Persistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT)

Østergaard, Lars; Wielen, Marie Van der; Bianco, Véronique; Miller, Jacqueline M.

doi:10.1016/j.ijid.2012.10.001

Cited by 25 publications

(18 citation statements)

References 19 publications

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“…The rapid decline in hSBA titers following a single dose has been observed with other group A meningococcal conjugate vaccines (16)(17)(18)(19)(20) and is consistent with observations reported in this population for rSBA GMT and IgG GMC. However, the magnitude of hSBA response is much less, and by threshold analyses, hSBA persists in a smaller proportion of the immunized group than indicated by rSBA or IgG ELISA immunoassays (2).…”

Section: Discussionsupporting

confidence: 90%

Development and Use of a Serum Bactericidal Assay Using Pooled Human Complement To Assess Responses to a Meningococcal Group A Conjugate Vaccine in African Toddlers

Bash

Lynn

Mocca

et al. 2014

Clin. Vaccine Immunol.

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A meningococcal group A polysaccharide (PS) conjugate vaccine (PsA-TT) has been developed for African countries affected by epidemic meningitis caused by Neisseria meningitidis. Complement-mediated serum bactericidal antibody (SBA) assays are used to assess protective immune responses to meningococcal vaccination. Human complement (hC=) was used in early studies demonstrating antibody-mediated protection against disease, but it is difficult to obtain and standardize. We developed and evaluated a method for sourcing hC= and then used the SBA assay with hC= (hSBA) to measure bactericidal responses to PsA-TT vaccination in 12-to 23-month-old African children. Sera with active complement from 100 unvaccinated blood donors were tested for intrinsic bactericidal activity, SBA titer using rabbit complement (rSBA), and anti-group A PS antibody concentration. Performance criteria and pooling strategies were examined and then verified by comparisons of three independently prepared hC= lots in two laboratories. hSBA titers of clinical trial sera were then determined using this complement sourcing method. Two different functional antibody tests were necessary for screening hC=. hSBA titers determined using three independent lots of pooled hC= were within expected assay variation among lots and between laboratories. In African toddlers, PsA-TT elicited higher hSBA titers than meningococcal polysaccharide or Hib vaccines. PsA-TT immunization or PS challenge of PsA-TTprimed subjects resulted in vigorous hSBA memory responses, and titers persisted in boosted groups for over a year. Quantifying SBA using pooled hC= is feasible and showed that PsA-TT was highly immunogenic in African toddlers.

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Section: Discussionsupporting

confidence: 90%

Development and Use of a Serum Bactericidal Assay Using Pooled Human Complement To Assess Responses to a Meningococcal Group A Conjugate Vaccine in African Toddlers

Bash

Lynn

Mocca

et al. 2014

Clin. Vaccine Immunol.

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“…[36][37][38] Although the hSBA assay is the most commonly used serologic marker of protection, this assay is difficult to standardize due to the nature of the reagents used. [39][40][41] The bactericidal assay using complement derived from baby rabbit serum (rSBA) is a widely accepted alternative to the hSBA. The rSBA assay generally yields higher titers than are seen in the hSBA.…”

Section: Rapid Waning Of Serogroup a Responses After Single Or Multipmentioning

confidence: 99%

Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants

Baxter

Keshavan

Welsch

et al. 2016

Human Vaccines & Immunotherapeutics

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Persistence of bactericidal antibodies following vaccination is extremely important for protection against invasive meningococcal disease, given the epidemiology and rapid progression of meningococcal infection. We present an analysis of antibody persistence and booster response to MenACWY-CRM, in adolescents, children and infants, from 7 clinical studies. Immunogenicity was assessed using the serum bactericidal assay with both human and rabbit complement. Post-vaccination hSBA titers were high, with an age-and serogroup-specific decline in titers up to 1 y and stable levels up to 5 y The waning of hSBA titers over time was more pronounced among infants and toddlers and the greatest for serogroup A. However, rSBA titers against serogroup A were consistently higher and showed little decline over time, suggesting that protection against this serogroup may be sustained. A single booster dose of MenACWY-CRM administered at 3 to 5 y induced a robust immune response in all age groups.

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“…55 In another smaller study including 36 adolescents 15 to 19 years old, a single dose of MenACWY-TT vaccine was compared to Men-PS at 42 months following vaccination. 61 All subjects in each group had serum bactericidal activity titers 1:8 against all serogroups at 42 months post-vaccination with higher GMTs than pre-vaccination titers, except for two subjects in the Men-PS group against serogroup C.…”

Section: Antibody Persistence Studiesmentioning

confidence: 84%

“…59 In addition, in the 42-month persistence study by Ostergaard et al, no SAEs among the 50 vaccinated adolescents were reported during this period. 61 In another randomized trial by Dbaibo et al, conducted at a center in Lebanon and three centers in the Philippines, MenACWY-TT had an adequate safety profile with pain (19.4%) and headache (16.3%) being the most commonly reported AEs in recruited adults 18 to 55 years old. 58 Grade 3 AEs were rarely reported in the MenACWY-TT and Men-PS groups.…”

Section: Adolescents and Adultsmentioning

confidence: 94%

Meningococcal quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT, Nimenrix™): A review of its immunogenicity, safety, co-administration, and antibody persistence

Assaf-Casals

Dbaibo

2016

Human Vaccines & Immunotherapeutics

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Introduction: Meningococcal disease is a major cause of morbidity and mortality worldwide with reported epidemics and outbreaks in different parts of the world. Despite the availability of antimicrobial therapy, challenges remain in early recognition and prevention of disease. Several vaccines have been developed to date aiming at preventing disease spread. Discussion: MenACWY-TT (Nimenrix TM ) has been extensively studied for use in different age groups. Phase II and III randomized trials have demonstrated its immunogenicity when administered in children aged 1 year and older, adolescents and adults. It has an acceptable safety profile with minor adverse events comparable to other vaccines. Follow up studies have shown persistence of protective antibodies up to three years. MenACWY-TT was safely and effectively coadministered with different recommended vaccines. Conclusion: MenACWY-TT is a safe and immunogenic vaccine that can be used to protect against these four serogroups in individuals older than 1 year of age.

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Persistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT)

Abstract: These results indicate that seroprotection following primary vaccination with MenACWY-TT extends more than 3 years. Ongoing persistence data are required to understand the duration of protection following vaccination and to guide decisions on the need for future booster doses.

Cited by 25 publications

References 19 publications

Development and Use of a Serum Bactericidal Assay Using Pooled Human Complement To Assess Responses to a Meningococcal Group A Conjugate Vaccine in African Toddlers

Development and Use of a Serum Bactericidal Assay Using Pooled Human Complement To Assess Responses to a Meningococcal Group A Conjugate Vaccine in African Toddlers

Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants

Meningococcal quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT, Nimenrix™): A review of its immunogenicity, safety, co-administration, and antibody persistence

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