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

Autor: Arévalo-Herrera M; Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia.; Caucaseco Scientific Research Center, Cali, Colombia., Gaitán X; Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia., Larmat-Delgado M; Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia., Caicedo MA; Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia., Herrera SM; Caucaseco Scientific Research Center, Cali, Colombia., Henao-Giraldo J; Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia., Castellanos A; Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia., Devaud JC; Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland., Pannatier A; Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland., Oñate J; Centro Médico Imbanaco, Cali, Colombia., Corradin G; Biochemistry Department, University of Lausanne, Epalinges, Switzerland., Herrera S; Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia. sherrera@inmuno.org.; Caucaseco Scientific Research Center, Cali, Colombia. sherrera@inmuno.org.
Jazyk: angličtina
Zdroj: Nature communications [Nat Commun] 2022 Mar 25; Vol. 13 (1), pp. 1603. Date of Electronic Publication: 2022 Mar 25.
DOI: 10.1038/s41467-022-29226-3
Abstrakt: 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 NCT02083068. This trial was funded by Colciencias (grant 529-2009), NHLBI (grant RHL086488 A), and MVDC/CIV Foundation (grant 2014-1206).
(© 2022. The Author(s).)
Databáze: MEDLINE
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