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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Safety, immunogenicity and duration of protection of the RTS,S/ASO2
D
malaria vaccine: One year follow-up of a randomized controlled phase I/IIb trial
PLoS ONE, Volume 5, No. 11, Article e13838, Year 2010
Notification
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Description
Background: The RTS,S/AS02D vaccine has been shown to have a promising safety profile, to be immunogenic and to confer protection against malaria in children and infants. Methods and Findings: We did a randomized, controlled, phase I/IIb trial of RTS,S/AS02D given at 10, 14 and 18 weeks of age staggered with routine immunization vaccines in 214 Mozambican infants. The study was double-blind until the young child completed 6 months of follow-up over which period vaccine efficacy against new Plasmodium falciparum infections was estimated at 65.9% (95% CI 42.6-79.8, p<0.0001). We now report safety, immunogenicity and estimated efficacy against clinical malaria up to 14 months after study start. Vaccine efficacy was assessed using Cox regression models. The frequency of serious adverse events was 32.7% in the RTS,S/ASO2D and 31.8% in the control group. The geometric mean titers of anti-circumsporozoite antibodies declined from 199.9 to 7.3 EU/mL from one to 12 months post dose three of RTS,S/ASO2D, remaining 15-fold higher than in the control group. Vaccine efficacy against clinical malaria was 33% (95% CI: 24.3-56.9, p = 0.076) over 14 months of follow-up. The hazard rate of disease per 2-fold increase in anti-CS titters was reduced by 84% (95% CI 35.1-88.2, p = 0.003). Conclusion: The RTS,S/ASO2D malaria vaccine administered to young infants has a good safety profile and remains efficacious over 14 months. A strong association between anti-CS antibodies and risk of clinical malaria has been described for the first time. The results also suggest a decrease of both anti-CS antibodies and vaccine efficacy over time. © 2010 Aide et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2973956/bin/pone.0013838.s001.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC2973956/bin/pone.0013838.s002.rtf
Authors & Co-Authors
Aíde, Pedro
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Instituto Nacional de Saude Maputo
Aponte, John Jairo
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Instituto de Salud Global de Barcelona
Renom, Montse
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Instituto de Salud Global de Barcelona
Nhampossa, Tacilta
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Instituto Nacional de Saude Maputo
Sacarlal, J.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Universidade Eduardo Mondlane
Mandomando, Inácio M.
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Mozambique, Maputo
Instituto Nacional de Saude Maputo
Bassat, Quique
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Instituto de Salud Global de Barcelona
Manaca, Maria Nélia
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Leach, Amanda
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Lievens, Marc J.J.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Vekemans, Johan
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Dubois, Marie Claude
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Loucq, Christian
United States, Bethesda
Path Malaria Vaccine Initiative
Ballou, William Ripley
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Cohen, Joe D.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Alonso, Pedro Luís
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Spain, Barcelona
Instituto de Salud Global de Barcelona
Statistics
Citations: 43
Authors: 16
Affiliations: 6
Identifiers
Doi:
10.1371/journal.pone.0013838
e-ISSN:
19326203
Research Areas
Disability
Environmental
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Cohort Study