HIV Infections Clinical Trial
Official title:
A Phase I Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety and Immunogenicity of a Sendai HIV Vaccine SeV-G(NP) Given Intranasally and Ad35-GRIN Administered Intramuscularly in Prime-Boost Regimens in HIV-Uninfected, Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers.
The study is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing
the safety, tolerability, and immunogenicity of SeV-G(NP) given intranasally by drops and
Ad35-GRIN administered intramuscularly in each of four prime-boost regimens.
Volunteers will be screened up to 42 days before the 1st vaccination and will be followed
for 12 months after the last vaccine administration (16 months after the first vaccination).
It is anticipated that it will take approximately 6 months to enroll the study.
Approximately 64 volunteers (48 vaccine and 16 placebo recipients) will be included in the
study.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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