title: Clinical immunogenicity and tolerance studies of liquid vaccines delivered by jet-injector and a new single-use cartridge (Imule): comparison with standard syringe injection. Imule Investigators Group.
abstract: A new needleless jet-injector, Mini-Imojet, was developed that administers liquid vaccines from a single-use, pre-filled cartridge named Imule, which avoids the risk of cross-contamination. We conducted clinical trials in several settings in France and West Africa to compare the immunogenicity and tolerance of five vaccines (influenza vaccine, Vi capsular polysaccharide typhoid vaccine, tetanus toxoid vaccine, diphtheria-tetanus-whole cell pertussis vaccine, and inactivated hepatitis A vaccine) administered with the Imule system vs standard syringe technique. In each vaccine study, all subjects of either group were tested for serum antibody titres to calculate the geometrical mean titres and seroconversion rates after complete vaccination. Immediate local-reactions were noted after each injection, and local and general reactions were evaluated during a predetermined period of follow-up. When delivered by the Imule technique, all the administered vaccines were of equivalent or superior immunogenicity, compared to the syringe technique. The tolerance to vaccines injected by the Imule system was acceptable in all studies. The most frequently observed reactions were mild (e.g. minor bleeding, superficial papules, erythema and induration) and could be considered to be inherent to the injection technique. The technical and safety advantages of the Mini-Imojet/Imule system, compared to sterilizable, standard disposable or autodestruct syringes and to classical multi-dose vial jet-injectors, reinforces the interest of this new injection technique for collective immunizations.
authors.affiliation: Pasteur-Mérieux Sérums et Vaccins, Lyon, France.
authors.forename: I
authors.initials: I
authors.lastname: Parent du Châtelet
authors.forename: J
authors.initials: J
authors.lastname: Lang
authors.forename: M
authors.initials: M
authors.lastname: Schlumberger
authors.forename: E
authors.initials: E
authors.lastname: Vidor
authors.forename: G
authors.initials: G
authors.lastname: Soula
authors.forename: A
authors.initials: A
authors.lastname: Genet
authors.forename: S M
authors.initials: SM
authors.lastname: Standaert
authors.forename: P
authors.initials: P
authors.lastname: Saliou
mesh_terms: D000293:Adolescent; D000328:Adult; D000349:Africa; D004168:Diphtheria Toxoid / Q000008:administration & dosage / Q000276:immunology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects; D005260:Female; D005602:France; D022362:Hepatitis A Vaccines; D017957:Hepatitis A Virus, Human / Q000276:immunology; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D007277:Injections, Jet / Q000295:instrumentation* / Q000379:methods / Q000592:standards; D008297:Male; D008875:Middle Aged; D010567:Pertussis Vaccine / Q000008:administration & dosage / Q000276:immunology; D012015:Reference Standards; D013594:Syringes / Q000592:standards; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014436:Typhoid-Paratyphoid Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014612:Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D015164:Vaccines, Inactivated / Q000009:adverse effects; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D004168:Diphtheria Toxoid; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022362:Hepatitis A Vaccines; D007252:Influenza Vaccines; D010567:Pertussis Vaccine; D013745:Tetanus Toxoid; D014436:Typhoid-Paratyphoid Vaccines; D014612:Vaccines; D015164:Vaccines, Inactivated; D014761:Viral Hepatitis Vaccines