Safety and efficacy of novel dermal and epidermal microneedle delivery systems for rabies vaccination in healthy adults.
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.
Laurent
Philippe E
PE
BD Medical - Pharmaceutical Systems, rue Aristide Bergès, Le Pont de Claix, France. philippe_laurent@europe.bd.com
Bourhy
Hervé
H
Fantino
Marc
M
Alchas
Paul
P
Mikszta
John A
JA
D000293:Adolescent; D000328:Adult; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D006801:Humans; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D009339:Needles; D010865:Pilot Projects; D011818:Rabies / Q000517:prevention & control*; D011819:Rabies Vaccines / Q000008:administration & dosage* / Q000276:immunology; D012867:Skin / Q000276:immunology; D014611:Vaccination / Q000379:methods*; D055815:Young Adult
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011819:Rabies Vaccines