Safety, tolerability and efficacy of intradermal rabies immunization with DebioJect™.

Détails

Ressource 1Télécharger: 1-s2.0-S0264410X16309422-main.pdf (739.22 [Ko])
Etat: Public
Version: Final published version
ID Serval
serval:BIB_A7C81D7FFA31
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Compte-rendu: analyse d'une oeuvre publiée.
Collection
Publications
Institution
Titre
Safety, tolerability and efficacy of intradermal rabies immunization with DebioJect™.
Périodique
Vaccine
Auteur⸱e⸱s
Vescovo P., Rettby N., Ramaniraka N., Liberman J., Hart K., Cachemaille A., Piveteau L.D., Zanoni R., Bart P.A., Pantaleo G.
ISSN
1873-2518 (Electronic)
ISSN-L
0264-410X
Statut éditorial
Publié
Date de publication
27/03/2017
Peer-reviewed
Oui
Volume
35
Numéro
14
Pages
1782-1788
Langue
anglais
Notes
Publication types: Clinical Trial, Phase I ; Journal Article
Publication Status: ppublish
Résumé
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.

Mots-clé
Adolescent, Adult, Antibodies, Neutralizing/blood, Antibodies, Neutralizing/immunology, Antibodies, Viral/blood, Antibodies, Viral/immunology, Female, Healthy Volunteers, Humans, Injections, Intradermal, Injections, Intramuscular, Male, Middle Aged, 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, Intradermal injection, Microneedle, Rabies vaccine
Pubmed
Web of science
Open Access
Oui
Création de la notice
28/03/2017 17:13
Dernière modification de la notice
20/08/2019 15:12
Données d'usage