Prasad S Kulkarni, Anand Kawade, Sunil Kohli, Renuka Munshi, Chetna Maliye, Nithya J Gogtay, Ravish H S, Kiranjit Singh, K Vengadakrishnan, Sandeep Kumar Panigrahi, Jyotiranjan Sahoo, Ashish Bavdekar, B S Garg, Abhishek Raut, Jeffrey P Raj, Unnati Saxena, Vijaya L Chaudhari, Rakesh Patil, Epari Venkatarao, Nitu Kumari, Dhananjay Kapse
{"title":"印度成人接种五价脑膜炎球菌结合疫苗与四价脑膜炎球菌结合疫苗的安全性和免疫原性:一项观察盲、随机、主动控制的 2/3 期研究","authors":"Prasad S Kulkarni, Anand Kawade, Sunil Kohli, Renuka Munshi, Chetna Maliye, Nithya J Gogtay, Ravish H S, Kiranjit Singh, K Vengadakrishnan, Sandeep Kumar Panigrahi, Jyotiranjan Sahoo, Ashish Bavdekar, B S Garg, Abhishek Raut, Jeffrey P Raj, Unnati Saxena, Vijaya L Chaudhari, Rakesh Patil, Epari Venkatarao, Nitu Kumari, Dhananjay Kapse","doi":"10.1016/s1473-3099(24)00576-0","DOIUrl":null,"url":null,"abstract":"<h3>Background</h3>Meningococcal disease remains an important public health problem globally. We assessed the non-inferiority and the lot-to-lot consistency of a pentavalent meningococcal ACYWX conjugate vaccine (NmCV-5; Serum Institute of India, Pune, India) versus a quadrivalent meningococcal ACWY conjugate vaccine (MenACWY-D) in healthy adults.<h3>Methods</h3>In this observer-blind, randomised, active-controlled, phase 2/3 study, healthy adults aged 18–85 years were recruited from nine hospitals across seven cities in India. Participants were grouped by age (age 18–29, 30–60, and 61–85 years), and within each age group they were randomly assigned (3:1) to receive either NmCV-5 or MenACWY-D (Sanofi Pasteur). In the age 18–29 years group, participants were additionally randomly assigned (1:1:1:1) to either lot A, lot B, or lot C of NmCV-5 or MenACWY-D. Block randomisation was used (block sizes of 4, 8, and 12). Study participants and study personnel were masked to treatment assignment. Participants received either a 0·5 mL dose of NmCV-5, containing 5 μg each of conjugated A, C, W, Y, and X polysaccharides, or 0·5 mL MenACWY-D, containing 4 μg of each of conjugated A, C, W, and Y polysaccharides. Vaccinations were administered intramuscularly in the deltoid muscle. The primary outcomes were seroresponse (non-inferiority margin of –10%) and geometric mean titres (GMTs; non-inferiority margin of 0·5) in all participants, and lot-to-lot consistency of NmCV-5 (in participants aged 18–29 years; consistency was shown if the geometric mean ratio [GMR] 95% CIs were within the limit interval of 0·5 to 2). For non-inferiority, serogroup X immune response in the NmCV-5 group was compared with the lowest immune response among serogroups A, C, W, and Y in the MenACWY-D group. Immunogenicity was assessed with a serum bactericidal activity assay that used baby rabbit serum as the complement (rSBA) on days 1 and 29 in the modified per-protocol population (including all participants who were randomly assigned, received vaccine, had a post-vaccination rSBA measurement up to 121 days after vaccination, and no major protocol violations). Solicited events were collected for 7 days and serious adverse events were collected for 180 days, and assessed in the safety population (all participants who received vaccination). This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT04358731</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, and CTRI, CTRI/2019/12/022436, and is now complete.