Phase I Safety and Immunogenicity Preventative Vaccine Trial Based on Recombinant Tat Protein

NCT00529698 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-03-01

No results posted yet for this study

Summary

This Phase I study is directed at evaluating the safety profile (as a primary end-point) and the immunogenicity (as a secondary end-point) of the recombinant HIV-1 Tat vaccine in healthy, immunologically competent adult subjects without identifiable risk of HIV-1 infection.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Biologically active recombinant Tat protein

Sponsors & Collaborators

  • Istituto Superiore di Sanità

    lead OTHER

Principal Investigators

  • Barbara Ensoli, MD, PhD · National AIDS Center, Istituto Superiore di Sanita, Rome, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-01-31
Completion
2007-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00529698 on ClinicalTrials.gov