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, Judith; Pina, Miriam; Pan, Judy; Jordanov, Emilia; Dhingra, Mandeep Singh

doi:10.1080/21645515.2020.1733868

Cited by 19 publications

(29 citation statements)

References 22 publications

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“…One month after a single MenACWY-TT dose among adolescents and adults aged 10-55 years, the proportions who achieved hSBA titers ≥1:8 were 94%-96% for serogroup A, 94%-99% for serogroup C, 95%-99% for serogroup W, and 97%-99% for serogroup Y (151,154). Among adults aged ≥56 years, these proportions were 89%-94%, 75%-90%, 77%-80%, and 81%-92% for serogroups A, C, W, and Y, respectively (152,153). Across these age groups, MenACWY-TT seroresponse rates were noninferior to those of the comparator meningococcal vaccines (68,151,153).…”

Section: Adolescents and Adultsmentioning

confidence: 95%

“…Among adults aged ≥56 years, these proportions were 89%-94%, 75%-90%, 77%-80%, and 81%-92% for serogroups A, C, W, and Y, respectively (152,153). Across these age groups, MenACWY-TT seroresponse rates were noninferior to those of the comparator meningococcal vaccines (68,151,153). MenACWY-TT administered simultaneously with HPV and Tdap vaccines in adolescents did not result in reduced immune responses to meningococcal serogroups or tetanus, diphtheria, or HPV antigens (151).…”

Section: Adolescents and Adultsmentioning

confidence: 99%

“…As a result, relatively limited data on MenACWY-TT safety and immunogenicity are available compared with other licensed meningococcal conjugate vaccines. MenACWY-TT has been administered to nearly 5,000 persons aged ≥2 years to date through clinical trials, with demonstrated immunogenicity in this age group and elicitation of a boost response among adolescents vaccinated with MenACWY-TT who previously received MenACWY-D or MenACWY-CRM (68,(150)(151)(152)(153)(154)(155). No clinically relevant concerns about MenACWY-TT administered simultaneously with HPV or Tdap vaccines among adolescents have been identified (151).…”

Section: Menacwy-tt (Menquadfi)mentioning

confidence: 99%

“…No clinically relevant concerns about MenACWY-TT administered simultaneously with HPV or Tdap vaccines among adolescents have been identified (151). Clinical trials have demonstrated an acceptable safety profile, with injection site pain as the most common local adverse event, and myalgia, headache, and malaise as the most commonly reported systemic adverse events across age groups (68,(150)(151)(152)(153)(154)(155). Most adverse events were mild to moderate (68,(150)(151)(152)(153)(154)(155).…”

Section: Menacwy-tt (Menquadfi)mentioning

confidence: 99%

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Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

Mbaeyi¹,

Bozio²,

Duffy³

et al. 2020

MMWR Recomm. Rep.

159

169

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This report compiles and summarizes all recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) for use of meningococcal vaccines in the United States. As a comprehensive summary and update of previously published recommendations, it replaces all previously published reports and policy notes. This report also contains new recommendations for administration of booster doses of serogroup B meningococcal (MenB) vaccine for persons at increased risk for serogroup B meningococcal disease. These guidelines will be updated as needed on the basis of availability of new data or licensure of new meningococcal vaccines. ACIP recommends routine vaccination with a quadrivalent meningococcal conjugate vaccine (MenACWY) for adolescents aged 11 or 12 years, with a booster dose at age 16 years. ACIP also recommends routine vaccination with MenACWY for persons aged ≥2 months at increased risk for meningococcal disease caused by serogroups A, C, W, or Y, including persons who have persistent complement component deficiencies; persons receiving a complement inhibitor (e.g., eculizumab [Soliris] or ravulizumab [Ultomiris]); persons who have anatomic or functional asplenia; persons with human immunodeficiency virus infection; microbiologists routinely exposed to isolates of Neisseria meningitidis; persons identified to be at increased risk because of a meningococcal disease outbreak caused by serogroups A, C, W, or Y; persons who travel to or live in areas in which meningococcal disease is hyperendemic or epidemic; unvaccinated or incompletely vaccinated first-year college students living in residence halls; and military recruits. ACIP recommends MenACWY booster doses for previously vaccinated persons who become or remain at increased risk. In addition, ACIP recommends routine use of MenB vaccine series among persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease, including persons who have persistent complement component deficiencies; persons receiving a complement inhibitor; persons who have anatomic or functional asplenia; microbiologists who are routinely exposed to isolates of N. meningitidis; and persons identified to be at increased risk because of a meningococcal disease outbreak caused by serogroup B. ACIP recommends MenB booster doses for previously vaccinated persons who become or remain at increased risk. In addition, ACIP recommends a MenB series for adolescents and young adults aged 16-23 years on the basis of shared clinical decision-making to provide short-term protection against disease caused by most strains of serogroup B N. meningitidis.

