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A randomized, controlled, phase 1/2 trial of a neisseria meningitidis serogroup B bivalent rLP2086 vaccine in healthy children and adolescents

Factor H binding protein (also known as LP2086) is a conserved outer membrane neisserial lipoprotein that has emerged as a strong candidate protein antigen...

Authors:
Nissen MD, Marshall HS, Richmond PC, Jiang Q, Harris SL, Jones TR, et al.

Authors notes:
Pediatric Infectious Disease Journal. 2013;32(4):364-371

Keywords:
Adolescents, Children, Factor H binding protein, Meningococcal vaccines, Neisseria meningitidis serogroup B

Abstract:
Neisseria meningitidis serogroup B (MnB) is a significant cause of invasive meningococcal disease.

Factor H binding protein (also known as LP2086) is a conserved outer membrane neisserial lipoprotein that has emerged as a strong candidate protein antigen for MnB vaccination.

This study examined the safety, tolerability and immunogenicity of an initial formulation of a bivalent recombinant LP2086 (rLP2086) vaccine in healthy children and adolescents.

The bivalent rLP2086 vaccine was generally well-tolerated, with mostly mild to moderate local reactions.

The most common adverse events, headache and upper respiratory tract infection, occurred with similar frequency in each group.

Post-dose 3 seroconversion rates against strains expressing B02 and A05 variants were 68.8-95.3% for rLP2086 recipients and 0% for Twinrix recipients.

The bivalent rLP2086 vaccine was well-tolerated and immunogenic in healthy children and adolescents, supporting further evaluation as a broadly protective MnB vaccine.