Phase I Clinical Trial Protocol of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) to Evaluate the Safety and Immunogenicity in Children Aged 2 Months (Minimum 6 Weeks) to 17 Years

Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in children aged 2 Months (Minimum 6 Weeks) to 17 Years . The objective of the study is to evaluate the safety tolerability and immunogenicity of PCV24. The trial is a randomized, blind, controlled combined placebo and positive vaccine control I clinical trial.

开始日期2024-04-27

申办/合作机构

上海瑞宙生物科技有限公司

NCT06678620

/ Recruiting临床2期

A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older

A phase II clinical trial of a 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The study's objective is to evaluate the safety and immunogenicity of PCV24. The trial is a single-center, randomized, blinded, parallel-controlled, non-inferiority design II clinical trial.

开始日期2024-04-20

申办/合作机构

上海瑞宙生物科技有限公司

100 项与 24价肺炎球菌多糖结合疫苗（瑞宙生物）相关的临床结果

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100 项与 24价肺炎球菌多糖结合疫苗（瑞宙生物）相关的转化医学

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100 项与 24价肺炎球菌多糖结合疫苗（瑞宙生物）相关的专利（医药）

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项与 24价肺炎球菌多糖结合疫苗（瑞宙生物）相关的文献（医药）

2025-08-01·VACCINE

Cost-effectiveness and budget impact analyses of the 24-valent pneumococcal conjugate vaccine in adults aged 50 and older

Article

作者: Altawalbeh, Shoroq M ; Nowalk, Mary Patricia ; Smith, Kenneth J ; Lin, Chyongchiou J ; Wateska, Angela R ; Schaffner, William ; Zimmerman, Richard K ; Harrison, Lee H

A 24-valent pneumococcal conjugate vaccine (PCV24) is currently in development and could potentially be used in all adults aged 50 years and older. This study evaluated risk- and age-based PCV24 use to ascertain its potential public health effects, budget impact, and cost-effectiveness. A Markov decision analysis model compared PCV24 and all currently recommended pneumococcal vaccines. Age-based vaccination could occur at age 50 or at ages 50 and 65. The analysis separately examined hypothetical cohorts of U.S. Black and non-Black individuals with and without consideration of childhood pneumococcal vaccination indirect effects, using race-specific pneumococcal disease and vaccination data. Cohorts were tracked over a lifetime horizon from both societal and healthcare perspectives. Model parameters were derived from U.S. data and parameter uncertainty was evaluated through deterministic and probabilistic sensitivity analyses. Budgetary impact of 21-valent conjugate vaccine (PCV21), PCV24, and combinations of both at different ratios was also assessed. From societal and healthcare perspectives, PCV24 prevented fewer pneumococcal disease cases and deaths but was less economically favorable than strategies using PCV21. Other vaccines were similarly less favorable than PCV21. When adding childhood vaccination indirect effects, PCV24 strategies remained unfavorable compared to PCV21 strategies. In probabilistic sensitivity analyses, PCV21 at ages 50 and 65 was preferred in 99 % of model iterations for Black cohorts and 85 % for non-Blacks at a $100,000/QALY willingness-to-pay threshold. Budget impact for PCV24 and PCV21 were not substantially different but PCV21 prevented more hospitalizations and deaths. Compared to PCV21, which is formulated solely on adult pneumococcal epidemiology, PCV24 and other childhood epidemiology-formulated vaccines were less economically favorable among adults aged 50 and older. Budget impacts of PCV21 and PCV24 use were similar.

