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Clinical and Vaccine Immunology, September 2007, p. 1062-1069, Vol. 14, No. 9
1071-412X/07/$08.00+0     doi:10.1128/CVI.00094-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Immunogenicity and Safety of a Combination of Two Serogroup B Meningococcal Outer Membrane Vesicle Vaccines{triangledown}

Synne Sandbu,1 Berit Feiring,1* Philipp Oster,2 Oddveig S. Helland,1 Hilde S. W. Bakke,1 Lisbeth M. Næss,1 Audun Aase,1 Ingeborg S. Aaberge,1 Anne-Cathrine Kristoffersen,1 Kjersti M. Rydland,1 Sandrine Tilman,3 Hanne Nøkleby,1 and Einar Rosenqvist1

Division of Infectious Disease Control, Norwegian Institute of Public Health, Oslo, Norway,1 Novartis Vaccines and Diagnostics S.r.l., Siena, Italy,2 Novartis Vaccines BCDM, Amsterdam, The Netherlands3

Received 26 February 2007/ Returned for modification 9 May 2007/ Accepted 2 July 2007

MenBvac and MeNZB are safe and efficacious vaccines against serogroup B meningococcal disease. MenBvac is prepared from a B:15:P1.7,16 meningococcal strain (strain 44/76), and MeNZB is prepared from a B:4:P1.7-2,4 strain (strain NZ98/254). At 6-week intervals, healthy adults received three doses of MenBvac (25 µg), MeNZB (25 µg), or the MenBvac and MeNZB (doses of 12.5 µg of each vaccine) vaccines combined, followed by a booster 1 year later. Two-thirds of the subjects who received a monovalent vaccine in the primary schedule received the other monovalent vaccine as a booster dose. The immune responses to the combined vaccine were of the same magnitude as the homologous responses to each individual vaccine observed. At 6 weeks after the third dose, 77% and 87% of the subjects in the combined vaccine group achieved serum bactericidal titers of ≥4 against strains 44/76 and NZ98/254, respectively, and 97% and 93% of the subjects achieved a fourfold or greater increase in opsonophagocytic activity against strains 44/76 and NZ98/254, respectively. For both strains, a trend of higher responses after the booster dose was observed in all groups receiving at least one dose of the respective strain-specific vaccine. Local and systemic reactions were common in all vaccine groups. Most reactions were mild or moderate in intensity, and there were no vaccine-related serious adverse events. The safety profile of the combined vaccine was not different from those of the separate monovalent vaccines. In conclusion, use of either of the single vaccines or the combination of MenBvac and MeNZB may have a considerable impact on the serogroup B meningococcal disease situation in many countries.

* Corresponding author. Mailing address: Division of Infectious Disease Control, Norwegian Institute of Public Health, P.O. Box 4404 Nydalen, NO-0403 Oslo, Norway. Phone: (47) 2204 2261. Fax: (47) 2204 2301. E-mail: Berit.Feiring{at}fhi.no

{triangledown} Published ahead of print on 18 July 2007.

Clinical and Vaccine Immunology, September 2007, p. 1062-1069, Vol. 14, No. 9
1071-412X/07/$08.00+0     doi:10.1128/CVI.00094-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



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