Neisseria meningitidis group B correlates of protection and assay standardization—International Meeting Report Emory University, Atlanta, Georgia, United States, 16–17 March 2005

Borrow, Ray; Carlone, George M.; Rosenstein, Nancy E.; Blake, M. S.; Feavers, Ian M.; Martin, Diana; Zollinger, Wendell D.; Robbins, J B; Aaberge, Ingeborg S.; Granoff, Dan M.; Miller, Elizabeth; Plikaytis, Brian D.; Alphen, Loek van; Poolman, Jan; Rappuoli, Rino; Danzig, Lisa; Hackell, Jill G.; Danve, B.; Caulfield, Michael J.; Lambert, Stephen; Stephens, David S.

doi:10.1016/j.vaccine.2006.03.091

Cited by 181 publications

(128 citation statements)

References 87 publications

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“…11 Assays for hSBA against strains 44/76-SL, 5/99 and NZ98/254 were performed at the laboratory of the Health Protection Agency (Manchester, UK) and those for hSBA against strains M10713, UKP1.7-2,4, GB101, GB355 and GB364 at the Novartis Vaccine Clinical Serology Laboratory (Marburg, Germany).…”

Section: Immunogenicitymentioning

confidence: 99%

“…An hSBA titre of 1:4 or greater was used as the correlate of protection, as a postvaccination increase in antibody titre of this magnitude has been shown to correlate with clinical efficacy in previous vaccine trials involving other outer membrane vesicle vaccines. 11 Assays for hSBA against strains 44/76-SL, 5/99 and NZ98/254 were performed at the laboratory of the Health Protection Agency (Manchester, UK) and those for hSBA against strains M10713, UKP1.7-2,4, GB101, GB355 and GB364 at the Novartis Vaccine Clinical Serology Laboratory (Marburg, Germany). …”

mentioning

confidence: 99%

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Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months

McQuaid

Snape

John

et al. 2015

CMAJ

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Interpretation: Waning of immunity by 5 years of age occurred after receipt of the 4CMenB vaccine in infancy, even with an additional booster at 40 months. The 4CMenB vaccine is immunogenic and was fairly well tol erated by 5-year-old children, although injection-site pain was noteworthy. Trial registration: Clinical Trials.gov, no. NCT01027351 Abstract Research E216CMAJ, April 21, 2015, 187 (7) We present here the results of a follow-on study investigating the persistence of antibodies 18-20 months after the last dose in 5-year-old children previously immunized under a variety of schedules with 4CMenB vaccine or another investigational vaccine (recombinant protein serogroup B meningococcal [rMenB] vaccine), which lacks the outer membrane vesicle component of the 4CMenB vaccine. Since the original infant study, 7 4CMenB vaccine has emerged as the preferred vaccine, because addition of the outer membrane vesicle component improves the breadth of strain coverage; 8 however, the extension study continued follow-up for all of the original children, and all results are therefore presented here. MethodsThis phase 2, open-label, single-centre extension study ran from January 2010 to August 2012 and was approved by the Oxfordshire Research Ethics Committee B (reference 09/H0605/89).The primary immunogenicity objective of the extension study was to assess persistence of antibodies at 40 months of age, as reported previously. 9 Here, we present the secondary outcomes of antibody persistence at 60 months of age and the immunogenicity, safety and tolerability of a 2-dose catch-up regimen of 4CMenB vaccine administered at 60 and 62 months. ParticipantsIn the original infant study, 7 147 infants from the UK were recruited and randomly assigned, on a 2:2:1:1 ratio, to receive 4CMenB or rMenB vaccine at 2, 4, 6 and 12 months or to receive one of these vaccines at 12 months alone.Of these 147 infants, 70 participated in the 40-month extension study, 9 in which those who originally received 4 doses received 1 additional dose (at 40 mo) and those who originally received 1 dose received 2 additional doses (at 40 and 42 mo) of the vaccine originally received. These groups are referred to here as follows: 4CMenB 2, 4,6,12,40; rMenB 2,4,6,12,40; 4CMenB 12,40,42; and rMenB 12,40,42. A fifth group (referred to as 4CMenB 40,42) received 2 doses of 4CMenB vaccine only at 40 and 42 months. All of these children were invited to participate again at about 60 months of age, and an additional 50 healthy, vaccine-naive controls (referred to as 4CMenB 60,62) were recruited by mail. The study therefore included a total of 6 groups (see Figure 1).Exclusion criteria were as follows: any previous meningococcal vaccination or history of meningococcal disease, severe allergy to any component of the vaccine, and any serious chronic or progressive disease or suspected immune system impairment. Administration of other vaccines was not permitted within 30 days before or after meningococcal vaccination, with the exception of the influenza vaccine, which c...

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Section: Immunogenicitymentioning

confidence: 99%

mentioning

confidence: 99%

Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months

McQuaid

Snape

John

et al. 2015

CMAJ

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“…It is well established that the presence of antibodies able to kill the bacteria in the presence of human complement (bactericidal antibodies) correlates with protection from disease (2). Glycoconjugate vaccines against serogroups A, C, W-135, and Y, as well as tailor-made meningococcal serogroup B outer membrane vesicle (OMV) vaccines, have considerably decreased disease in regions where these vaccines have been used (3).…”

mentioning

confidence: 99%

Neisseria meningitidis GNA2132, a heparin-binding protein that induces protective immunity in humans

Serruto

Spadafina

Ciucchi

et al. 2010

Proc. Natl. Acad. Sci. U.S.A.

188

220

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GNA2132 is a Neisseria meningitidis antigen of unknown function, discovered by reverse vaccinology, which has been shown to induce bactericidal antibodies in animal models. Here we show that this antigen induces protective immunity in humans and it is recognized by sera of patients after meningococcal disease. The protein binds heparin in vitro through an Arg-rich region and this property correlates with increased survival of the unencapsulated bacterium in human serum. Furthermore, two proteases, the meningococcal NalP and human lactoferrin, cleave the protein upstream and downstream from the Arg-rich region, respectively. We conclude that GNA2132 is an important protective antigen of N. meningitidis and we propose to rename it, N eisserial H eparin B inding A ntigen (NHBA).

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“…11 It should be realized, that although SBA is the best correlate of protection for meningococcal vaccines, it is now generally accepted that the SBA underestimates the effectiveness of MenB vaccines. 26,27 Therefore additional methods, especially opsonic activity, need to be pursued to more fully characterize the immune response against MenB vaccines, especially the new recombinant protein vaccine candidates. However, in clinical trials only SBA has been measured as surrogate marker.…”

Section: Vaccine Evaluation: Surrogate Markers For Protection and Strmentioning

confidence: 99%

Meningococcal B vaccine development and evaluation of efficacy

Alphen¹,

Dobbelsteen²

2008

Human Vaccines

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Neisseria meningitidis group B correlates of protection and assay standardization—International Meeting Report Emory University, Atlanta, Georgia, United States, 16–17 March 2005

Cited by 181 publications

References 87 publications

Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months

Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months

Neisseria meningitidis GNA2132, a heparin-binding protein that induces protective immunity in humans

Meningococcal B vaccine development and evaluation of efficacy

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