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9 saline. All study interventions were administered intramuscularly. The primary endpoints were safety and tolerability of the vaccination regimens and Env-specific binding antibody responses at week 28. Safety and immunogenicity were also evaluated at week 52. All participants who received least one dose of vaccine or placebo were included in the safety analysis. Immunogenicity was analyzed using the per protocol apiclof. A parallel study was also performed in rhesus monkeys NHP 13-19 to evaluate the immunogenicity and protective efficacy of these regimens against a series of six repetitive and heterologous intrarectal challenges with a stock of simian-human immunodeficiency virus SHIV-SF162P3.
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