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Section: Adolescents and Adultsmentioning

confidence: 95%

Section: Adolescents and Adultsmentioning

confidence: 99%

Section: Menacwy-tt (Menquadfi)mentioning

confidence: 99%

Section: Menacwy-tt (Menquadfi)mentioning

confidence: 99%

See 2 more Smart Citations

Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

Mbaeyi¹,

Bozio²,

Duffy³

et al. 2020

MMWR Recomm. Rep.

159

169

View full text Add to dashboard Cite

show abstract

“…In an exploratory phase 2 study in adults aged 56 years or older, the proportion of participants achieving hSBA titres ≥8 for serogroups A and C was comparable to those after a licensed quadrivalent meningococcal polysaccharide vaccine ( Menomune ; Sanofi Pasteur), but higher for serogroups W and Y after receiving MenQuadfi . Proportions of participants with rSBA titres greater than or equal to eight were comparable between vaccine groups for all four serogroups [ 70 ]. A booster dose was also evaluated in a phase 3 study in adolescents and adults and induced robust immune responses four to ten years after priming with MenACWY-D or MenACWY-CRM [ 71 ].…”

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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Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older

Neveu,

Mallett Moore,

Zambrano

et al. 2023

Infect Dis Ther

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Introduction A favorable benefit-risk balance is required to support licensure of biologics, in keeping with regulatory agencies’ evolving recommendations, including the United States Food and Drugs Administration. We present a structured semi-quantitative benefit-risk analysis of MenACYW-TT, a quadrivalent meningococcal conjugate vaccine against Neisseria meningitidis serogroups, A, C, W and Y versus licensed comparators in individuals aged ≥ 12 months. Methods We used data from six MenACYW-TT clinical trials, stratified by age group, versus licensed vaccines: toddlers (12–23 months; Nimenrix ® [MCV4-TT]), children (2–9 years; Menveo ® [MCV4-CRM]), adolescents (10–17 years; MCV4-CRM or Menactra ® [MCV4-DT]), adults (18–55 years; MCV4-DT) and older adults (≥ 56 years; Menomune ® –A/C/Y/W-135 [MPSV4]). Eight benefit (seroresponse and seroprotection for A, C, W and Y) and five risk outcomes (any and grade 3 solicited injection site and systemic reactions, and serious adverse events) were measured at Day 30 after initial vaccination. Analyses were conducted by baseline vaccination status (meningococcal vaccine-naïve or vaccine-primed). Results MenACYW-TT showed favorable seroresponse and seroprotection among vaccine-naïve participants aged ≥ 2 years, against all serogroups, compared with MCV4-CRM, MCV4-DT and MPSV4. In vaccine-naïve toddlers, there was a favorable effect for serogroup C, but no difference between MenACYW-TT and MCV4-TT for serogroups A, Y and W. A favorable effect for MenACYW-TT against serogroup C was observed in all vaccine-naïve and combined vaccine-naïve and MenC conjugate vaccine-primed groups. For all risk criteria, there were no differences between MenACYW-TT and MCV4s in toddlers, children, adolescents and adults. Results for solicited injection site and systemic reactions favored MPSV4 in older adults. Conclusions The benefit-risk profile for MenACYW-TT showed favorable seroresponse and seroprotection in individuals aged ≥ 2 years and no difference in risk criteria between MenACYW-TT and MCV4s. MenACYW-TT may provide an alternative to the standard-of-care for meningococcal disease prevention in those aged ≥ 12 months. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-023-00864-4.

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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

Cited by 19 publications

References 22 publications

Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

Vaccines against Meningococcal Diseases

Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older

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