A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel® with CPG 7909, using two different formulations and dosing intervals

TY - JOUR

T1 - A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel® with CPG 7909, using two different formulations and dosing intervals

AU - Ellis, Ruth D.

AU - Mullen, Gregory

AU - Pierce, Mark

AU - Martin, Laura B.

AU - Miura, Kazutoyo

AU - Fay, Michael P.

AU - Long, Carole A.

AU - Shaffer, Donna

AU - Saul, Allan

AU - Miller, Louis H.

AU - Durbin, Anna P.

PY - 2009/6/24

Y1 - 2009/6/24

N2 - A Phase 1 study was conducted in 24 malaria naive adults to assess the safety and immunogenicity of the recombinant protein vaccine apical membrane antigen 1-Combination 1 (AMA1-C1)/Alhydrogel with CPG 7909 in two different formulations (phosphate buffer and saline), and given at two different dosing schedules, 0 and 1 month or 0 and 2 months. Both formulations were well tolerated and frequency of local reactions and solicited adverse events was similar among the groups. Peak antibody levels in the groups receiving CPG 7909 in saline were not significantly different than those receiving CPG 7909 in phosphate. Peak antibody levels in the groups vaccinated at a 0,2 month interval were 2.52-fold higher than those vaccinated at a 0,1 month interval (p=0.037, 95% CI 1.03, 4.28). In vitro growth inhibition followed the antibody level: median inhibition was 51% (0,1 month interval) versus 85%(0,2 month interval) in antibody from samples taken 2 weeks post-second vaccination (p = 0.056).

AB - A Phase 1 study was conducted in 24 malaria naive adults to assess the safety and immunogenicity of the recombinant protein vaccine apical membrane antigen 1-Combination 1 (AMA1-C1)/Alhydrogel with CPG 7909 in two different formulations (phosphate buffer and saline), and given at two different dosing schedules, 0 and 1 month or 0 and 2 months. Both formulations were well tolerated and frequency of local reactions and solicited adverse events was similar among the groups. Peak antibody levels in the groups receiving CPG 7909 in saline were not significantly different than those receiving CPG 7909 in phosphate. Peak antibody levels in the groups vaccinated at a 0,2 month interval were 2.52-fold higher than those vaccinated at a 0,1 month interval (p=0.037, 95% CI 1.03, 4.28). In vitro growth inhibition followed the antibody level: median inhibition was 51% (0,1 month interval) versus 85%(0,2 month interval) in antibody from samples taken 2 weeks post-second vaccination (p = 0.056).

U2 - 10.1016/j.vaccine.2009.04.077

DO - 10.1016/j.vaccine.2009.04.077

M3 - Article

SN - 0264-410X

VL - 27

SP - 4104

EP - 4109

JO - Vaccine

JF - Vaccine

IS - 31

ER -