Abstract
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | New England Journal of Medicine |
| Vol/bind | 359 |
| Udgave nummer | 24 |
| Sider (fra-til) | 2521-32 |
| Antal sider | 11 |
| ISSN | 0028-4793 |
| DOI | |
| Status | Udgivet - 2008 |
Bibliografisk note
2008 Massachusetts Medical SocietyAdgang til dokumentet
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I: New England Journal of Medicine, Bind 359, Nr. 24, 2008, s. 2521-32.
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
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TY - JOUR
T1 - Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age
AU - Bejon, Philip
AU - Lusingu, John
AU - Olotu, Ally
AU - Leach, Amanda
AU - Lievens, Marc
AU - Vekemans, Johan
AU - Mshamu, Salum
AU - Lang, Trudie
AU - Gould, Jayne
AU - Dubois, Marie-Claude
AU - Demoitié, Marie-Ange
AU - Stallaert, Jean-Francois
AU - Vansadia, Preeti
AU - Carter, Terrell
AU - Njuguna, Patricia
AU - Awuondo, Ken O
AU - Malabeja, Anangisye
AU - Abdul, Omar
AU - Gesase, Samwel
AU - Mturi, Neema
AU - Drakeley, Chris J
AU - Savarese, Barbara
AU - Villafana, Tonya
AU - Ballou, W Ripley
AU - Cohen, Joe
AU - Riley, Eleanor M
AU - Lemnge, Martha M
AU - Marsh, Kevin
AU - von Seidlein, Lorenz
N1 - Keywords: Animals; Antibodies, Protozoan; Double-Blind Method; Female; Humans; Infant; Kaplan-Meiers Estimate; Malaria Vaccines; Malaria, Falciparum; Male; Plasmodium falciparum; Proportional Hazards Models; Protozoan Proteins
PY - 2008
Y1 - 2008
N2 - BACKGROUND: Plasmodium falciparum malaria is a pressing global health problem. A previous study of the malaria vaccine RTS,S (which targets the circumsporozoite protein), given with an adjuvant system (AS02A), showed a 30% rate of protection against clinical malaria in children 1 to 4 years of age. We evaluated the efficacy of RTS,S given with a more immunogenic adjuvant system (AS01E) in children 5 to 17 months of age, a target population for vaccine licensure. METHODS: We conducted a double-blind, randomized trial of RTS,S/AS01E vaccine as compared with rabies vaccine in children in Kilifi, Kenya, and Korogwe, Tanzania. The primary end point was fever with a falciparum parasitemia density of more than 2500 parasites per microliter, and the mean duration of follow-up was 7.9 months (range, 4.5 to 10.5). RESULTS: A total of 894 children were randomly assigned to receive the RTS,S/AS01E vaccine or the control (rabies) vaccine. Among the 809 children who completed the study procedures according to the protocol, the cumulative number in whom clinical malaria developed was 32 of 402 assigned to receive RTS,S/AS01E and 66 of 407 assigned to receive the rabies vaccine; the adjusted efficacy rate for RTS,S/AS01E was 53% (95% confidence interval [CI], 28 to 69; P<0.001) on the basis of Cox regression. Overall, there were 38 episodes of clinical malaria among recipients of RTS,S/AS01E, as compared with 86 episodes among recipients of the rabies vaccine, with an adjusted rate of efficacy against all malarial episodes of 56% (95% CI, 31 to 72; P<0.001). All 894 children were included in the intention-to-treat analysis, which showed an unadjusted efficacy rate of 49% (95% CI, 26 to 65; P<0.001). There were fewer serious adverse events among recipients of RTS,S/AS01E, and this reduction was not only due to a difference in the number of admissions directly attributable to malaria. CONCLUSIONS: RTS,S/AS01E shows promise as a candidate malaria vaccine. (ClinicalTrials.gov number, NCT00380393.)
AB - BACKGROUND: Plasmodium falciparum malaria is a pressing global health problem. A previous study of the malaria vaccine RTS,S (which targets the circumsporozoite protein), given with an adjuvant system (AS02A), showed a 30% rate of protection against clinical malaria in children 1 to 4 years of age. We evaluated the efficacy of RTS,S given with a more immunogenic adjuvant system (AS01E) in children 5 to 17 months of age, a target population for vaccine licensure. METHODS: We conducted a double-blind, randomized trial of RTS,S/AS01E vaccine as compared with rabies vaccine in children in Kilifi, Kenya, and Korogwe, Tanzania. The primary end point was fever with a falciparum parasitemia density of more than 2500 parasites per microliter, and the mean duration of follow-up was 7.9 months (range, 4.5 to 10.5). RESULTS: A total of 894 children were randomly assigned to receive the RTS,S/AS01E vaccine or the control (rabies) vaccine. Among the 809 children who completed the study procedures according to the protocol, the cumulative number in whom clinical malaria developed was 32 of 402 assigned to receive RTS,S/AS01E and 66 of 407 assigned to receive the rabies vaccine; the adjusted efficacy rate for RTS,S/AS01E was 53% (95% confidence interval [CI], 28 to 69; P<0.001) on the basis of Cox regression. Overall, there were 38 episodes of clinical malaria among recipients of RTS,S/AS01E, as compared with 86 episodes among recipients of the rabies vaccine, with an adjusted rate of efficacy against all malarial episodes of 56% (95% CI, 31 to 72; P<0.001). All 894 children were included in the intention-to-treat analysis, which showed an unadjusted efficacy rate of 49% (95% CI, 26 to 65; P<0.001). There were fewer serious adverse events among recipients of RTS,S/AS01E, and this reduction was not only due to a difference in the number of admissions directly attributable to malaria. CONCLUSIONS: RTS,S/AS01E shows promise as a candidate malaria vaccine. (ClinicalTrials.gov number, NCT00380393.)
U2 - 10.1056/NEJMoa0807381
DO - 10.1056/NEJMoa0807381
M3 - Journal article
C2 - 19064627
SN - 0028-4793
VL - 359
SP - 2521
EP - 2532
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 24
ER -