MOESM1 of Phase 1 randomized controlled trial to evaluate the safety and immunogenicity of recombinant Pichia pastoris-expressed Plasmodium falciparum apical membrane antigen 1 (PfAMA1-FVO [25-545]) in healthy Malian adults in Bandiagara

Additional file 1. Raw data set of the IgG and GIA responses for the phase 1 trial of PfAMA1 FVO [25-545] in Malians adults in Bandiagara

Anemia experienced by all subjects (months 0–24, all randomized participants).

<p>Data are reported as incidence of participants with at least one episode of anemia per 100 person-years at risk (PYAR) with 95% confidence intervals (incidence per PYAR [95% confidence interval]) among participants given at least one dose of vaccine. Based on 331.2 PYAR for FMP2.1/AS02_A group and 331.9 PYAR for control group. *P<0.05.</p

Vaccine efficacy against first episode of clinical malaria with apical membrane antigen 1 (AMA1) cluster 1 loop (c1L) identical to the vaccine strain 3D7 during the entire follow-up period (study days 0–730), intention-to-treat.

<p>Vaccine efficacy against first episode of clinical malaria with apical membrane antigen 1 (AMA1) cluster 1 loop (c1L) identical to the vaccine strain 3D7 during the entire follow-up period (study days 0–730), intention-to-treat.</p

Serious adverse events experienced by all subjects (months 0–24, all randomized participants).

<p>Data are reported as: Number of participants with a serious adverse event (% [95% confidence interval]) among participants given at least one dose of vaccine.</p

Allele-specific vaccine efficacy against <i>P. falciparum</i> malaria, intention-to-treat cohort.

<p>PYAR, Person Years At Risk. CI, confidence interval. ND, not done.</p>*<p>Efficacy was calculated as 1– hazard ratio obtained using Cox proportional hazards modeling.</p>†<p>Rate of malaria episodes per person-year at risk.</p>‡<p>Efficacy was calculated as 1– risk ratio obtained using Poisson regression.</p

Levels of anti-apical membrane antigen 1 (AMA1) antibody to homologous recombinant AMA1 for FMP2.1/AS02_A vaccine and rabies vaccine recipients during the entire follow-up period (study days 0–730).

<p>Error bars indicate 95% confidence intervals.</p

Disposition of study participants.

<p>Disposition of study participants.</p