A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali

被引：151

作者：

Sagara, Issaka ^{[1
]}

Dicko, Alassane ^{[1
]}

Ellis, Ruth D. ^{[2
]}

Fay, Michael P. ^{[3
]}

Diawara, Sory I. ^{[1
]}

Assadou, Mahamadoun H. ^{[1
]}

Sissoko, Mahamadou S. ^{[1
]}

Kone, Mamady ^{[1
]}

Diallo, Abdoulbaki I. ^{[1
]}

Saye, Renion ^{[1
]}

Guindo, Merepen A. ^{[1
]}

Kante, Ousmane ^{[1
]}

Niambele, Mohamed B. ^{[1
]}

Miura, Kazutoyo ^{[2
]}

Mullen, Gregory E. D. ^{[2
,6
]}

Pierce, Mark ^{[2
,5
]}

Martin, Laura B. ^{[2
,4
]}

Dolo, Amagana ^{[1
]}

Diallo, Dapa A. ^{[1
]}

Doumbo, Ogobara K. ^{[1
]}

Miller, Louis H. ^{[2
]}

Saul, Allan ^{[2
,4
]}

机构：

[1] Univ Bamako, Malaria Res & Training Ctr, Fac Med Pharm & Dent, Mali, Malaysia

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

[3] NIAID, Biostat Res Branch, NIH, Bethesda, MD USA

[4] Novartis Vaccines Inst Global Hlth Srl, Siena, Italy

[5] Cookeville Reg Med Ctr, Cookeville, TN 38506 USA

[6] St Thomas Hosp, Rayne Inst, Div Imaging Sci, Sch Med,Kings Coll London, London SE1 7EH, England

来源：

VACCINE | 2009年 / 27卷 / 23期

基金：

美国国家卫生研究院;

关键词：

Malaria; Vaccine; AMA1; APICAL MEMBRANE ANTIGEN-1; PLASMODIUM-FALCIPARUM; AMA-1; PROTECTION; CANDIDATE; EFFICACY; MONKEYS;

D O I：

10.1016/j.vaccine.2009.03.014

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

071005 [微生物学]; 100108 [医学免疫学];

摘要：

A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel (R) Participants were healthy children 2-3 years old living in or near the village of Bancoumana. Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/mu L/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin <8.5 g/dL, in the direction of lower hemoglobin in the children who received AMA1-C1, although these differences were not significant after correction for multiple tests. These differences were not seen in the second year of transmission. (C) 2009 Elsevier Ltd. All rights reserved.

引用

页码：3090 / 3098

页数：9

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