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Clinical and Vaccine Immunology, August 2009, p. 1113-1120, Vol. 16, No. 8
1071-412X/09/$08.00+0     doi:10.1128/CVI.00118-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Phase I Safety and Immunogenicity Study of a Candidate Meningococcal Disease Vaccine Based on Neisseria lactamica Outer Membrane Vesicles{triangledown}

Andrew R. Gorringe,1* Stephen Taylor,1 Charlotte Brookes,1 Mary Matheson,1 Michelle Finney,1 Moyra Kerr,1 Michael Hudson,1 Jamie Findlow,2 Ray Borrow,2 Nick Andrews,3 George Kafatos,3 Cariad M. Evans,4 and Robert C. Read4

Health Protection Agency, Centre for Emergency Preparedness and Response, Salisbury SP4 0JG,1 Vaccine Evaluation Unit, Health Protection Agency North West, Manchester Royal Infirmary, Manchester M13 9WZ,2 Health Protection Agency, Centre for Infections, Colindale, London NW9 5EQ,3 School Of Medicine & Biomedical Sciences, Medical School, University of Sheffield, Sheffield S10 2RX, United Kingdom4

Received 16 March 2009/ Returned for modification 20 May 2009/ Accepted 11 June 2009

Natural immunity to meningococcal disease in young children is associated epidemiologically with carriage of commensal Neisseria species, including Neisseria lactamica. We have previously demonstrated that outer membrane vesicles (OMVs) from N. lactamica provide protection against lethal challenge in a mouse model of meningococcal septicemia. We evaluated the safety and immunogenicity of an N. lactamica OMV vaccine in a phase I placebo-controlled, double-blinded clinical trial. Ninety-seven healthy young adult male volunteers were randomized to receive three doses of either an OMV vaccine or an Alhydrogel control. Subsequently, some subjects who had received the OMV vaccine also received a fourth dose of OMV vaccine, 6 months after the third dose. Injection site reactions were more frequent in the OMV-receiving group, but all reactions were mild or moderate in intensity. The OMV vaccine was immunogenic, eliciting rises in titers of immunoglobulin G (IgG) against the vaccine OMVs, together with a significant booster response, as determined by an enzyme-linked immunosorbent assay. Additionally, the vaccine induced modest cross-reactive immunity to six diverse strains of serogroup B Neisseria meningitidis, including IgG against meningococcal OMVs, serum bactericidal antibodies, and opsonophagocytic activity. The percentages of subjects showing ≥4-fold rises in bactericidal antibody titer obtained were similar to those previously reported for the Norwegian meningococcal OMV vaccine against the same heterologous meningococcal strain panel. In conclusion, this N. lactamica OMV vaccine is safe and induces a weak but broad humoral immune response to N. meningitidis.

* Corresponding author. Mailing address: Health Protection Agency, Centre for Emergency Preparedness and Response, Porton Down, Salisbury SP4 0JG, United Kingdom. Phone: 44 1980 612267. Fax: 44 1980 611310. E-mail: andrew.gorringe{at}hpa.org.uk

{triangledown} Published ahead of print on 24 June 2009.

Clinical and Vaccine Immunology, August 2009, p. 1113-1120, Vol. 16, No. 8
1071-412X/09/$08.00+0     doi:10.1128/CVI.00118-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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