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Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of rAAV1-PG9DP when administered intramuscularly at different dose levels in healthy male adults.


Clinical Trial Description

This study is a phase 1, randomized, blinded, dose-escalation study to evaluate the safety and tolerability of rAAV1-PG9DP when administered intramuscularly at 4x10^12 vg, 4x10^13 vg, 8x10^13 vg and 1.2x10^14 vg in healthy male adults.

Volunteers will be screened up to 42 days before injection and will be followed for 12 months after the single administration. It is anticipated that it will take approximately 13 months to enroll the study.

Volunteers will be randomly assigned investigational product (IP) or placebo within each of the dose groups described in the study design table above depending on which group is enrolling. Study staff and volunteers will be blinded only with respect to the allocation of placebo or IP. Blinding will not apply to the assignment of dosage levels.

Volunteers will be offered enrollment into a follow-up study at the research center when they have finished participating in the trial ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01937455
Study type Interventional
Source International AIDS Vaccine Initiative
Contact
Status Active, not recruiting
Phase Phase 1
Start date September 2014
Completion date February 2018

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