title: A phase 1, randomized, controlled dose-escalation study of EP-1300 polyepitope DNA vaccine against Plasmodium falciparum malaria administered via electroporation.
abstract: Plasmodium falciparum malaria is one of the leading infectious causes of childhood mortality in Africa. EP-1300 is a polyepitope plasmid DNA vaccine expressing 38 cytotoxic T cell epitopes and 16 helper T cell epitopes derived from P. falciparum antigens expressed predominantly in the liver phase of the parasite's life cycle. We performed a phase 1 randomized, placebo-controlled, dose escalation clinical trial of the EP-1300 DNA vaccine administered via electroporation using the TriGrid Delivery System device (Ichor Medical Systems). Although the delivery of the EP-1300 DNA vaccine via electroporation was safe, tolerability was less than that usually observed with standard needle and syringe intramuscular administration. This was primarily due to acute local discomfort at the administration site during electroporation. Despite the use of electroporation, the vaccine was poorly immunogenic. The reasons for the poor immunogenicity of this polyepitope DNA vaccine remain uncertain.
  
  
  
  ClinicalTrials.gov NCT01169077.
authors.affiliation: Department of Pediatrics and Children's Healthcare of Atlanta, Atlanta, GA, USA. Electronic address: paul.spearman@cchmc.org.
authors.forename: Paul
authors.initials: P
authors.lastname: Spearman
authors.affiliation: Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Mulligan
authors.affiliation: Department of Pediatrics and Children's Healthcare of Atlanta, Atlanta, GA, USA; Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Evan J
authors.initials: EJ
authors.lastname: Anderson
authors.affiliation: Department of Pediatrics and Children's Healthcare of Atlanta, Atlanta, GA, USA; Rollins School of Public Health, Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Andi L
authors.initials: AL
authors.lastname: Shane
authors.affiliation: Department of Pediatrics and Children's Healthcare of Atlanta, Atlanta, GA, USA.
authors.forename: Kathy
authors.initials: K
authors.lastname: Stephens
authors.affiliation: Department of Pediatrics and Children's Healthcare of Atlanta, Atlanta, GA, USA.
authors.forename: Theda
authors.initials: T
authors.lastname: Gibson
authors.affiliation: Department of Pediatrics and Children's Healthcare of Atlanta, Atlanta, GA, USA.
authors.forename: Brooke
authors.initials: B
authors.lastname: Hartwell
authors.affiliation: Ichor Medical Systems, Inc., San Diego, CA, USA.
authors.forename: Drew
authors.initials: D
authors.lastname: Hannaman
authors.affiliation: EMMES Corporation, Rockville, MD, USA.
authors.forename: Nora L
authors.initials: NL
authors.lastname: Watson
authors.affiliation: Department of Pediatrics and Children's Healthcare of Atlanta, Atlanta, GA, USA.
authors.forename: Karnail
authors.initials: K
authors.lastname: Singh
mesh_terms: D000293:Adolescent; D000328:Adult; D000349:Africa; D000913:Antibodies, Protozoan / Q000096:biosynthesis / Q000097:blood; D004306:Dose-Response Relationship, Immunologic; D018274:Electroporation; D018984:Epitopes, T-Lymphocyte / Q000008:administration & dosage / Q000276:immunology; D005260:Female; D006801:Humans; D000071497:Immunogenicity, Vaccine; D017780:Malaria Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D016778:Malaria, Falciparum / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D010963:Plasmodium falciparum / Q000276:immunology; D015800:Protozoan Proteins / Q000276:immunology; D019444:Vaccines, DNA / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology*; D055815:Young Adult
chemical_list: D000913:Antibodies, Protozoan; D018984:Epitopes, T-Lymphocyte; D017780:Malaria Vaccines; D015800:Protozoan Proteins; D019444:Vaccines, DNA
keywords: Electroporation; Malaria; Phase 1; Plasmodium falciparum; Polyepitope DNA vaccine; Vaccine