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1762462 
Journal Article 
Safety and Immunogenicity of the Malaria Vaccine Candidate MSP3 Long Synthetic Peptide in 12-24 Months-Old Burkinabe Children 
Sirima, SB; Tiono, AB; Ouedraogo, A; Diarra, A; Ouedraogo, ALin; Yaro, JB; Ouedraogo, E; Gansane, A; Bougouma, EC; Konate, AT; Kabore, Y; Traore, A; Roma, C; Soulama, I; Luty, AJF; Cousens, S; Nebie, I 
2009 
1 
PLoS ONE
EISSN: 1932-6203 
4 
10 
19855847 
WOS:000271147200004 
Background: A Phase Ia trial in European volunteers of the
candidate vaccine merozoite surface protein 3 (MSP3), a Plasmodium falciparum blood stage
membrane, showed that it induces biologically active antibodies able to achieve parasite killing
in vitro, while a phase Ib trial in semi-immune adult volunteers in Burkina Faso confirmed that
the vaccine was safe. The aim of this study was to assess the safety and immunogenicity of this
vaccine candidate in children aged 12 24 months living in malaria endemic area of Burkina Faso.
Methods: The study was a double-blind, randomized, controlled, dose escalation phase Ib trial,
designed to assess the safety, reactogenicity and immunogenicity of three doses of either 15 or
30 mu g of MSP3-LSP adsorbed on aluminum hydroxide in 45 children 12 to 24 months of age
randomized into three equal groups. Each group received 3 vaccine doses (on days 0, 28 and 56) of
either 15 mu g of MSP3-LSP, 30 mu g of MSP3-LSP or of the Engerix B hepatitis B vaccine. Children
were visited at home daily for the 6 days following each vaccination to solicit symptoms which
might be related to vaccination. Serious adverse events occurring during the study period (1
year) were recorded. Antibody responses to MSP3-LSP were measured on days 0, 28, 56 and 84.
Results: All 45 enrolled children received three MSP3 vaccine doses. No serious adverse events
were reported. Most of the adverse events reported were mild to moderate in severity. The only
reported local symptoms with grade 3 severity were swelling and induration, with an apparently
dose related response. All grade 3 adverse events resolved without any sequelae. Both MSP3 doses
regimens were able to elicit high levels of anti-MSP3 specific IgG1 and IgG3 antibodies in the
volunteers with very little or no increase in IgG2, IgG4 and IgM classes: i.e. vaccination
induced predominantly the isotypes involved in the monocyte-dependent mechanism of P. falciparum
parasite-killing. Conclusion: Our results support the promise of MSP3-LSP as a malaria vaccine
candidate, both in terms of tolerability and of immunogenicity. Further assessment of the
efficacy of this vaccine is recommended.