Safety, tolerability and efficacy of intradermal rabies immunization with DebioJect™
Autor: | Julie Liberman, Pierre-Alexandre Bart, Laurent-Dominique Piveteau, Paul Vescovo, Reto Zanoni, Nirinarilala Ramaniraka, Astrid Cachemaille, Giuseppe Pantaleo, Nils Rettby, Karen Hart |
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Rok vydání: | 2017 |
Předmět: |
Male
02 engineering and technology Antibodies Viral medicine.disease_cause 0302 clinical medicine Rabies vaccine Outcome Assessment Health Care 030212 general & internal medicine Intradermal injection 610 Medicine & health 630 Agriculture Vaccination Middle Aged 021001 nanoscience & nanotechnology Adolescent Adult Antibodies Neutralizing/blood Antibodies Neutralizing/immunology Antibodies Viral/blood Antibodies Viral/immunology Female Healthy Volunteers Humans Injections Intradermal Injections Intramuscular Outcome Assessment (Health Care) Rabies/prevention & control Rabies Vaccines/administration & dosage Rabies Vaccines/adverse effects Rabies Vaccines/immunology Vaccination/adverse effects Vaccination/methods Young Adult Drug delivery Microneedle Infectious Diseases Tolerability Anesthesia Molecular Medicine 0210 nano-technology medicine.drug Rabies 03 medical and health sciences Immunology and Microbiology(all) medicine Adverse effect Reactogenicity General Veterinary General Immunology and Microbiology business.industry Rabies virus Public Health Environmental and Occupational Health medicine.disease veterinary(all) Antibodies Neutralizing Rabies Vaccines Immunology 570 Life sciences biology business |
Zdroj: | Vescovo, Paul; Rettby, Nils; Ramaniraka, Nirinarilala; Liberman, Julie; Hart, Karen; Cachemaille, Astrid; Piveteau, Laurent-Dominique; Zanoni, Reto Giacomo; Bart, Pierre-Alexandre; Pantaleo, Giuseppe (2017). Safety, tolerability and efficacy of intradermal rabies immunization with DebioJect™. Vaccine, 35(14), pp. 1782-1788. Elsevier 10.1016/j.vaccine.2016.09.069 Vaccine, vol. 35, no. 14, pp. 1782-1788 |
ISSN: | 0264-410X |
Popis: | In a single-center study, 66 healthy volunteers aged between 18 and 50years were randomized to be immunized against rabies with three different injection routes: intradermal with DebioJect™ (IDJ), standard intradermal with classical needle (IDS), also called Mantoux method, and intramuscular with classical needle (IM). "Vaccin rabique Pasteur®" and saline solution (NaCl 0.9%) were administered at D0, D7 and D28. Antigen doses for both intradermal routes were 1/5 of the dose for IM. Tolerability, safety and induced immunogenicity of IDJ were compared to IDS and IM routes. Pain was evaluated at needle insertion and at product injection for all vaccination visits. Solicited Adverse Event (SolAE) and local reactogenicity symptoms including pain, redness and pruritus were recorded daily following each vaccination visit. Adverse events (AE) were recorded over the whole duration of the study. Humoral immune response was measured by assessing the rabies virus neutralizing antibody (VNA) titers using Rapid Fluorescent Focus Inhibition Test (RFFIT). Results demonstrated that the DebioJect™ is a safe, reliable and efficient device. Significant decreases of pain at needle insertion and at vaccine injection were reported with IDJ compared to IDS and IM. All local reactogenicity symptoms (pain, redness and pruritus) after injection with either vaccine or saline solution, were similar for IDJ and IDS, except that IDJ injection induced more redness 30min after saline solution. No systemic SolAE was deemed related to DebioJect™ and classical needles. No AE was deemed related to DebioJect™. No Serious Adverse Event (SAE) was reported during the study. At the end of the study all participants were considered immunized against rabies and no significant difference in humoral response was observed between the 3 studied routes. |
Databáze: | OpenAIRE |
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