A Trial to Evaluate Ad35-GRIN/ENV HIV Vaccine in Healthy Adult Volunteers

Phase 1

Completed

• Conditions: HIV; HIV Infections
• Interventions: Biological: Ad35-GRIN/ENV; Biological: Ad35-GRIN

• Registration Number: NCT00851383
• Lead Sponsor: International AIDS Vaccine Initiative

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of Ad35-GRIN/ENV HIV vaccine and Ad35-GRIN HIV vaccine administered intramuscularly at 0 and 6 months.

Detailed Description

This study is a phase I dose-escalation randomized, placebo-controlled study designed to evaluate the safety and immunogenicity of Ad35-GRIN and Ad35-ENV filled in the same vial and administered as a single, combined vaccine. This is the first administration of this vaccine in humans. The study will be double blind with respect to vaccine or placebo. The vaccine will be administered intramuscularly at months 0 and 6 at three dose levels: 2 x 10\^9, 2 x 10\^10, and 2 x 10\^11 vp per dose. Volunteers will be randomized to vaccine: placebo in a 10:4 ratio in each group. A fourth group was added as a protocol amendment to study Ad35-GRIN HIV vaccine alone at 1x10\^10 vp in 14 volunteers (10:4 vaccine:placebo).

Volunteers will be screened up to 42 days before vaccination (90 days for Ad35 neutralizing antibody screening) and will be followed for 12 months after the last vaccination (18 months total study participation). Estimated enrollment will take approximately 5 months. Thus, the total duration of the study would be approximately 23 months.

Study Timeline

• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Study Start: 2009-03
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-23
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Ad35-GRIN/ENV	Ad35-GRIN/ENV: 2x10\^10 vp
Group C	Ad35-GRIN/ENV	Ad35-GRIN/ENV: 2x10\^11 vp
Group D	Ad35-GRIN	Ad35-GRIN at 1x10\^10 vp
Group A	Ad35-GRIN/ENV	Ad35-GRIN/ENV: 2x10\^9 vp

Primary Outcome Measures

Name	Time	Method
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)	18 months

Secondary Outcome Measures

Name	Time	Method
Immunogenicity: Proportion of volunteers with HIV-1 specific T-cell responses by ELISPOT assay.	18 months

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States