Who is sponsoring ISS OBS P-001?

ISS OBS P-001 is sponsored by Istituto Superiore di Sanità.

What condition does ISS OBS P-001 study?

ISS OBS P-001 studies Healthy Subjects.

What is the status of ISS OBS P-001?

ISS OBS P-001 is currently COMPLETED.

Last reviewed 2011-02-28 · How we verify

Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in HIV-1 Uninfected Adult Volunteers (ISS OBS P-001)

NCT01024764 COMPLETED

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.

Details

Lead sponsor	Istituto Superiore di Sanità
Status	COMPLETED
Enrolment	5
Start date	2007-11
Completion	2010-12

Conditions

Healthy Subjects

Primary outcomes

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).

Countries

Italy