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A Phase I Safety and Immunogenicity Preventive Vaccine Trial Based on the HIV-1 Tat and V2-deleted Env Proteins (ISS P-002)

NCT01441193 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-03-04

No results posted yet for this study

Summary

This Phase I study was directed at evaluating the safety profile and the immunogenicity of the vaccination with recombinant HIV-1 Tat and V2-deleted Env (delta-V2 Env) proteins administered in association in healthy, immunologically competent adults, compared to delta-V2 Env or Tat alone.

Conditions

  • HIV Infection

Interventions

BIOLOGICAL

HIV-1 Tat/delta-V2 Env combined vaccine

BIOLOGICAL

HIV-1 delta-V2 Env vaccine

BIOLOGICAL

HIV-1 Tat vaccine 7.5 microg

BIOLOGICAL

HIV-1 Tat vaccine 30 microg

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Barbara Ensoli, MD

    lead OTHER

Principal Investigators

  • Barbara Ensoli, MD · Istituto Superiore di Sanità

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-02-28
Completion
2014-02-28

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 NCT01441193 on ClinicalTrials.gov