Background: An investigational vaccine against serogroup B meningococcal (MenB) disease containing 3 main recombinant proteins (factor H-binding protein, Neisserial adhesion A, and Neisserial heparin-binding antigen) has been developed. We evaluated the immunogenicity and reactogenicity of a 3-dose course of this vaccine administered alone (recombinant MenB [rMenB]) or combined with the outer membrane vesicle (OMV) component of the vaccine used in New Zealand (rMenB+OMV).
Methods: A randomized, single-blind, comparative study of 60 healthy infants enrolled at 6 to 8 months of age and immunized with rMenB or rMenB+OMV at day 0, day 60, and at age 12 months. Blood samples obtained at baseline and 1 month following the second and third doses of vaccine were analyzed for serum bactericidal antibody (SBA) using human complement (hSBA) against 7 MenB strains. The putative correlate of protection was an hSBA titer of ≥4.
Results: The per-protocol analysis included 24 of 30 participants randomized to each group. After 3 doses of rMenB+OMV, 90% or more of participants had an hSBA titer ≥4 for 5 MenB strains, with 70% of participants having an hSBA titer ≥4 for a sixth strain. rMenB alone was immunogenic for only 3 strains. Both vaccines were well tolerated.
Conclusions: Three doses of rMenB+OMV in the second half of infancy induce bactericidal antibodies against strains expressing vaccine antigens, demonstrating the potential for broader vaccine prevention of MenB disease. This vaccine is now in phase III clinical trials.
From the *Department of Paediatrics, Oxford Vaccine Group, University of Oxford, Oxford, United Kingdom; †Novartis Vaccines and Diagnostics, Siena, Italy; ‡Vaccine Evaluation Unit, Health Protection Agency, Manchester, United Kingdom; §Novartis Vaccines and Diagnostics, Amsterdam, Netherlands; and ¶Centre for Statistics in Medicine, Oxford, UK.
Accepted for publication July 14, 2010.
Ethical approval was obtained from Oxfordshire Research Ethics Committee (Reference Number OxREC C 06/Q1606/145).
Clinical Trials identifier: NCT00433914.
Address for correspondence: Matthew Snape, MBBS, MD, FRCPCH, c/o Oxford Vaccine Group, CCVTM, Churchill Hospital, Old Rd, Headington, Oxford, United Kingdom OX3 7LJ. E-mail: email@example.com.