Observational Study of the Preventive Trial With HIV-1 Tat Protein (ISS OBS P-001)
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| ClinicalTrials.gov Identifier: NCT01024764 |
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Recruitment Status
:
Completed
First Posted
: December 3, 2009
Last Update Posted
: March 1, 2011
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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 or disease |
|---|
| Healthy Subjects |
| Study Type : | Observational |
| Actual Enrollment : | 5 participants |
| 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 |
| Study Start Date : | November 2007 |
| Actual Study Completion Date : | December 2010 |
- 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).
- To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Previous participation to the Phase I Clinical Trial ISS P-001
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024764
| Italy | |
| San Raffaele Hospital | |
| Milan, Italy | |
| I.R.C.C.S. Spallanzani Hospital | |
| Rome, Italy, 00100 | |
| Istituto Dermatologico S. Gallicano-IRCCS | |
| Rome, Italy | |
| 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 |
Additional Information:
Publications:
| Responsible Party: | Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita |
| ClinicalTrials.gov Identifier: | NCT01024764 History of Changes |
| Other Study ID Numbers: |
ISS OBS P-001 |
| First Posted: | December 3, 2009 Key Record Dates |
| Last Update Posted: | March 1, 2011 |
| Last Verified: | February 2010 |
Keywords provided by Istituto Superiore di Sanità:
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HIV Tat protein Preventive vaccine |