2025-05-01·VACCINE

Distribution of pneumococcal serotypes causing invasive and non-invasive diseases in children in Mexico after introduction of PCV13 (2012−2023). Results from the GIVEBPVac group

Article

作者: Morfín-Otero, Rayo ; Pichardo-Villalón, Lilia ; Garza-González, Elvira ; Díaz-Jiménez, Virginia ; Monroy-Colín, Víctor Antonio ; Carnalla-Barajas, María Noemí ; Pacheco-Gil, Leova ; Rivera-Martínez, Eduardo ; León-Maldonado, Leith Soledad ; Tinoco-Favila, Juan Carlos ; Moreno-Espinoza, Sarbelio ; Sánchez-González, Gilberto ; González-Hernández, Alma Rosa ; Flores-Santos, Andrés ; Solórzano-Santos, Fortino ; Feliciano-Guzmán, José Manuel ; Avilés-Robles, Martha Josefina ; Sánchez-Francia, Domingo ; Rincón-Zuno, Joaquín ; Vázquez-Larios, Rosario ; Luévanos-Velázquez, Antonio ; Soto-Noguerón, Araceli ; Manzano-Arredonda, Damaris ; Gil-Veloz, Mariana ; Vázquez-Narváez, Jorge ; Lara-Barbosa, Antonino ; Echaniz-Aviles, Gabriela ; Macías-Parra, Mercedes

BACKGROUND:

The introduction of pneumococcal conjugate vaccines (PCVs) since 2000 has altered the epidemiology of invasive (IPD) and non-invasive pneumococcal diseases (NIPD). This study aims to analyze trends in pneumococcal serotype distribution among children in Mexico, focusing on the period following the introduction of PCV13, and assess the potential impact of future vaccines.

MATERIAL AND METHODS:

Pneumococcal isolates were collected from hospitalized children in participating hospitals from January 2012 to December 2023. Serotype distribution was analyzed in children under <5 years and those aged ≥5 to 17.9 years. The average annual change (AAC) in serotype proportions was calculated, and trends were analyzed using the Cochran-Armitage test.

RESULTS:

Serotype 19A was the most frequent PCV13 serotype, followed by serotypes 3 and 19F, in both age groups. Serotype 33F, included in PCV15 and PCV20, was absent in children aged ≥5-17.9 years. Among PCV20 serotypes, serotype 15B was the most common, and serotype 17F, covered by PCV24, showed a significant increase in the older age group (p = 0.037). No significant trends in the increase or decrease of individual serotypes were found, except for serotypes 17F and serotype 34, which increased in both age groups. A decrease in serotypes covered by PCV13 (excluding serotypes 3, 19A, and 19F) was observed in both age groups (p = 0.04, 0.002). A significant increase in non-PCV13 serotypes occurred in children aged ≥5-17.9 years (p = 0.023).

CONCLUSIONS:

After a decade of the introduction of PCV13 in Mexico, 10 of the 13 vaccine serotypes have not been detected in the past six years. However, serotypes 3, 19A, and 19F persist at high frequencies as causes of IPD and NIPD in children. Ongoing robust surveillance is critical for identifying emerging pneumococcal serotypes, selecting appropriate vaccines for each country, and developing next-generation vaccine formulations.

2025-03-01·AMERICAN JOURNAL OF PREVENTIVE MEDICINE

Cost-Effectiveness and Public Health Impact of 24-Valent Pneumococcal Conjugate Vaccine Compared With the Recommended Pneumococcal Vaccines in Older Adults

Article

作者: Nowalk, Mary Patricia ; Lin, Chyongchiou J ; Wateska, Angela R ; Smith, Kenneth J ; Schaffner, William ; Zimmerman, Richard K ; Harrison, Lee H

INTRODUCTION:

The potential impact of an in-development 24-valent pneumococcal conjugate vaccine compared with that of currently recommended vaccines in older adults is unclear. Similar to most currently available pneumococcal conjugate vaccines, 24-valent pneumococcal conjugate vaccine's formulation is based on childhood pneumococcal disease epidemiology. Decision analysis techniques were used to estimate 24-valent pneumococcal conjugate vaccine cost-effectiveness and public health effects in U.S. older adults.

METHODS:

A Markov model compared 24-valent pneumococcal conjugate vaccine with currently recommended U.S. pneumococcal vaccination strategies in older adults (aged ≥65 years) and with no vaccination. Age-, race-, and chronic medical condition-specific pneumococcal illness risks and serotype-specific disease risks were obtained from Centers for Disease Control and Prevention data. Vaccine effectiveness was estimated using Delphi panel and clinical trial data. Vaccination and pneumococcal illness costs were from U.S.

