Safety and efficacy of novel dermal and epidermal microneedle delivery systems for rabies vaccination in healthy adults.

Philippe E Laurent (1) , Hervé Bourhy (2, 3) , Marc Fantino (4) , Paul Alchas (5) , John A Mikszta (6)

1 BD Medical – Pharmaceutical Systems [Le Pont de Claix, France]
2 CC-OMS - Centre Collaborateur de l'OMS pour la Rage - Dynamique des lyssavirus et adaptation à l'hôte
3 CNR - Centre National de Référence de la Rage-Dynamique des Lyssavirus et adaptation à l'hôte
4 CREABio-Rhônes-Alpes
5 BD Medical – Pharmaceutical Systems [Franklin Lakes, NJ]
6 BD Technologies

In the present pilot study, intradermal ID delivery systems with a BD microneedle from 1 to 3mm in length, and epidermal delivery (BD skin abrader) through abraded skin surface relative to standard intramuscular injection were evaluated. Circulating neutralizing antibodies were measured against the rabies virus after the Vero cells rabies vaccine was administered at D0, D7, D21 and D49. This clinical evaluation in 66 healthy volunteers shows that ID delivery using BD microneedle technology of 1/4 the IM antigen dose is safe, efficient and reliable, resulting in a protective seroconversion rate. In contrast, the epidermal delivery route did not produce an immune response against the rabies vaccine.

Mots clés: Adolescent; Adult; Antibodies; Neutralizing; Viral; Female; Humans; Injections; Intradermal; Intramuscular; Needles; Pilot Projects; Rabies; Rabies Vaccines; Skin; Vaccination; Young Adult

Domaines: Virologie

Philippe E Laurent, Hervé Bourhy, Marc Fantino, Paul Alchas, John A Mikszta. Safety and efficacy of novel dermal and epidermal microneedle delivery systems for rabies vaccination in healthy adults.. Vaccine, 2010, 28 (36), pp.5850-6. ⟨10.1016/j.vaccine.2010.06.062⟩. ⟨pasteur-01491942⟩