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 Sanita

ClinicalTrials.gov Identifier:

NCT01024764

First received: December 2, 2009

Last updated: February 28, 2011

Last verified: February 2010

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Istituto Superiore di Sanita:

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

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 Sanita

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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. Review. No abstract available.

Responsible Party:	Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita
ClinicalTrials.gov Identifier:	NCT01024764 History of Changes
Other Study ID Numbers:	ISS OBS P-001
Study First Received:	December 2, 2009
Last Updated:	February 28, 2011
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Istituto Superiore di Sanita:

HIV
Tat protein
Preventive vaccine

ClinicalTrials.gov processed this record on May 22, 2013

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