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Safety, immunogenicity and duration of protection of the RTS,S/ASO2D malaria vaccine: One year follow-up of a randomized controlled phase I/IIb trial

Aide, Pedro, Aponte, John J., Renom, Montse, Nhampossa, Tacilta, Sacarlal, Jahit, Mandomando, Inacio, Bassat, Quique, Manaca, Maria Nelia, Leach, Amanda J., Lievens, Marc, Vekemans, Johan, Dubois, Marie-Claude, Loucq, Christian, Ballou, W. Ripley, Cohen, Joe and Alonso, Pedro L. (2010). Safety, immunogenicity and duration of protection of the RTS,S/ASO2D malaria vaccine: One year follow-up of a randomized controlled phase I/IIb trial. PLoS One,5(11):e13838-1-e13838-9.

Document type: Journal Article
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IRMA ID 75039815xPUB516
Title Safety, immunogenicity and duration of protection of the RTS,S/ASO2D malaria vaccine: One year follow-up of a randomized controlled phase I/IIb trial
Author Aide, Pedro
Aponte, John J.
Renom, Montse
Nhampossa, Tacilta
Sacarlal, Jahit
Mandomando, Inacio
Bassat, Quique
Manaca, Maria Nelia
Leach, Amanda J.
Lievens, Marc
Vekemans, Johan
Dubois, Marie-Claude
Loucq, Christian
Ballou, W. Ripley
Cohen, Joe
Alonso, Pedro L.
Journal Name PLoS One
Publication Date 2010
Volume Number 5
Issue Number 11
ISSN 1932-6203   (check CDU catalogue  open catalogue search in new window)
Scopus ID 2-s2.0-78149488576
Start Page e13838-1
End Page e13838-9
Total Pages 9
Place of Publication United States
Publisher Public Library of Science
HERDC Category C1 - Journal Article (DIISR)
Abstract 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/AS02D 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/AS02D, remaining 15-fold higher than in the control group. Vaccine efficacy against clinical malaria was 33% (95% CI: −4.3–56.9, 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/AS02D 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.
DOI http://dx.doi.org/10.1371/journal.pone.0013838   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)


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