Safety and immunogenicity of a meningococcal B bivalent rLP2086 vaccine in healthy toddlers aged 18-36 Months: a phase 1 randomized-controlled clinical trial

Marshall, Helen S., Richmond, Peter C., Nissen, Michael D., Jiang, Qin, Anderson, Annaliesa S., Jansen, Kathrin U., Reynolds, Graham, Ziegler, John B., Harris, Shannon L., Jones, Thomas R. and Perez, John L. (2012) Safety and immunogenicity of a meningococcal B bivalent rLP2086 vaccine in healthy toddlers aged 18-36 Months: a phase 1 randomized-controlled clinical trial. Pediatric Infectious Disease Journal, 31 10: 1061-1068. doi:10.1097/INF.0b013e31826327e4


Author Marshall, Helen S.
Richmond, Peter C.
Nissen, Michael D.
Jiang, Qin
Anderson, Annaliesa S.
Jansen, Kathrin U.
Reynolds, Graham
Ziegler, John B.
Harris, Shannon L.
Jones, Thomas R.
Perez, John L.
Total Author Count Override 11
Title Safety and immunogenicity of a meningococcal B bivalent rLP2086 vaccine in healthy toddlers aged 18-36 Months: a phase 1 randomized-controlled clinical trial
Journal name Pediatric Infectious Disease Journal   Check publisher's open access policy
ISSN 0891-3668
1532-0987
Publication date 2012-10-01
Sub-type Article (original research)
DOI 10.1097/INF.0b013e31826327e4
Volume 31
Issue 10
Start page 1061
End page 1068
Total pages 8
Place of publication Philadelphia, PA, United States
Publisher Lippincott Williams & Wilkins
Collection year 2013
Language eng
Formatted abstract
BACKGROUND:
A bivalent, recombinant, factor H-binding protein (rLP2086) vaccine was developed to protect against invasive Neisseria meningitidis serogroup B (MnB) in children and adolescents.

METHODS:
Healthy toddlers (N = 99) were enrolled to 3 ascending dose-level cohorts (20, 60 or 200 μg). Within each cohort (n = 33), subjects were randomized to receive an initial formulation of the bivalent rLP2086 vaccine at 0, 1 and 6 months or hepatitis A vaccine/placebo control (2:1 ratio). Reactogenicity was assessed by parental reporting of local and systemic reactions using electronic diaries and reports of unsolicited adverse events. Immunogenicity was assessed by serum bactericidal activity assay using human complement and rLP2086-specific IgG binding.

RESULTS:
The vaccine was considered to be well tolerated. Tenderness was the most frequently reported local reaction. Upper respiratory tract infection was the most commonly reported adverse event and occurred more frequently in the control group. Three cases (200 μg dose) of severe erythema that did not interfere with limb movement were reported. Four toddlers developed fever >40.0°C, 3 in the 200 μg group and 1 in the 60 μg group. Postdose 3, seroconversion (serum bactericidal activity assay using human complement ≥4-fold rise from baseline) was observed in 61.1-88.9% of participants against MnB strains expressing LP2086 variants homologous or nearly homologous to vaccine antigens and 11.1-44.4% against MnB strains expressing heterologous LP2086 variants. Seroconversion was observed in 77.8-100% of participants against additional, exploratory MnB strains expressing vaccine-homologous or heterologous LP2086 variants.

CONCLUSIONS:
This study shows that the bivalent rLP2086 vaccine is well tolerated and immunogenic in toddlers.
Keyword Neisseria meningitidis serogroup B
Meningococcal vaccine
Factor H-binding protein
Bactericidal antibodies
Protein-based vaccine antigens
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2013 Collection
School of Medicine Publications
 
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