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Clinical and Vaccine Immunology, January 2007, p. 65-73, Vol. 14, No. 1
1071-412X/07/$08.00+0     doi:10.1128/CVI.00230-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Immunogenicity and Safety of Three Doses of a Bivalent (B:4:P1.19,15 and B:4:P1.7-2,4) Meningococcal Outer Membrane Vesicle Vaccine in Healthy Adolescents{triangledown}

Dominique Boutriau,1* Jan Poolman,1 Ray Borrow,2 Jamie Findlow,2 Javier Diez Domingo,3,4 Joan Puig-Barbera,5 José María Baldó,4,6 Victoria Planelles,4,7 Angels Jubert,4,8 Julia Colomer,4,9 Angel Gil,10 Karin Levie,11 Anne-Diane Kervyn,11 Vincent Weynants,1 Francisco Dominguez,12 Ramon Barberá,12 and Franklin Sotolongo12

GlaxoSmithKline Biologicals, Rixensart, Belgium,1 Meningococcal Reference Unit, Health Protection Agency, Manchester, United Kingdom,2 Centro de Salud Nazaret, Valencia, Spain,3 Vaccines Institute of Valencia, Valencia, Spain,4 Grupo de Investigación de Atención Primaria de Castellón, Centro de Salud Pública, Castellón, Spain,5 Centro de Salud Quart de Poblet, Valencia, Spain,6 Centro de Salud Paiporta, Valencia, Spain,7 Centro de Salud Malvarosa, Valencia, Spain,8 Centro de Salud Fuente de San Luis, Valencia, Spain,9 Universidad Rey Juan Carlos, Madrid, Spain,10 Ecole de Santé Publique, Brussels, Belgium,11 Finlay Institute, la Habana, Cuba,12

Received 22 June 2006/ Returned for modification 26 July 2006/ Accepted 13 October 2006

An experimental bivalent meningococcal outer membrane vesicle (OMV) vaccine (B:4:P1.19,15 and B:4:P1.7-2,4) has been developed to provide wide vaccine coverage particularly of the circulating strains in Europe. A randomized, controlled phase II study (study identification number, 710158/002; ClinicalTrials.gov identifier number, NCT00137917) to evaluate the immunogenicity and safety of three doses of the OMV vaccine when given to healthy 12- to 18-year-olds on a 0-2-4 month (n = 162) or 0-1-6 month schedule (n = 159). A control group received two doses of hepatitis A and one of conjugated meningococcal serogroup C vaccine on a 0-1-6 month schedule (n = 157). Immune response, defined as a fourfold increase in serum bactericidal titer using a range of vaccine-homologous or PorA-related and heterologous strains, was determined for samples taken before and 1 month after vaccination; assays were performed at two laboratories. As measured at the GlaxoSmithKline (GSK) laboratory, the OMV vaccine induced an immune response against homologous or PorA-related strains (in at least 51% of subjects against strains of serosubtype P1.19,15 and at least 66% against strains of serosubtype P1.7-2,4) and against a set of three heterologous strains (in 28% to 46% of subjects). Both laboratories showed consistent results for immune response rates. The OMV vaccine had a similar reactogenicity profile for each schedule. Pain preventing normal activities occurred in approximately one-fifth of the subjects; this was significantly higher than in the control group. The immune responses induced by the bivalent OMV vaccine demonstrated the induction of bactericidal antibodies against the vaccine-homologous/PorA-related strains but also against heterologous strains, indicating the presence of protective antigens in OMVs and confirming the potential of clinical cross-protection.

* Corresponding author. Mailing address: GlaxoSmithKline Biologicals, rue de l'Institut 89, 1330 Rixensart, Belgium. Phone: 32 2 656 91 20. Fax: 32 2 656 80 44. E-mail: dominique.boutriau{at}gskbio.com.

{triangledown} Published ahead of print on 25 October 2006.

Clinical and Vaccine Immunology, January 2007, p. 65-73, Vol. 14, No. 1
1071-412X/07/$08.00+0     doi:10.1128/CVI.00230-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



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