Safety, tolerability and efficacy of intradermal rabies immunization with DebioJect™.
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.
Debiotech SA, Lausanne, Switzerland. Electronic address: p.vescovo@debiotech.com.
Paul
P
Vescovo
Vaccine and Immunotherapy Center, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
Nils
N
Rettby
Debiotech SA, Lausanne, Switzerland.
Nirinarilala
N
Ramaniraka
Vaccine and Immunotherapy Center, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
Julie
J
Liberman
Vaccine and Immunotherapy Center, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
Karen
K
Hart
Debiotech SA, Lausanne, Switzerland.
Astrid
A
Cachemaille
Debiotech SA, Lausanne, Switzerland.
Laurent-Dominique
LD
Piveteau
Institute of Virology and Immunology in cooperation with the Vetsuisse Faculty of the University of Bern, Bern, Switzerland.
Reto
R
Zanoni
Vaccine and Immunotherapy Center, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
Pierre-Alexandre
PA
Bart
Vaccine and Immunotherapy Center, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
Giuseppe
G
Pantaleo
D000293:Adolescent; D000328:Adult; D057134:Antibodies, Neutralizing / Q000097:blood / Q000276:immunology; D000914:Antibodies, Viral / Q000097:blood / Q000276:immunology; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011818:Rabies / Q000517:prevention & control*; D011819:Rabies Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects / Q000379:methods; D055815:Young Adult
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011819:Rabies Vaccines
Drug delivery; Intradermal injection; Microneedle; Rabies vaccine