A Randomized, Controlled, Phase 1/2 Trial of a Neisseria meningitidis Serogroup B Bivalent rLP2086 Vaccine in Healthy Children and Adolescents

Nissen, Michael D., Marshall, Helen S., Richmond, Peter C., Jiang, Qin, Harris, Shannon L., Jones, Thomas R., Jansen, Kathrin U. and Perez, John L. (2013) A Randomized, Controlled, Phase 1/2 Trial of a Neisseria meningitidis Serogroup B Bivalent rLP2086 Vaccine in Healthy Children and Adolescents. Pediatric Infectious Disease Journal, 32 4: 364-371. doi:10.1097/INF.0b013e31827b0d24


Author Nissen, Michael D.
Marshall, Helen S.
Richmond, Peter C.
Jiang, Qin
Harris, Shannon L.
Jones, Thomas R.
Jansen, Kathrin U.
Perez, John L.
Title A Randomized, Controlled, Phase 1/2 Trial of a Neisseria meningitidis Serogroup B Bivalent rLP2086 Vaccine in Healthy Children and Adolescents
Journal name Pediatric Infectious Disease Journal   Check publisher's open access policy
ISSN 0891-3668
Publication date 2013-04
Year available 2013
Sub-type Article (original research)
DOI 10.1097/INF.0b013e31827b0d24
Volume 32
Issue 4
Start page 364
End page 371
Total pages 8
Place of publication Philadelphia, PA, United States
Publisher Lippincott Williams & Wilkins
Collection year 2014
Language eng
Abstract Background: 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. Methods: In this randomized, observer-blinded, parallel-group, multicenter trial conducted at 6 centers in Australia, 127 healthy participants aged 8–14 years were assigned to receive 20, 60 or 200 μg of the bivalent rLP2086 vaccine (n = 16, 45 and 45, respectively) or active control (Twinrix, n = 21) at 0, 1 and 6 months. Immunogenicity was assessed before the first dose and 1 month after doses 2 and 3. Local reactions, systemic events and other adverse events were recorded. The primary immunogenicity endpoint was the rate of seroconversion (≥4-fold rise in human complement serum bactericidal assay titer) against MnB strains expressing the homologous A05 or heterologous B02 LP2086 variants. Results: 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. Conclusions: The bivalent rLP2086 vaccine was well-tolerated and immunogenic in healthy children and adolescents, supporting further evaluation as a broadly protective MnB vaccine.
Formatted abstract
Background: 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.
Methods: In this randomized, observer-blinded, parallel-group, multicenter
trial conducted at 6 centers in Australia, 127 healthy participants aged 8–14
years were assigned to receive 20, 60 or 200 μg of the bivalent rLP2086
vaccine (n = 16, 45 and 45, respectively) or active control (Twinrix, n = 21)
at 0, 1 and 6 months. Immunogenicity was assessed before the first dose
and 1 month after doses 2 and 3. Local reactions, systemic events and other
adverse events were recorded. The primary immunogenicity endpoint was
the rate of seroconversion (≥4-fold rise in human complement serum bactericidal
assay titer) against MnB strains expressing the homologous A05 or
heterologous B02 LP2086 variants.
Results: 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.
Conclusions: The bivalent rLP2086 vaccine was well-tolerated and immunogenic
in healthy children and adolescents, supporting further evaluation
as a broadly protective MnB vaccine.
Keyword Meningococcal vaccines
Neisseria meningitidis serogroup B
Factor H binding protein
Children
Adolescents
Binding-Protein Vaccine
Meningococcal Disease
Factor-H
United-States
Immunogenicity
Polysaccharide
Lipoprotein
Carriage
Pathogenesis
Metaanalysis
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

 
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