Safety, immunogenicity and duration of protection of the RTS,S/ASO2 malaria vaccine: One year follow-up of a randomized controlled phase I/IIb trial
PLoS ONE, ISSN: 1932-6203, Vol: 5, Issue: 11, Page: e13838
2010
- 38Citations
- 115Captures
- 1Mentions
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- Citations38
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- 38
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- Captures115
- Readers115
- 115
- Mentions1
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Most Recent News
Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region
STUDY INFORMATION OFFICIAL TITLE: A Phase I/IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02D, a Candidate Malaria Vaccine in Infants
Article Description
Background: The RTS,S/AS02 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/AS02 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/ASO2 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/ASO2, 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/ASO2 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.
Bibliographic Details
10.1371/journal.pone.0013838; 10.1371/journal.pone.0013838.g001; 10.1371/journal.pone.0013838.t002; 10.1371/journal.pone.0013838.g002; 10.1371/journal.pone.0013838.t004; 10.1371/journal.pone.0013838.t001; 10.1371/journal.pone.0013838.t003
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