Figure 1.
CONSORT diagram for study participants.
176 failed eligibility criteria: 13 outside age range [18–35]; 9 not available for the whole study duration (12 months); 44 not free of obvious health problem (med history/clin exam); 14 female of childbearing potential not using adequate contraceptives; 8 confirmed or suspected HIV; 10 acute disease at time of enrolment; 27 acute or chronic clinically significant pulmonary, cardiovascular hepatic or renal functional abnormality; 6 ALT outside range; 15 hemoglobin outside range; 9 history of chronic alcohol/drug use; 21 other (including pregnant, administration of IG/blood products, sickle cell disease, HBsAg positive, other safety labs outside range, history of seizures, or allergic reactions, planned administration of non-study vaccine). Note: Underlying medical conditions were not detected at screening. ADI: active detection of infection. * These subjects did not complete ADI assessments, but were followed up for safety assessments and appear in the total of completed single-blind phase.
Figure 2.
ADI = active detection of infection. CS = circumsporozoite protein.
Table 1.
Baseline characteristics and distribution of covariates of study participants (Total vaccinated cohort).
Table 2.
Incidence of solicited local and general adverse events within 7 days per dose and overall per dose (Total vaccinated cohort).
Figure 3.
Anti-CS GMTs over time (ATP cohort for immunogenicity).
Note: bars represent 95% confidence intervals.
Table 3.
Seropositivity rates, seroprotection rates and GMTs for anti-HBs antibodies by vaccine group (ATP cohort for immunogenicity).
Figure 4.
Vaccine Efficacy: reverse cumulative curve showing the time to infection with malaria by vaccine group (ATP cohort for efficacy).
Gr 1 = RTS,S/AS01B; Gr 2 = RTS,S/AS02A; Gr 3 = Rabies; Day 0 = 14 days post Dose 3; ADI = Active Detection of Infection.
Table 4.
Vaccine efficacy against P. falciparum infection (ATP cohort for efficacy).
Figure 5.
Anti-CS GMTs during efficacy surveillance by infection status (ATP cohort for efficacy).