HIV Infections Clinical Trial
Official title:
Safety and Immunogenicity Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.
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.
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
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