PDF(Pubmed)
Abstract：
BACKGROUND: Many immunization programs in Europe recommend quadrivalent meningococcal vaccinations, which are often administered concomitantly with other vaccines. We compared the immune response of a tetanus toxoid conjugated quadrivalent meningococcal vaccine (MenACYW-TT, MenQuadfi®) with another quadrivalent meningococcal conjugate vaccine (MCV4-TT; Nimenrix®) when administered alone or concomitantly with Tdap-IPV and 9vHPV vaccines in adolescents.
METHODS: In this phase IIIb trial, healthy adolescents (MenC-naïve or MenC-primed before 2 years of age) from Spain, Italy, Hungary, and Singapore were randomized in a 3:3:2 ratio to receive either MenACYW-TT or MCV4-TT alone, or MenACYW-TT concomitantly with 9vHPV and Tdap-IPV. The primary objective was to demonstrate the non-inferiority of the seroprotection rate (human serum bactericidal assay [hSBA] titer ≥ 1:8) to serogroups A, C, W, and Y 30 days post-vaccination with a single dose of MenACYW-TT or MCV4-TT. Secondary objectives included describing hSBA titers for the four serogroups before and 1 month following vaccination and according to MenC priming status.
RESULTS: A total of 463 participants were enrolled (MenACYW-TT, n = 173; MCV4-TT, n = 173; MenACYW-TT/9vHPV/Tdap-IPV n = 117). Non-inferiority based on seroprotection was demonstrated for MenACYW-TT versus MCV4-TT for all serogroups. Immune responses were comparable whether MenACYW-TT was administered alone or concomitantly with Tdap-IPV and 9vHPV. Post-vaccination hSBA GMTs were higher in MenACYW-TT vs. MCV4-TT for serogroups C, Y, and W and comparable for serogroup A. The percentages of participants with an hSBA vaccine seroresponse were higher in MenACYW-TT vs. MCV4-TT for all serogroups. For serogroup C, higher GMTs were observed in both MenC-naïve or -primed participants vaccinated with MenACYW-TT vs. MCV4-TT. Seroprotection and seroresponse were higher in MenC-naïve participants vaccinated with MenACYW-TT vs. MCV4-TT and comparable in MenC-primed. The safety profiles were comparable between groups and no new safety concerns were identified.
CONCLUSIONS: These data support the concomitant administration of MenACYW-TT with 9vHPV and Tdap-IPV vaccines in adolescents.
BACKGROUND: Clinicaltrials.gov, NCT04490018; EudraCT: 2020-001665-37; WHO: U1111-1249-2973.
MenACYW conjugate vaccine has been made to protect against meningococcal disease caused by four common types of bacteria (germs) called Neisseria meningitidis (or meningococcus), A, C, W, and Y. Many people, particularly adolescents, have the germs of this disease in their nose or throat, and therefore may develop the disease or transmit the bacteria to other people. Hence, adolescent meningococcal vaccination against serogroups ACWY is increasingly recommended in several countries. This study assessed the immune response to these serogroups in healthy adolescents after one dose of MenACYW conjugate vaccine or Nimenrix®, a meningococcal licensed vaccine. Moreover, the immune response and safety were assessed when the vaccines were given alone or when given concomitantly with other adolescent vaccines, including the human papillomavirus (9vHPV) and tetanus, diphtheria, pertussis, and poliomyelitis (Tdap-IPV) vaccines. A total of 463 adolescents (aged 10–17 years) participated in this study and received either MenACYW or Nimenrix® alone, or MenACYW concomitantly with 9vHPV and Tdap-IPV vaccine. The immune response induced by MenACYW was as good as the immune response induced by Nimenrix®, and when given alone or concomitantly with 9vHPV and Tdap IPV vaccines. None of the participants experienced any serious side effects of any vaccine. The most common non-serious side effects were injection site pain, muscle pain, and headache. These data support the use of MenACYW in adolescents, with or without concomitant administration with 9vHPV and Tdap-IPV, which may help to increase the number of adolescents vaccinated.
METHODS: In this phase IIIb trial, healthy adolescents (MenC-naïve or MenC-primed before 2 years of age) from Spain, Italy, Hungary, and Singapore were randomized in a 3:3:2 ratio to receive either MenACYW-TT or MCV4-TT alone, or MenACYW-TT concomitantly with 9vHPV and Tdap-IPV. The primary objective was to demonstrate the non-inferiority of the seroprotection rate (human serum bactericidal assay [hSBA] titer ≥ 1:8) to serogroups A, C, W, and Y 30 days post-vaccination with a single dose of MenACYW-TT or MCV4-TT. Secondary objectives included describing hSBA titers for the four serogroups before and 1 month following vaccination and according to MenC priming status.
