A field trial to assess a blood-Stage malaria vaccine
M.A. Thera
(1, 2)
,
O.K. Doumbo
(1, 2)
,
Drissa Coulibaly
(1)
,
Matthew Laurens
(1)
,
Amed Ouatara
(1)
,
A.K. Kone,
(1, 2)
,
Ando B. Guindo
(1)
,
A.A. Djimbé
(1, 2)
,
K. Traoré
(1, 2, 3)
,
Idrissa Traoré
(1)
,
Dapa A. Diallo
(1)
,
Et Al.
Résumé
BACKGROUND--Blood-stage malaria vaccines are intended to prevent clinical disease. The malaria vaccine FMP2.1/AS02A, a recombinant protein based on apical membrane antigen 1 (AMA1) from the 3D7 strain of Plasmodium falciparum, has previously been shown to have immunogenicity and acceptable safety in Malian adults and children. METHODS--In a double-blind, randomized trial, we immunized 400 Malian children with either the malaria vaccine or a control (rabies) vaccine and followed them for 6 months. The primary end point was clinical malaria, defined as fever and at least 2500 parasites per cubic millimeter of blood. A secondary end point was clinical malaria caused by parasites with the AMA1 DNA sequence found in the vaccine strain. RESULTS--The cumulative incidence of the primary end point was 48.4% in the malariavaccine group and 54.4% in the control group; efficacy against the primary end point was 17.4% (hazard ratio for the primary end point, 0.83; 95% confidence interval [CI], 0.63 to 1.09; P = 0.18). Efficacy against the first and subsequent episodes of clinical malaria, as defined on the basis of various parasite-density thresholds, was approximately 20%. Efficacy against clinical malaria caused by parasites with AMA1 corresponding to that of the vaccine strain was 64.3% (hazard ratio, 0.36; 95% CI, 0.08 to 0.86; P = 0.03). Local reactions and fever after vaccination were more frequent with the malaria vaccine. CONCLUSIONS--On the basis of the primary end point, the malaria vaccine did not provide significant protection against clinical malaria, but on the basis of secondary results, it may have strain-specific efficacy. If this finding is confirmed, AMA1 might be useful in a multicomponent malaria vaccine.
Format du dépôt | Notice |
---|---|
Type de dépôt | Article dans une revue |
Titre |
en
A field trial to assess a blood-Stage malaria vaccine
|
Résumé |
en
BACKGROUND--Blood-stage malaria vaccines are intended to prevent clinical disease. The malaria vaccine FMP2.1/AS02A, a recombinant protein based on apical membrane antigen 1 (AMA1) from the 3D7 strain of Plasmodium falciparum, has previously been shown to have immunogenicity and acceptable safety in Malian adults and children. METHODS--In a double-blind, randomized trial, we immunized 400 Malian children with either the malaria vaccine or a control (rabies) vaccine and followed them for 6 months. The primary end point was clinical malaria, defined as fever and at least 2500 parasites per cubic millimeter of blood. A secondary end point was clinical malaria caused by parasites with the AMA1 DNA sequence found in the vaccine strain. RESULTS--The cumulative incidence of the primary end point was 48.4% in the malariavaccine group and 54.4% in the control group; efficacy against the primary end point was 17.4% (hazard ratio for the primary end point, 0.83; 95% confidence interval [CI], 0.63 to 1.09; P = 0.18). Efficacy against the first and subsequent episodes of clinical malaria, as defined on the basis of various parasite-density thresholds, was approximately 20%. Efficacy against clinical malaria caused by parasites with AMA1 corresponding to that of the vaccine strain was 64.3% (hazard ratio, 0.36; 95% CI, 0.08 to 0.86; P = 0.03). Local reactions and fever after vaccination were more frequent with the malaria vaccine. CONCLUSIONS--On the basis of the primary end point, the malaria vaccine did not provide significant protection against clinical malaria, but on the basis of secondary results, it may have strain-specific efficacy. If this finding is confirmed, AMA1 might be useful in a multicomponent malaria vaccine.
|
Auteur(s) |
M.A. Thera
1, 2
, O.K. Doumbo
1, 2
, Drissa Coulibaly
1
, Matthew Laurens
1
, Amed Ouatara
1
, A.K. Kone,
1, 2
, Ando B. Guindo
1
, A.A. Djimbé
1, 2
, K. Traoré
1, 2, 3
, Idrissa Traoré
1
, Dapa A. Diallo
1
, Et Al.
1
Département d'Epidémiologie des Affections parasitaires, Malaria Research and training center Université de Bamako, Mali
( 187496 )
- Faculté de Médecine et d'Odonto-stomatologie BP 1805 Point G, Bamako
- Mali
2
ESS -
Environnement, Santé, Sociétés
( 105430 )
- France
3
LPCTM -
Laboratoire de Physico-Chimie et de Technologie des Matériaux
( 171094 )
- Département de Chimie, UFR Sciences Exactes et Appliquées, Université de Ouagadougou, BP 7021, Burkina Faso
- Burkina Faso
|
Comité de lecture |
Oui
|
Vulgarisation |
Non
|
Langue du document |
Anglais
|
Nom de la revue |
|
Audience |
Non spécifiée
|
Date de publication |
2011-09-15
|
Volume |
365
|
Numéro |
11
|
Page/Identifiant |
1004-1013
|
Domaine(s) |
|
Mots-clés |
it
Malaria vaccine
|
DOI | 10.1056/NEJMoa1008115 |
PubMed Central | PMC3242358 |
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