A Phase I, Open Label, Safety and Immunogenicity Vaccine Trial Based on the Association of Recombinant HIV-1 Biologically Active Tat and V2-deleted Env Proteins in HIV Uninfected Healthy Adult Volunteers.

NCT01441193 Phase 1 TERMINATED

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.

Details

Lead sponsor	Barbara Ensoli, MD
Phase	Phase 1
Status	TERMINATED
Enrolment	11
Start date	2011-09
Completion	2014-02

Conditions

• HIV Infection

Interventions

• HIV-1 Tat/delta-V2 Env combined vaccine
• HIV-1 delta-V2 Env vaccine
• HIV-1 Tat vaccine 7.5 microg
• HIV-1 Tat vaccine 30 microg

Primary outcomes

• Safety and immunogenicity — up to week 68
  To qualify the vaccine candidate as safe and immunogenic by evaluating the number of local and systemic adverse events, including any significant change in hematological/biochemical/coagulation laboratory parameters, and the frequency of anti-Tat and anti-delta-V2 Env humoral and cellular immune responses

Countries

Italy