A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults

Marshall, Helen S., Richmond, Peter C., Nissen, Michael D., Wouters, Ann, Baber, James, Jiang, Qin, Anderson, Annaliesa S., Jones, Thomas R., Harris, Shannon L., Jansen, Kathrin U. and Perez, John L. (2013) A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults. Vaccine, 31 12: 1569-1575. doi:10.1016/j.vaccine.2013.01.021


Author Marshall, Helen S.
Richmond, Peter C.
Nissen, Michael D.
Wouters, Ann
Baber, James
Jiang, Qin
Anderson, Annaliesa S.
Jones, Thomas R.
Harris, Shannon L.
Jansen, Kathrin U.
Perez, John L.
Title A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults
Journal name Vaccine   Check publisher's open access policy
ISSN 0264-410X
1873-2518
Publication date 2013-03-15
Sub-type Article (original research)
DOI 10.1016/j.vaccine.2013.01.021
Volume 31
Issue 12
Start page 1569
End page 1575
Total pages 7
Place of publication United Kingdom
Publisher Elsevier
Collection year 2014
Language eng
Formatted abstract
Background Neisseria meningitidis serogroup B (MnB) is a leading cause of bacterial meningitis and septicemia in adolescents and young adults. No currently licensed and available vaccine has been shown to provide broad protection against endemic MnB disease. A bivalent rLP2086 vaccine based on two factor H-binding proteins (fHBPs) has been developed to provide broad protection against MnB disease-causing strains.

Methods This study assessed the safety and immunogenicity of the final formulation of a bivalent rLP2086 vaccine in 60 healthy adults (18–40 years of age) receiving 120 μg doses at 0, 1, and 6 months. Safety was assessed by collecting solicited reactogenicity data and participant-reporting of adverse events. Immunogenicity was evaluated by human serum bactericidal assay (hSBA) against 5 MnB strains expressing distinct fHBP variants and fHBP-specific immunoglobulin G titre.

Results After each immunisation, local reactions such as pain at the injection site and erythema were generally mild or moderate. The most common vaccine-related adverse event was upper respiratory tract infection, which was reported by two participants. Seroprotection (hSBA titres ≥ 1:4) was achieved in 94.3% of participants against a MnB strain expressing the vaccine-homologous fHBP variant A05 and 70.0%–94.7% against MnB strains expressing the heterologous fHBP variants B02, A22, B44, and B24. Seroconversion rates (≥4-fold rise in hSBA titres) ranged from 70.0% to 94.7% across the five MnB test strains following the 3-dose vaccination regimen. Immunogenicity responses tended to increase upon subsequent vaccine doses.

Conclusions Bivalent rLP2086 is a promising vaccine candidate for broad protection against MnB disease-causing strains.

Highlights ► First study of the final formulation of a bivalent rLP2086 vaccine in young adults. ► The vaccine was well tolerated; most AEs were not unusual for a vaccine trial. ► Most participants achieved hSBA titres ≥ 1:4 against a panel of MnB target strains. ► hSBA MnB strains expressed diverse fHBP variants and suggest broad vaccine coverage. ► Data support further clinical development of the bivalent rLP2086 vaccine.
Keyword Meningococcal vaccines
Bacterial outer membrane proteins
Bactericidal antibodies
Factor H binding protein
Serum bactericidal assay
Neisseria meningitidis serogroup B
Binding-protein vaccine
Neisseria-meningitidis
Factor-H
United-States
Adolescents
Disease
Polysaccharide
Tolerability
Lipoprotein
Candidate
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
Queensland Children's Medical Research Institute Publications
School of Medicine Publications
 
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