Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older
Abstract 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-T...
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2023-09-01
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| Series: | Infectious Diseases and Therapy |
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| Online Access: | https://doi.org/10.1007/s40121-023-00864-4 |
| _version_ | 1827781049662308352 |
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| author | David Neveu Tamala Mallett Moore Betzana Zambrano Aiying Chen Marie-Laure Kürzinger Lydie Marcelon Mandeep Singh Dhingra |
| author_facet | David Neveu Tamala Mallett Moore Betzana Zambrano Aiying Chen Marie-Laure Kürzinger Lydie Marcelon Mandeep Singh Dhingra |
| author_sort | David Neveu |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-11T15:13:22Z |
| format | Article |
| id | doaj.art-182e48bf53e04180957febc0a609af70 |
| institution | Directory Open Access Journal |
| issn | 2193-8229 2193-6382 |
| language | English |
| last_indexed | 2024-03-11T15:13:22Z |
| publishDate | 2023-09-01 |
| publisher | Adis, Springer Healthcare |
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| series | Infectious Diseases and Therapy |
| spelling | doaj.art-182e48bf53e04180957febc0a609af702023-10-29T12:31:10ZengAdis, Springer HealthcareInfectious Diseases and Therapy2193-82292193-63822023-09-0112102367238610.1007/s40121-023-00864-4Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and OlderDavid Neveu0Tamala Mallett Moore1Betzana Zambrano2Aiying Chen3Marie-Laure Kürzinger4Lydie Marcelon5Mandeep Singh Dhingra6Global Pharmacovigilance, SanofiGlobal Pharmacovigilance, SanofiGlobal Clinical Development Strategy, SanofiGlobal Biostatistical Sciences, SanofiGlobal Epidemiology and Benefit-Risk Evaluation, SanofiGlobal Epidemiology and Benefit-Risk Evaluation, SanofiGlobal Clinical Development Strategy, SanofiAbstract 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.https://doi.org/10.1007/s40121-023-00864-4Benefit-risk analysisQuadrivalent meningococcal conjugate vaccineMenACYW-TTImmunogenicitySafety |
| spellingShingle | David Neveu Tamala Mallett Moore Betzana Zambrano Aiying Chen Marie-Laure Kürzinger Lydie Marcelon Mandeep Singh Dhingra Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older Infectious Diseases and Therapy Benefit-risk analysis Quadrivalent meningococcal conjugate vaccine MenACYW-TT Immunogenicity Safety |
| title | Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older |
| title_full | Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older |
| title_fullStr | Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older |
| title_full_unstemmed | Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older |
| title_short | Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older |
| title_sort | structured benefit risk assessment of a new quadrivalent meningococcal conjugate vaccine menacyw tt in individuals ages 12 months and older |
| topic | Benefit-risk analysis Quadrivalent meningococcal conjugate vaccine MenACYW-TT Immunogenicity Safety |
| url | https://doi.org/10.1007/s40121-023-00864-4 |
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