Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in healthy toddlers: a Phase II randomized study

Vesikari, Timo; Borrow, Ray; Forstén, Aino; Findlow, Helen; Dhingra, Mandeep Singh; Jordanov, Emilia

doi:10.1080/21645515.2020.1733869

Cited by 23 publications

(34 citation statements)

References 22 publications

(35 reference statements)

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“…This study did not assess the levels of anti-carrier antibodies, tetanus in the case of MenACYW-TT, however, a phase II study of MenACYW-TT has shown an increase in anti-tetanus antibody levels following vaccination. 21 This study offers key data about the safety and immunogenicity profile of the MenACYW-TT conjugate vaccine when administered as a booster in an MCV4-primed population. The data strongly support MenACYW-TT conjugate vaccine as an effective booster vaccination, regardless of the type of MCV4 administered for priming.…”

Section: Discussionmentioning

confidence: 99%

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Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study

Áñez

Hedrick

Simon

et al. 2020

Human Vaccines & Immunotherapeutics

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The quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) was assessed as a booster in this Phase III trial (NCT02752906). Quadrivalent meningococcal conjugate vaccine (MCV4)primed individuals aged ≥15 y (n = 810) were randomized 1:1 to receive a single booster dose of MenACYW-TT (n = 403) or a licensed MCV4 (Menactra®; MCV4-DT [n = 407]). Serum bactericidal antibody assay with human complement (hSBA) was used to measure functional antibodies against serogroups A, C, W, and Y at baseline and Day 30 post-vaccination. Proportions of participants achieving seroresponse (post-vaccination titer ≥1:16 for those with baseline titer <1:8 or ≥4-fold increase in post-vaccination titer for those with baseline titer ≥1:8) were determined. Safety data were collected for 180 d postvaccination. Non-inferiority of the immune response was demonstrated for MenACYW-TT compared with MCV4-DT based on the proportion of participants achieving hSBA vaccine seroresponse for each of the meningococcal serogroups at Day 30. Moreover, ≥99% of participants in both study groups had hSBA titers ≥1:8 for the four meningococcal serogroups at Day 30. Reactogenicity profiles were comparable between groups. These Phase III data in adolescents and adults show that MenACYW-TT boosts the immune response in those primed with MCV4 vaccines 4-10 y previously, irrespective of whether MCV4-DT or MCV4-CRM was used for priming. ARTICLE HISTORY

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study

Áñez

Hedrick

Simon

et al. 2020

Human Vaccines & Immunotherapeutics

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“…It was licensed based on non-inferiority of immune responses as compared with those elicited by the other U.S.-licensed quadrivalent meningococcal vaccines according to the age group [ 67 ]. In a recent exploratory phase 2 study, the immunogenicity and safety of MenQuadfi was reported to be comparable with the licensed MenACWY-TT in toddlers aged 12–24 months old, although responses to serogroups A and C differed between the vaccines [ 68 ]. Non-inferiority in terms of seroresponse rates at day 30 was demonstrated versus MenACWY-CRM in a phase 2 study in adolescents between 10 and 17 years of age [ 69 ].…”

Section: Meningococcal Polysaccharide-conjugate Vaccinesmentioning

confidence: 99%

Vaccines against Meningococcal Diseases

Pizza¹,

Bekkat-Berkani

Rappuoli³

2020

Microorganisms

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Neisseria meningitidis is the main cause of meningitis and sepsis, potentially life-threatening conditions. Thanks to advancements in vaccine development, vaccines are now available for five out of six meningococcal disease-causing serogroups (A, B, C, W, and Y). Vaccination programs with monovalent meningococcal serogroup C (MenC) conjugate vaccines in Europe have successfully decreased MenC disease and carriage. The use of a monovalent MenA conjugate vaccine in the African meningitis belt has led to a near elimination of MenA disease. Due to the emergence of non-vaccine serogroups, recommendations have gradually shifted, in many countries, from monovalent conjugate vaccines to quadrivalent MenACWY conjugate vaccines to provide broader protection. Recent real-world effectiveness of broad-coverage, protein-based MenB vaccines has been reassuring. Vaccines are also used to control meningococcal outbreaks. Despite major improvements, meningococcal disease remains a global public health concern. Further research into changing epidemiology is needed. Ongoing efforts are being made to develop next-generation, pentavalent vaccines including a MenACWYX conjugate vaccine and a MenACWY conjugate vaccine combined with MenB, which are expected to contribute to the global control of meningitis.

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“…This study also did not assess the levels of anti-tetanus antibodies following vaccination with MenACYW-TT; however, a phase II study of MenACYW-TT has shown an increase in anti-tetanus antibody levels following vaccination. 26 MenACYW-TT was well tolerated and immunogenic when administered to adults aged ≥56 y. If the promising data from this exploratory study are confirmed in the Phase III trial, the MenACYW-TT has the potential to be a globally available alternative for the prevention of IMD in adults aged ≥56 y in countries (including the US) where there are no conjugate vaccines licensed in this age strata.…”

Section: Discussionmentioning

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study

Kirstein

Pina

Pan

et al. 2020

Human Vaccines & Immunotherapeutics

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MenACYW-TT is an investigational quadrivalent meningococcal conjugate vaccine intended for the prevention of invasive meningococcal disease (IMD) caused by serogroups A, C, W, and Y in individuals aged 6 weeks and above. This Phase II, randomized, open-label, multicenter, exploratory study assessed the safety and immunogenicity of MenACYW-TT compared with a quadrivalent meningococcal polysaccharide vaccine (MPSV4) in 301 healthy adults aged ≥56 y in the US (NCT01732627). Participants were randomized 2:1 to receive MenACYW-TT or MPSV4. Serum bactericidal assays using human (hSBA) or baby rabbit (rSBA) complement were used to measure functional antibodies against meningococcal serogroups A, C, W, and Y at baseline and 30 d post-vaccination. Safety data were collected up to 30 d post-vaccination. Proportions of study participants with hSBA titers ≥1:8 against serogroups A, C, W, and Y were increased at Day 30 compared with baseline in both vaccine groups. The proportions of participants with hSBA titers ≥1:8 after MenACYW-TT vaccination were comparable to those after MPSV4 vaccination for serogroups A and C (A: 93.8% vs. 85.1%; C: 74.9% vs. 62.8%) and distinctly higher than after MPSV4 for serogroups W and Y (W: 79.5% vs. 60.6%; Y: 80.5% vs. 59.6%). Proportions of participants with rSBA titers ≥1:8 were comparable between vaccine groups for all four serogroups. The reactogenicity profiles of both vaccines were similar. Most unsolicited adverse events (AEs) were of Grade 1 or Grade 2 intensity, and no serious AEs were reported. The MenACYW-TT conjugate vaccine was well tolerated and immunogenic in adults aged ≥56 y. ARTICLE HISTORY

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Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in healthy toddlers: a Phase II randomized study

Cited by 23 publications

References 22 publications

Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study

Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study

Vaccines against Meningococcal Diseases

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study

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