<h3>Findings</h3>Between Dec 27, 2019, and Sept 19, 2020, 1712 individuals were screened, of whom 1640 were randomly assigned and received NmCV-5 (n=1233) or MenACWY-D (n=407; mean age 26·4 years [SD 12·2], 551 [33·6%] of 1640 were female, and 1089 [66·4%] were male). 1441 participants were aged 18–29 years (362 received lot A, 360 received lot B, and 361 received lot C of NmCV-5 and 357 received MenACWY-D, with one participant mis-randomised by age group and excluded from lot-to-lot consistency analysis). Non-inferiority of NmCV-5 against MenACWY-D was met in terms of seroresponse rates and GMT ratios for all five serogroups. The seroresponse rates were 84·3% (97·5% CI 81·7 to 86·7; serogroup A) or higher in the NmCV-5 group and 54·5% (48·5 to 60·3; serogroup A) or higher in the MenACWY-D group, with the difference in the seroresponse rate between vaccine groups ranging from 0·2 (97·5% CI –2·2 to 2·6) for serogroup W to 29·8 (24·4 to 35·2) for serogroup A. GMTs on day 29 were 7016·9 (97·5% CI 6475·7 to 7603·4; serogroup Y) or higher in the NmCV-5 group and 3646·8 (3188·2 to 4171·5; serogroup Y) or higher in the MenACWY-D group, with GMT ratios between vaccine groups for serogroups A, C, Y, and W ranging from 1·9 (97·5% CI 1·5–2·3) for serogroup W to 2·5 (2·2–2·8) for serogroup A. NmCV-5 induced robust immune responses against serogroup X. Lot-to-lot consistency of NmCV-5 was found for all five serogroups, with 95% CIs for the GMT ratio for each pair of lots being between 0·5 and 2: the lowest lower bound and the highest upper bound of the 95% CI for the GMR between NmCV-5 lot A and lot B were 0·6 and 1·4, between lot A and lot C were 0·7 and 1·6, and between lot B and lot C were 0·8 and 1·6, respectively, for any of the five serogroups. At least one solicited adverse event was reported by 527 (42·7%) of 1233 participants in the NmCV-5 group and 142 (34·9%) of 407 in the MenACWY-D group. No serious adverse events occurred that were determined to be causally related to vaccination.<h3>Interpretation</h3>NmCV-5 was non-inferior to MenACWY-D in terms of seroresponse and GMTs, was safe, and demonstrated lot-to-lot consistency. NmCV-5 is prequalified by WHO and was rolled out in the African meningitis belt in April, 2024.<h3>Funding</h3>Serum Institute of India.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4000,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study\",\"authors\":\"Prasad S Kulkarni, Anand Kawade, Sunil Kohli, Renuka Munshi, Chetna Maliye, Nithya J Gogtay, Ravish H S, Kiranjit Singh, K Vengadakrishnan, Sandeep Kumar Panigrahi, Jyotiranjan Sahoo, Ashish Bavdekar, B S Garg, Abhishek Raut, Jeffrey P Raj, Unnati Saxena, Vijaya L Chaudhari, Rakesh Patil, Epari Venkatarao, Nitu Kumari, Dhananjay Kapse\",\"doi\":\"10.1016/s1473-3099(24)00576-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3>Background</h3>Meningococcal disease remains an important public health problem globally. We assessed the non-inferiority and the lot-to-lot consistency of a pentavalent meningococcal ACYWX conjugate vaccine (NmCV-5; Serum Institute of India, Pune, India) versus a quadrivalent meningococcal ACWY conjugate vaccine (MenACWY-D) in healthy adults.