RESULTS: A total of 463 participants were enrolled (MenACYW-TT, n = 173; MCV4-TT, n = 173; MenACYW-TT/9vHPV/Tdap-IPV n = 117). Non-inferiority based on seroprotection was demonstrated for MenACYW-TT versus MCV4-TT for all serogroups. Immune responses were comparable whether MenACYW-TT was administered alone or concomitantly with Tdap-IPV and 9vHPV. Post-vaccination hSBA GMTs were higher in MenACYW-TT vs. MCV4-TT for serogroups C, Y, and W and comparable for serogroup A. The percentages of participants with an hSBA vaccine seroresponse were higher in MenACYW-TT vs. MCV4-TT for all serogroups. For serogroup C, higher GMTs were observed in both MenC-naïve or -primed participants vaccinated with MenACYW-TT vs. MCV4-TT. Seroprotection and seroresponse were higher in MenC-naïve participants vaccinated with MenACYW-TT vs. MCV4-TT and comparable in MenC-primed. The safety profiles were comparable between groups and no new safety concerns were identified.
CONCLUSIONS: These data support the concomitant administration of MenACYW-TT with 9vHPV and Tdap-IPV vaccines in adolescents.
BACKGROUND: Clinicaltrials.gov, NCT04490018; EudraCT: 2020-001665-37; WHO: U1111-1249-2973.
MenACYW conjugate vaccine has been made to protect against meningococcal disease caused by four common types of bacteria (germs) called Neisseria meningitidis (or meningococcus), A, C, W, and Y. Many people, particularly adolescents, have the germs of this disease in their nose or throat, and therefore may develop the disease or transmit the bacteria to other people. Hence, adolescent meningococcal vaccination against serogroups ACWY is increasingly recommended in several countries. This study assessed the immune response to these serogroups in healthy adolescents after one dose of MenACYW conjugate vaccine or Nimenrix®, a meningococcal licensed vaccine. Moreover, the immune response and safety were assessed when the vaccines were given alone or when given concomitantly with other adolescent vaccines, including the human papillomavirus (9vHPV) and tetanus, diphtheria, pertussis, and poliomyelitis (Tdap-IPV) vaccines. A total of 463 adolescents (aged 10–17 years) participated in this study and received either MenACYW or Nimenrix® alone, or MenACYW concomitantly with 9vHPV and Tdap-IPV vaccine. The immune response induced by MenACYW was as good as the immune response induced by Nimenrix®, and when given alone or concomitantly with 9vHPV and Tdap IPV vaccines. None of the participants experienced any serious side effects of any vaccine. The most common non-serious side effects were injection site pain, muscle pain, and headache. These data support the use of MenACYW in adolescents, with or without concomitant administration with 9vHPV and Tdap-IPV, which may help to increase the number of adolescents vaccinated.
摘要：
