Investigation on the Effect of Immune Selection on Resistance to Bactericidal Antibodies to Group B Meningococci In Vitro

Santos, George França dos; Giuliani, Marzia M.; Santini, Laura; Adu‐Bobie, Jeannette; Pizza, Mariagrazia; Rappuoli, Rino; Wacknov, William; Donnelly, John

doi:10.1128/cvi.00125-09

Cited by 3 publications

(3 citation statements)

References 17 publications

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“…Results for MenACWY-CRM were consistent with those in previously published studies where participants were blinded to vaccine (16,19). However, somewhat more reactogenicity was reported than in previous studies of New Zealand OMV vaccine or preliminary results of trials of 4CMenB in adults presented at scientific meetings ( The small sample size and open-label design of this study also limit the applicability of these results to other situations and populations.…”

Section: Discussionsupporting

confidence: 88%

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Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM ₁₉₇ Conjugate Vaccine against Serogroups A, C, W-135, and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates

Kimura

Toneatto

Kleinschmidt

et al. 2011

Clin Vaccine Immunol

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Laboratory staff who work with meningococcal isolates are at increased risk for developing invasive disease relative to the general population. This was the first study of laboratory workers who received both a conjugate vaccine against meningococcal serogroups A, C, W-135, and Y (Men ACWY-CRM, Menveo) and an investigational multicomponent vaccine against serogroup B containing factor H binding protein, neisserial adhesin A, Neisseria heparin binding antigen, and New Zealand strain outer membrane vesicles (4CMenB). Healthy adults (18 to 50 years of age) received three doses of 4CMenB at baseline, 2 months, and 6 months followed by a single dose of MenACWY-CRM 1 month later. Immunogenicity was assessed via serum bactericidal assay using human complement (hSBA) at 1 month postvaccination; solicited reactogenicity and adverse events were monitored. Fifty-four participants enrolled. Bactericidal immune responses were evident after each dose of 4CMenB, as assessed by hSBA geometric mean titers and percentages of subjects with hSBA titers of >4 against the test strains or a 4-fold rise in titer over baseline. At 1 month postvaccination, most MenACWY-CRM recipients had hSBA titers of >8 against serogroups A, C, W-135, and Y. Few participants discontinued due to an adverse event or vaccine reaction. Rates of solicited reactions were lower after MenACWY-CRM than after 4CMenB administration. Sequential administration of 4CMenB and MenACWY-CRM provided robust evidence of an immune response against serogroups A, B, C, W-135, and Y in laboratory workers routinely exposed to meningococcal isolates.

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Section: Discussionsupporting

confidence: 88%

“…The starting dilutions in the hSBA were 1:4 for serogroups A, C, W-135, and Y and 1:2 for serogroup B strains. Methods were described previously (3,9,15,16,18,19).…”

Section: Methodsmentioning

confidence: 99%

Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM ₁₉₇ Conjugate Vaccine against Serogroups A, C, W-135, and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates

Kimura

Toneatto

Kleinschmidt

et al. 2011

Clin Vaccine Immunol

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“…We have shown that the proteins present in the MenB vaccine are expressed throughout the in vitro growth cycle. It has also recently been shown that the level of antigen expression, and sensitivity to SBA, does not change after up to 5 rounds of selection in the presence of bactericidal antibodies generated in mice against the MenB antigens [43]. Since these proteins are important for growth and survival, they are likely to be expressed in vivo during colonization and/or infection, and indeed antibodies against NadA, fHBP and GNA2132 are present children convalescing after meningococcal disease, and antibody levels tend to increase with age [24,44,45].…”

Section: Discussionmentioning

confidence: 99%

Influence of serogroup B meningococcal vaccine antigens on growth and survival of the meningococcus in vitro and in ex vivo and in vivo models of infection

Seib

Oriente

Adu‐Bobie

et al. 2010

Vaccine

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A novel vaccine against serogroup B meningococcal disease - containing a combination of protein antigens identified by reverse vaccinology: fHBP fused to GNA2091, GNA2132 fused to GNA1030, and NadA - is currently in Phase III clinical trials. In order to determine the role of these antigens in the growth, survival and fitness of the meningococcus, we generated a mutant lacking the expression of all five protein antigens (5KO), a mutant lacking the three main antigens (fHBP, GNA2132 and NadA; 3KO), as well as strains lacking the single antigens. Our results show that abrogation of expression of these antigens in Neisseria meningitidis results in reduced growth in vitro, increased sensitivity of the bacterium to stresses it may encounter in the host, as well as reduced fitness in ex vivo models of infection and in an in vivo infant rat competitive index assay. These results support a multivalent vaccine approach, which was undertaken to strengthen the protective activity of the vaccine antigens, increase the breadth of MenB strains targeted by the vaccine, and limit the potential for selection of vaccine escape mutants.

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Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials

et al. 2013

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Investigation on the Effect of Immune Selection on Resistance to Bactericidal Antibodies to Group B Meningococci In Vitro

Cited by 3 publications

References 17 publications

Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM ₁₉₇ Conjugate Vaccine against Serogroups A, C, W-135, and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates

Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM ₁₉₇ Conjugate Vaccine against Serogroups A, C, W-135, and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates

Influence of serogroup B meningococcal vaccine antigens on growth and survival of the meningococcus in vitro and in ex vivo and in vivo models of infection

Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials

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Investigation on the Effect of Immune Selection on Resistance to Bactericidal Antibodies to Group B Meningococci In Vitro

Cited by 3 publications

References 17 publications

Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM 197 Conjugate Vaccine against Serogroups A, C, W-135, and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates

Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM 197 Conjugate Vaccine against Serogroups A, C, W-135, and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates

Influence of serogroup B meningococcal vaccine antigens on growth and survival of the meningococcus in vitro and in ex vivo and in vivo models of infection

Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials

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Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM ₁₉₇ Conjugate Vaccine against Serogroups A, C, W-135, and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates

Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM ₁₉₇ Conjugate Vaccine against Serogroups A, C, W-135, and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates