Fig. 2

Flow diagram. The study was a randomized, observer-blinded, placebo-controlled study of killed-whole HIV-1 vaccine (SAV001-H) with or without adjuvant administered intramuscularly. Patients were screened for participation in this study within 28 days before enrollment. A total of 33 patients were planned to be enrolled in this study and randomized into Groups 1 and 2 of 17 and 16 patients, respectively. Patients were randomly assigned in a 9:3 ratio to receive either a single injection of the active investigational product or placebo, each of which was administered either without (Group 1) or with (Group 2) adjuvant