<h3>Methods</h3>In this observer-blind, randomised, active-controlled, phase 2/3 study, healthy adults aged 18–85 years were recruited from nine hospitals across seven cities in India. Participants were grouped by age (age 18–29, 30–60, and 61–85 years), and within each age group they were randomly assigned (3:1) to receive either NmCV-5 or MenACWY-D (Sanofi Pasteur). In the age 18–29 years group, participants were additionally randomly assigned (1:1:1:1) to either lot A, lot B, or lot C of NmCV-5 or MenACWY-D. Block randomisation was used (block sizes of 4, 8, and 12). Study participants and study personnel were masked to treatment assignment. Participants received either a 0·5 mL dose of NmCV-5, containing 5 μg each of conjugated A, C, W, Y, and X polysaccharides, or 0·5 mL MenACWY-D, containing 4 μg of each of conjugated A, C, W, and Y polysaccharides. Vaccinations were administered intramuscularly in the deltoid muscle. The primary outcomes were seroresponse (non-inferiority margin of –10%) and geometric mean titres (GMTs; non-inferiority margin of 0·5) in all participants, and lot-to-lot consistency of NmCV-5 (in participants aged 18–29 years; consistency was shown if the geometric mean ratio [GMR] 95% CIs were within the limit interval of 0·5 to 2). For non-inferiority, serogroup X immune response in the NmCV-5 group was compared with the lowest immune response among serogroups A, C, W, and Y in the MenACWY-D group. Immunogenicity was assessed with a serum bactericidal activity assay that used baby rabbit serum as the complement (rSBA) on days 1 and 29 in the modified per-protocol population (including all participants who were randomly assigned, received vaccine, had a post-vaccination rSBA measurement up to 121 days after vaccination, and no major protocol violations). Solicited events were collected for 7 days and serious adverse events were collected for 180 days, and assessed in the safety population (all participants who received vaccination). This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\\\"Opens in new window\\\" focusable=\\\"false\\\" height=\\\"20\\\" viewbox=\\\"0 0 8 8\\\"><path d=\\\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\\\"></path></svg></span>, <span><span>NCT04358731</span><svg aria-label=\\\"Opens in new window\\\" focusable=\\\"false\\\" height=\\\"20\\\" viewbox=\\\"0 0 8 8\\\"><path d=\\\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\\\"></path></svg></span>, and CTRI, CTRI/2019/12/022436, and is now complete.<h3>Findings</h3>Between Dec 27, 2019, and Sept 19, 2020, 1712 individuals were screened, of whom 1640 were randomly assigned and received NmCV-5 (n=1233) or MenACWY-D (n=407; mean age 26·4 years [SD 12·2], 551 [33·6%] of 1640 were female, and 1089 [66·4%] were male). 