NCT01937455

A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.

Safety and Immunogenicity Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	rAAV1-PG9DP	4x10\^12 vg administered intramuscularly
BIOLOGICAL	rAAV1-PG9DP	4x10\^13 vg administered intramuscularly
BIOLOGICAL	rAAV1-PG9DP	8x10\^13 vg administered intramuscularly
BIOLOGICAL	rAAV1-PG9DP	1.2x10\^14 vg administered intramuscularly

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2013-09-09
• Last updated: 2018-01-11

Locations

2 sites across 1 country: United Kingdom