title: Phase I safety and immunogenicity trial of Plasmodium vivax CS derived long synthetic peptides adjuvanted with montanide ISA 720 or montanide ISA 51.
abstract: We assessed the safety, tolerability, and immunogenicity of a mixture of three synthetic peptides derived from the Plasmodium vivax circumsporozoite protein formulated in Montanide ISA 720 or Montanide ISA 51. Forty healthy malaria-naive volunteers were allocated to five experimental groups (A-E): four groups (A-D) were immunized intramuscularly with 50 and 100 μg/dose injections of a mixture of N, R, and C peptides formulated in the two different adjuvants at 0, 2, and 4 months and one group was administered placebo. Vaccines were immunogenic, safe, well tolerated, and no serious adverse events related to the vaccine occurred. Seroconversion occurred in > 90% of the vaccines and antibodies recognized the sporozoite protein on immunofluorescent antibody test. Vaccines in Montanide ISA 51 showed a higher sporozoite protein recognition and interferon production. Results encourage further testing of the vaccine protective efficacy.
authors.affiliation: Instituto de Inmunología, Facultad de Salud, Universidad del Valle, Cali, Colombia. sherrera@inmuno.org
authors.forename: Sócrates
authors.initials: S
authors.lastname: Herrera
authors.forename: Olga Lucía
authors.initials: OL
authors.lastname: Fernández
authors.forename: Omaira
authors.initials: O
authors.lastname: Vera
authors.forename: William
authors.initials: W
authors.lastname: Cárdenas
authors.forename: Oscar
authors.initials: O
authors.lastname: Ramírez
authors.forename: Ricardo
authors.initials: R
authors.lastname: Palacios
authors.forename: Mario
authors.initials: M
authors.lastname: Chen-Mok
authors.forename: Giampietro
authors.initials: G
authors.lastname: Corradin
authors.forename: Myriam
authors.initials: M
authors.lastname: Arévalo-Herrera
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000818:Animals; D000913:Antibodies, Protozoan / Q000097:blood; D004306:Dose-Response Relationship, Immunologic; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007273:Injections, Intramuscular; D007371:Interferon-gamma / Q000378:metabolism; D007963:Leukocytes, Mononuclear / Q000378:metabolism; D017780:Malaria Vaccines / Q000009:adverse effects / Q000276:immunology*; D016780:Malaria, Vivax / Q000517:prevention & control*; D008297:Male; D008353:Mannitol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D009829:Oleic Acids / Q000008:administration & dosage*; D010966:Plasmodium vivax / Q000276:immunology*; D015800:Protozoan Proteins / Q000276:immunology*; D013997:Time Factors
chemical_list: D000276:Adjuvants, Immunologic; D000913:Antibodies, Protozoan; D007074:Immunoglobulin G; D017780:Malaria Vaccines; D009829:Oleic Acids; D015800:Protozoan Proteins; C041595:circumsporozoite protein, Protozoan; C477385:montanide ISA 51; C001681:mannide monooleate; D008353:Mannitol; D007371:Interferon-gamma