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
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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