1441 participants were aged 18–29 years (362 received lot A, 360 received lot B, and 361 received lot C of NmCV-5 and 357 received MenACWY-D, with one participant mis-randomised by age group and excluded from lot-to-lot consistency analysis). Non-inferiority of NmCV-5 against MenACWY-D was met in terms of seroresponse rates and GMT ratios for all five serogroups. The seroresponse rates were 84·3% (97·5% CI 81·7 to 86·7; serogroup A) or higher in the NmCV-5 group and 54·5% (48·5 to 60·3; serogroup A) or higher in the MenACWY-D group, with the difference in the seroresponse rate between vaccine groups ranging from 0·2 (97·5% CI –2·2 to 2·6) for serogroup W to 29·8 (24·4 to 35·2) for serogroup A. GMTs on day 29 were 7016·9 (97·5% CI 6475·7 to 7603·4; serogroup Y) or higher in the NmCV-5 group and 3646·8 (3188·2 to 4171·5; serogroup Y) or higher in the MenACWY-D group, with GMT ratios between vaccine groups for serogroups A, C, Y, and W ranging from 1·9 (97·5% CI 1·5–2·3) for serogroup W to 2·5 (2·2–2·8) for serogroup A. NmCV-5 induced robust immune responses against serogroup X. 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引用次数: 0
摘要
背景脑膜炎球菌疾病仍然是全球重要的公共卫生问题。我们评估了五价脑膜炎球菌 ACYWX 结合疫苗(NmCV-5;印度普纳血清研究所)与四价脑膜炎球菌 ACWY 结合疫苗(MenACWY-D)在健康成人中的非劣效性和批间一致性。方法在这项观察盲、随机、主动对照的 2/3 期研究中,我们从印度 7 个城市的 9 家医院招募了 18-85 岁的健康成人。参与者按年龄分组(18-29 岁、30-60 岁和 61-85 岁),并在每个年龄组内按 3:1 随机分配接受 NmCV-5 或 MenACWY-D (赛诺菲巴斯德)治疗。在 18-29 岁组中,参与者还被随机分配(1:1:1:1:1)到 NmCV-5 或 MenACWY-D 的 A 批、B 批或 C 批。采用区组随机分配法(区组大小为 4、8 和 12)。研究参与者和研究人员对治疗分配进行了蒙蔽。参与者接种 0-5 mL NmCV-5(含 A、C、W、Y 和 X 共轭多糖各 5 μg)或 0-5 mL MenACWY-D(含 A、C、W 和 Y 共轭多糖各 4 μg)。接种方法为三角肌肌肉注射。主要结果是所有参与者的血清反应(非劣效差为-10%)和几何平均滴度(GMT;非劣效差为0-5),以及NmCV-5的批次间一致性(18-29岁的参与者;如果几何平均比值[GMR] 95% CI在0-5至2的极限区间内,则表示一致性)。对于非劣效性,NmCV-5 组的 X 血清群免疫反应与 MenACWY-D 组的 A、C、W 和 Y 血清群中最低的免疫反应进行了比较。在修改后的按协议接种人群(包括所有随机分配、接种疫苗、接种后 rSBA 测定达 121 天且无重大违反协议行为的参与者)中,使用兔宝宝血清作为补体(rSBA),在第 1 天和第 29 天进行血清杀菌活性测定,评估免疫原性。在安全人群(所有接种疫苗的参与者)中收集 7 天的诱发事件和 180 天的严重不良事件。本研究已在ClinicalTrials.gov(NCT04358731)和CTRI(CTRI/2019/12/022436)注册,现已完成。研究结果在2019年12月27日至2020年9月19日期间,共筛选出1712人,其中1640人被随机分配并接受NmCV-5(n=1233)或MenACWY-D(n=407;平均年龄26-4岁[SD 12-2],1640人中551人[33-6%]为女性,1089人[66-4%]为男性)。1441名参与者年龄在18-29岁之间(362人接受了A批、360人接受了B批和361人接受了C批NmCV-5,357人接受了MenACWY-D,其中一名参与者因年龄组随机错误而被排除在批间一致性分析之外)。就所有五个血清群的血清反应率和 GMT 比值而言,NmCV-5 与 MenACWY-D 相比无劣效性。NmCV-5组的血清反应率为84-3%(97-5% CI为81-7至86-7;血清群A)或更高,而MenACWY-D组的血清反应率为54-5%(48-5至60-3;血清群A)或更高,疫苗组间的血清反应率差异从血清群W的0-2(97-5% CI为-2-2至2-6)到血清群A的29-8(24-4至35-2)不等。第 29 天,NmCV-5 组的 GMT 为 7016-9 (97-5% CI 6475-7 to 7603-4; Y 血清群) 或更高,MenACWY-D 组的 GMT 为 3646-8 (3188-2 to 4171-5; Y 血清群) 或更高,疫苗组间血清群 A、C、Y 和 W 的 GMT 比值从血清群 W 的 1-9 (97-5% CI 1-5-2-3) 到血清群 A 的 2-5 (2-2-2-8)不等。NmCV-5 可诱导针对血清 X 群的强大免疫反应。在所有五个血清群中,NmCV-5 的批次间一致性被发现,每对批次的 GMT 比值的 95% CI 在 0-5 和 2 之间:在五个血清群中,NmCV-5 的批次 A 和批次 B 之间 GMR 的最低下限和最高上限分别为 0-6 和 1-4,批次 A 和批次 C 之间分别为 0-7 和 1-6,批次 B 和批次 C 之间分别为 0-8 和 1-6。在 NmCV-5 组的 1233 名参与者中,有 527 人(42-7%)报告了至少一种征集到的不良事件;在 MenACWY-D 组的 407 名参与者中,有 142 人(34-9%)报告了至少一种征集到的不良事件。在血清反应和GMT方面,NmCV-5并不劣于MenACWY-D,而且安全,并表现出批次间的一致性。NmCV-5已通过世卫组织的预认证,并于2024年4月在非洲脑膜炎带推出。
Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study
Background
Meningococcal disease remains an important public health problem globally. We assessed the non-inferiority and the lot-to-lot consistency of a pentavalent meningococcal ACYWX conjugate vaccine (NmCV-5; Serum Institute of India, Pune, India) versus a quadrivalent meningococcal ACWY conjugate vaccine (MenACWY-D) in healthy adults.
