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

Abstract：

: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.

journal_name

Vaccine

journal_title

Vaccine

authors

Vescovo P,Rettby N,Ramaniraka N,Liberman J,Hart K,Cachemaille A,Piveteau LD,Zanoni R,Bart PA,Pantaleo G

doi

10.1016/j.vaccine.2016.09.069

subject

Has Abstract

pub_date

2017-03-27 00:00:00

pages

1782-1788

issue

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(16)30942-2

journal_volume

pub_type

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