背景：欧洲的许多免疫计划建议接种四价脑膜炎球菌疫苗，通常与其他疫苗同时施用。我们比较了破伤风类毒素结合四价脑膜炎球菌疫苗（MenACYW-TT，MenQuadfi®）与另一种四价脑膜炎球菌结合疫苗（MCV4-TT；Nimenrix®）在青少年中单独或与Tdap-IPV和9vHPV疫苗同时施用。
方法：在本IIIb期试验中，来自西班牙的健康青少年（MenC-幼稚或MenC-在2岁之前），意大利,匈牙利,新加坡以3:3:2的比例随机接受MenACYW-TT或MCV4-TT，或MenACYW-TT同时伴有9vHPV和Tdap-IPV。主要目的是证明血清保护率（人血清杀菌测定[hSBA]滴度≥1：8）对血清群A的非劣效性，C,W,和Y接种单剂量MenACYW-TT或MCV4-TT后30天。次要目标包括描述接种前和接种后1个月以及根据MenC引发状态的四个血清群的hSBA滴度。
结果：共纳入463名参与者（MenACYW-TT，n=173；MCV4-TT，n=173；MenACYW-TT/9vHPV/Tdap-IPVn=117）。对于所有血清群，MenACYW-TT与MCV4-TT均证明了基于血清保护的非劣效性。无论是单独施用MenACYW-TT还是与Tdap-IPV和9vHPV同时施用,免疫应答都是可比较的。疫苗接种后hSBAGMT在MenACYW-TT中高于血清群C的MCV4-TT，Y,和W以及血清群A的可比性。在MenACYW-TT中，具有hSBA疫苗血清反应的参与者百分比较高。所有血清群的MCV4-TT。对于血清群C，在接种MenACYW-TT的MenC-naive或-primed参与者中观察到更高的GMT与MCV4-TT.接种MenACYW-TT疫苗的MenC-naive参与者的血清保护和血清反应较高。MCV4-TT与MenC-primed相当。各组之间的安全性具有可比性，没有发现新的安全性问题。
结论：这些数据支持在青少年中同时使用MenACYW-TT与9vHPV和Tdap-IPV疫苗。
背景：Clinicaltrials.gov，NCT04490018；EudraCT：2020-001665-37；WHO：U1111-1249-2973。
已经研制了MenACYW结合疫苗，以预防由四种常见类型的细菌（细菌）引起的脑膜炎球菌疾病，称为脑膜炎奈瑟菌（或脑膜炎球菌）。A,C,W,还有很多人,尤其是青少年，他们的鼻子或喉咙里有这种疾病的细菌，因此可能发展疾病或将细菌传播给其他人。因此，一些国家越来越多地推荐针对ACWY血清群的青少年脑膜炎球菌疫苗接种.这项研究评估了健康青少年在一剂MenACYW结合疫苗或Nimenrix®后对这些血清群的免疫反应，脑膜炎球菌许可疫苗。此外，在单独接种疫苗或与其他青少年疫苗同时接种时，对免疫反应和安全性进行了评估，包括人乳头瘤病毒（9vHPV）和破伤风，白喉,百日咳,和脊髓灰质炎（Tdap-IPV）疫苗。共有463名青少年（10-17岁）参加了这项研究，并单独接受了MenACYW或Nimenrix®。或MenACYW同时伴有9vHPV和Tdap-IPV疫苗。MenACYW诱导的免疫反应与Nimenrix®诱导的免疫反应一样好，以及单独或同时给予9vHPV和TdapIPV疫苗时。没有参与者经历过任何疫苗的严重副作用。最常见的非严重副作用是注射部位疼痛，肌肉疼痛，和头痛。这些数据支持在青少年中使用MenACYW，伴有或不伴有9vHPV和Tdap-IPV的同时给药，这可能有助于增加青少年接种疫苗的数量。
方法：在本IIIb期试验中，来自西班牙的健康青少年（MenC-幼稚或MenC-在2岁之前），意大利,匈牙利,新加坡以3:3:2的比例随机接受MenACYW-TT或MCV4-TT，或MenACYW-TT同时伴有9vHPV和Tdap-IPV。主要目的是证明血清保护率（人血清杀菌测定[hSBA]滴度≥1：8）对血清群A的非劣效性，C,W,和Y接种单剂量MenACYW-TT或MCV4-TT后30天。次要目标包括描述接种前和接种后1个月以及根据MenC引发状态的四个血清群的hSBA滴度。
结果：共纳入463名参与者（MenACYW-TT，n=173；MCV4-TT，n=173；MenACYW-TT/9vHPV/Tdap-IPVn=117）。对于所有血清群，MenACYW-TT与MCV4-TT均证明了基于血清保护的非劣效性。无论是单独施用MenACYW-TT还是与Tdap-IPV和9vHPV同时施用,免疫应答都是可比较的。疫苗接种后hSBAGMT在MenACYW-TT中高于血清群C的MCV4-TT，Y,和W以及血清群A的可比性。在MenACYW-TT中，具有hSBA疫苗血清反应的参与者百分比较高。所有血清群的MCV4-TT。对于血清群C，在接种MenACYW-TT的MenC-naive或-primed参与者中观察到更高的GMT与MCV4-TT.接种MenACYW-TT疫苗的MenC-naive参与者的血清保护和血清反应较高。MCV4-TT与MenC-primed相当。各组之间的安全性具有可比性，没有发现新的安全性问题。
结论：这些数据支持在青少年中同时使用MenACYW-TT与9vHPV和Tdap-IPV疫苗。
背景：Clinicaltrials.gov，NCT04490018；EudraCT：2020-001665-37；WHO：U1111-1249-2973。
已经研制了MenACYW结合疫苗，以预防由四种常见类型的细菌（细菌）引起的脑膜炎球菌疾病，称为脑膜炎奈瑟菌（或脑膜炎球菌）。A,C,W,还有很多人,尤其是青少年，他们的鼻子或喉咙里有这种疾病的细菌，因此可能发展疾病或将细菌传播给其他人。因此，一些国家越来越多地推荐针对ACWY血清群的青少年脑膜炎球菌疫苗接种.这项研究评估了健康青少年在一剂MenACYW结合疫苗或Nimenrix®后对这些血清群的免疫反应，脑膜炎球菌许可疫苗。此外，在单独接种疫苗或与其他青少年疫苗同时接种时，对免疫反应和安全性进行了评估，包括人乳头瘤病毒（9vHPV）和破伤风，白喉,百日咳,和脊髓灰质炎（Tdap-IPV）疫苗。共有463名青少年（10-17岁）参加了这项研究，并单独接受了MenACYW或Nimenrix®。或MenACYW同时伴有9vHPV和Tdap-IPV疫苗。MenACYW诱导的免疫反应与Nimenrix®诱导的免疫反应一样好，以及单独或同时给予9vHPV和TdapIPV疫苗时。没有参与者经历过任何疫苗的严重副作用。最常见的非严重副作用是注射部位疼痛，肌肉疼痛，和头痛。这些数据支持在青少年中使用MenACYW，伴有或不伴有9vHPV和Tdap-IPV的同时给药，这可能有助于增加青少年接种疫苗的数量。