Methods
In this observer-blind, randomised, active-controlled, phase 2/3 study, healthy adults aged 18–85 years were recruited from nine hospitals across seven cities in India. Participants were grouped by age (age 18–29, 30–60, and 61–85 years), and within each age group they were randomly assigned (3:1) to receive either NmCV-5 or MenACWY-D (Sanofi Pasteur). In the age 18–29 years group, participants were additionally randomly assigned (1:1:1:1) to either lot A, lot B, or lot C of NmCV-5 or MenACWY-D. Block randomisation was used (block sizes of 4, 8, and 12). Study participants and study personnel were masked to treatment assignment. Participants received either a 0·5 mL dose of NmCV-5, containing 5 μg each of conjugated A, C, W, Y, and X polysaccharides, or 0·5 mL MenACWY-D, containing 4 μg of each of conjugated A, C, W, and Y polysaccharides. Vaccinations were administered intramuscularly in the deltoid muscle. The primary outcomes were seroresponse (non-inferiority margin of –10%) and geometric mean titres (GMTs; non-inferiority margin of 0·5) in all participants, and lot-to-lot consistency of NmCV-5 (in participants aged 18–29 years; consistency was shown if the geometric mean ratio [GMR] 95% CIs were within the limit interval of 0·5 to 2). For non-inferiority, serogroup X immune response in the NmCV-5 group was compared with the lowest immune response among serogroups A, C, W, and Y in the MenACWY-D group. Immunogenicity was assessed with a serum bactericidal activity assay that used baby rabbit serum as the complement (rSBA) on days 1 and 29 in the modified per-protocol population (including all participants who were randomly assigned, received vaccine, had a post-vaccination rSBA measurement up to 121 days after vaccination, and no major protocol violations). Solicited events were collected for 7 days and serious adverse events were collected for 180 days, and assessed in the safety population (all participants who received vaccination). This study is registered with ClinicalTrials.gov, NCT04358731, and CTRI, CTRI/2019/12/022436, and is now complete.
Findings
Between Dec 27, 2019, and Sept 19, 2020, 1712 individuals were screened, of whom 1640 were randomly assigned and received NmCV-5 (n=1233) or MenACWY-D (n=407; mean age 26·4 years [SD 12·2], 551 [33·6%] of 1640 were female, and 1089 [66·4%] were male). 1441 participants were aged 18–29 years (362 received lot A, 360 received lot B, and 361 received lot C of NmCV-5 and 357 received MenACWY-D, with one participant mis-randomised by age group and excluded from lot-to-lot consistency analysis). Non-inferiority of NmCV-5 against MenACWY-D was met in terms of seroresponse rates and GMT ratios for all five serogroups. The seroresponse rates were 84·3% (97·5% CI 81·7 to 86·7; serogroup A) or higher in the NmCV-5 group and 54·5% (48·5 to 60·3; serogroup A) or higher in the MenACWY-D group, with the difference in the seroresponse rate between vaccine groups ranging from 0·2 (97·5% CI –2·2 to 2·6) for serogroup W to 29·8 (24·4 to 35·2) for serogroup A. GMTs on day 29 were 7016·9 (97·5% CI 6475·7 to 7603·4; serogroup Y) or higher in the NmCV-5 group and 3646·8 (3188·2 to 4171·5; serogroup Y) or higher in the MenACWY-D group, with GMT ratios between vaccine groups for serogroups A, C, Y, and W ranging from 1·9 (97·5% CI 1·5–2·3) for serogroup W to 2·5 (2·2–2·8) for serogroup A. NmCV-5 induced robust immune responses against serogroup X. Lot-to-lot consistency of NmCV-5 was found for all five serogroups, with 95% CIs for the GMT ratio for each pair of lots being between 0·5 and 2: the lowest lower bound and the highest upper bound of the 95% CI for the GMR between NmCV-5 lot A and lot B were 0·6 and 1·4, between lot A and lot C were 0·7 and 1·6, and between lot B and lot C were 0·8 and 1·6, respectively, for any of the five serogroups. At least one solicited adverse event was reported by 527 (42·7%) of 1233 participants in the NmCV-5 group and 142 (34·9%) of 407 in the MenACWY-D group. No serious adverse events occurred that were determined to be causally related to vaccination.
Interpretation
NmCV-5 was non-inferior to MenACWY-D in terms of seroresponse and GMTs, was safe, and demonstrated lot-to-lot consistency. NmCV-5 is prequalified by WHO and was rolled out in the African meningitis belt in April, 2024.
期刊介绍:
The Lancet Infectious Diseases was launched in August, 2001, and is a lively monthly journal of original research, review, opinion, and news covering international issues relevant to clinical infectious diseases specialists worldwide.The infectious diseases journal aims to be a world-leading publication, featuring original research that advocates change or sheds light on clinical practices related to infectious diseases. The journal prioritizes articles with the potential to impact clinical practice or influence perspectives. Content covers a wide range of topics, including anti-infective therapy and immunization, bacterial, viral, fungal, and parasitic infections, emerging infectious diseases, HIV/AIDS, malaria, tuberculosis, mycobacterial infections, infection control, infectious diseases epidemiology, neglected tropical diseases, and travel medicine. Informative reviews on any subject linked to infectious diseases and human health are also welcomed.