Randomized clinical trial to assess the protective efficacy of a Plasmodium vivax CS synthetic vaccine

Myriam Arévalo-Herrera, Xiomara Gaitán, Michelle Larmat-Delgado, María Alejandra Caicedo, Sonia M. Herrera, Juliana Henao-Giraldo, Angélica Castellanos, Jean-Christophe Devaud, André Pannatier, José Oñate, Giampietro Corradin and Sócrates Herrera ()
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Myriam Arévalo-Herrera: Malaria Vaccine and Drug Development Center (MVDC)
Xiomara Gaitán: Malaria Vaccine and Drug Development Center (MVDC)
Michelle Larmat-Delgado: Malaria Vaccine and Drug Development Center (MVDC)
María Alejandra Caicedo: Malaria Vaccine and Drug Development Center (MVDC)
Sonia M. Herrera: Caucaseco Scientific Research Center
Juliana Henao-Giraldo: Malaria Vaccine and Drug Development Center (MVDC)
Angélica Castellanos: Malaria Vaccine and Drug Development Center (MVDC)
Jean-Christophe Devaud: Centre Hospitalier Universitaire Vaudois
André Pannatier: Centre Hospitalier Universitaire Vaudois
José Oñate: Centro Médico Imbanaco
Giampietro Corradin: University of Lausanne
Sócrates Herrera: Malaria Vaccine and Drug Development Center (MVDC)

Nature Communications, 2022, vol. 13, issue 1, 1-10

Abstract: Abstract A randomized, double-blind, controlled vaccine clinical trial was conducted to assess, as the primary outcome, the safety and protective efficacy of the Plasmodium vivax circumsporozoite (CS) protein in healthy malaria-naïve (phase IIa) and semi-immune (phase IIb) volunteers. Participants (n = 35) were randomly selected from a larger group (n = 121) and further divided into naïve (n = 17) and semi-immune (n = 18) groups and were immunized at months 0, 2, and 6 with PvCS formulated in Montanide ISA-51 adjuvant or placebo (adjuvant alone). Specific antibodies and IFN-γ responses to PvCS were determined as secondary outcome; all experimental volunteers developed specific IgG and IFN-γ. Three months after the last immunization, all participants were subjected to controlled human malaria infection. All naive controls became infected and drastic parasitemia reduction, including sterile protection, developed in several experimental volunteers in phase IIa (6/11) (54%, 95% CI 0.25–0.84) and phase IIb (7/11) (64%, 95% CI 0.35–0.92). However, no difference in parasitemia was observed between the phase IIb experimental and control subgroups. In conclusion, this study demonstrates significant protection in both naïve and semi-immune volunteers, encouraging further PvCS vaccine clinical development. Trial registration number NCT 02083068. This trial was funded by Colciencias (grant 529-2009), NHLBI (grant RHL086488 A), and MVDC/CIV Foundation (grant 2014-1206).

Date: 2022
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DOI: 10.1038/s41467-022-29226-3

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