DATABASES:

Scenario analyses examined indirect effects of childhood pneumococcal vaccination on adult disease. Data were collected and analyses were performed in 2024.

RESULTS:

The 24-valent pneumococcal conjugate vaccine prevented fewer pneumococcal disease cases and deaths than the recently recommended 21-valent pneumococcal conjugate vaccine, which is formulated on the basis of adult pneumococcal disease serotypes. In cost-effectiveness analyses, 21-valent pneumococcal conjugate vaccine was economically favorable compared with 24-valent pneumococcal conjugate vaccine and all other vaccination strategies, both without and with consideration of potential childhood vaccination indirect effects. These findings were robust and consistent with those in deterministic and probabilistic sensitivity analyses.

CONCLUSIONS:

In older adults, 24-valent pneumococcal conjugate vaccine was clinically and economically unfavorable compared with 21-valent pneumococcal conjugate vaccine, which covers more adult disease-causing pneumococcal serotypes and is less susceptible to childhood vaccination indirect effects.

项与 24价肺炎球菌多糖结合疫苗（瑞宙生物）相关的新闻（医药）

2025-03-25

·药时空

瑞宙生物24价肺炎球菌多糖结合疫苗II期临床试验顺利完成揭盲

近日，上海瑞宙生物科技有限公司及长春瑞宙生物制药有限公司（以下简称“瑞宙生物”）宣布，其自主研发的一类创新疫苗24价肺炎球菌多糖结合疫苗（PCV24）II期临床试验顺利完成揭盲。肺炎是一种肺部炎症性疾病，通常由细菌、病毒、真菌或其他微生物感染而引起，细菌性肺炎占人体感染的肺炎的80%，其中肺炎链球菌是重要的病原体。早在2008年，WHO就已将肺炎球菌疾病列为需“极高度优先”使用疫苗预防的疾病。在我国，肺炎球菌疫苗尚未被纳入我国国家免疫规划，属于自费接种疫苗。从市场规模看，据观研天下数据显示，到2026年，中国肺炎球菌疫苗市场规模将突破200亿元，年复合增长率达到18.24%。瑞宙生物PCV24是全球首个具有自主知识产权的无毒双载体蛋白24价肺炎多糖结合疫苗。这一创新设计不仅提升了疫苗的安全性，还进一步增强了其免疫效果。无毒双载体蛋白能够有效降低载体蛋白对缀合多糖免疫原性的干扰，从而更高效地增强多糖的免疫效果，使疫苗在预防肺炎球菌疾病方面具有显著优势。本次II期临床试验采用随机、双盲、平行对照的设计，旨在评估PCV24在18周岁及以上人群中的安全性和免疫原性，试验共入组992名18周岁及以上的健康志愿者，入组率达到100%，并已全部完成接种。据试验数据结果显示，PCV24在成人群体中表现出优异的安全性和免疫原性，在多项免疫原性评价指标中，PCV24试验疫苗在24种不同血清型中都显示很好的免疫原性，达到预期目的。PCV24在接种后30天内未出现严重不良反应和非预期可疑的不良事件。大部分疫苗常见不良反应症状为接种部位的轻度红、肿、热、痛，均为常见的短暂且可自行缓解的局部反应。随着II期临床试验的顺利完成，瑞宙生物计划加快推进PCV24的III期临床试验，并积极筹备上市申请。瑞宙生物是一家基于研发处于临床阶段的高新生物技术企业，专注于创新疫苗及重组蛋白类生物制品研发及产业化。公司拥有自主核心技术及平台，建有从研发、中试到规模化生产的完整的产业链，开发具有国际领先水平的创新疫苗等生物制品。参考来源：瑞宙生物。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

疫苗临床2期

100 项与 24价肺炎球菌多糖结合疫苗（瑞宙生物）相关的药物交易

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