Safety and immunogenicity of fractional dose intradermal injection of two quadrivalent conjugated meningococcal vaccines

Vaccine
Emile F F JonkerLeo G Visser

Abstract

Vaccination with conjugated meningococcal vaccines is the best way to prevent invasive meningococcal disease. Changes in serogroup epidemiology have led to the inclusion of quadrivalent vaccines in the national immunization programs of several countries, but vaccines are frequently in short supply. Intradermal administration has the potential to increase vaccine availability through dose reduction, without sacrificing efficacy. It has never before been investigated for glycoconjugate meningococcal vaccines. Different fractional doses of two quadrivalent meningococcal conjugate vaccines (MenACWY-CRM197 (Menveo®) and MenACWY-TT (Nimenrix®)) were administered intradermally to sequential groups of 4 participants, according to an adaptive dose escalation design, starting at 1/10th of the original dose. Booster doses were given after 4-6 months based on interim serology results using a multiplex bead-based assay (MIA). Final analyses were based on serum bactericidal antibody titers (rSBA). A total of 12 subjects were enrolled (average 25 years old, range 19-48). MenACWY-CRM197 became unavailable during the course of the study and was only evaluated for a 1/10th dose. This dose resulted in less than complete seroprotection for serogro...Continue Reading

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