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

被引：46

作者：

Ellis, Ruth D. ^{[1
]}

Mullen, Gregory E. D. ^{[1
]}

Pierce, Mark ^{[1
]}

Martin, Laura B. ^{[1
]}

Miura, Kazutoyo ^{[1
]}

Fay, Michael P. ^{[2
]}

Long, Carole A. ^{[3
]}

Shaffer, Donna ^{[4
]}

Saul, Allan ^{[1
]}

Miller, Louis H. ^{[1
]}

Durbin, Anna P. ^{[4
]}

机构：

[1] NIAID, Malaria Vaccine Dev Branch, NIH, Rockville, MD 20852 USA

[2] NIAID, Biostat Res Branch, NIH, Rockville, MD 20852 USA

[3] NIAID, Lab Malaria & Vector Res, NIH, Rockville, MD 20852 USA

[4] Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD USA

来源：

VACCINE | 2009年 / 27卷 / 31期

基金：

美国国家卫生研究院;

关键词：

Malaria; Falciparum; Apical membrane antigen 1; APICAL MEMBRANE ANTIGEN-1; ANTIBODY-PRODUCTION; NORMAL VOLUNTEERS; IN-VITRO; TRIAL; CHILDREN; EFFICACY; PROTECTION; CPG-7909; IMMUNITY;

D O I：

10.1016/j.vaccine.2009.04.077

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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). Published by Elsevier Ltd.

引用

页码：4104 / 4109

页数：6

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