中国疾病预防控制中心周报最新文献

{"title":"Malaria Ends with Us - Time to Reinvest, Reimagine, and Reignite.","authors":"Simon I Hay","doi":"10.46234/ccdcw2025.099","DOIUrl":"https://doi.org/10.46234/ccdcw2025.099","url":null,"abstract":"<p><p>On World Malaria Day 2025 under the banner \"Malaria Ends with Us\", China's experience offers timely lessons for global malaria elimination. Certified malaria-free in 2021, China achieved this milestone through decades of reinvestment, local innovation, and strong political will. This commentary highlights key strategies: reinvestment after resurgence in the Huai River Basin, adaptive local leadership in Hainan, and cross-border collaboration in Yunnan. China's integrated approach - combining ecological vector control, community engagement, and sustained surveillance - shows that ending malaria requires more than technology. It demands long-term commitment, innovation, and collective action.</p>","PeriodicalId":69039,"journal":{"name":"中国疾病预防控制中心周报","volume":"7 18","pages":"599-601"},"PeriodicalIF":4.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075440/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144081918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Implementation Interruptions of 1,7-Malaria Reactive Community-Based Testing and Response Approach on Malaria Control Efforts - Southern Tanzania.","authors":"Yuejin Li, Jinxin Zheng, Yeromin P Mlacha, Shenning Lu, Salim Abdulla, Qin Li, Ge Yan, Xiaonong Zhou, Ning Xiao, Victoria Githu, Tegemeo Gavana, Prosper Chaki, Peng Bi, Yuan Sui, Yongbin Wang, Duoquan Wang","doi":"10.46234/ccdcw2025.104","DOIUrl":"https://doi.org/10.46234/ccdcw2025.104","url":null,"abstract":"<p><strong>Introduction: </strong>Surveys from the China-Tanzania Malaria Control Project demonstrated that the 1,7-malaria Reactive Community-Based Testing and Response (1,7-mRCTR) approach significantly reduced malaria incidence rates. However, implementation was disrupted by security concerns, infectious disease outbreaks, and supply shortages. This study evaluates how these interruptions affected intervention effectiveness to inform future malaria control strategies.</p><p><strong>Methods: </strong>The study employed a two-phased design: Phase I (2016-2018) and Phase II (2019-2021). Weekly malaria incidence rates per 100 people were calculated from cases reported by local health facilities in the intervention areas during both phases. Seasonal and trend decomposition using loess (STL) and interrupted time series modeling with piecewise linear regression were used to evaluate the impact of disruptions on 1,7-mRCTR implementation effectiveness.</p><p><strong>Results: </strong>In Tanzania's 1,7-mRCTR areas, malaria incidence peaked during November-December and June-July. Phase I's 8-month interruption reversed the weekly trend from a 0.17% decline to a 0.58% increase (<i>P</i>=0.001). After resumption, incidence dropped 8.96% (<i>P</i>=0.039) and maintained a 0.39% long-term decline (<i>P</i>=0.003). Even with seasonal adjustment, the interruption slowed the weekly decline from 0.08% to 0.07% (<i>P</i>=0.003). Phase II showed a similar pattern: a one-week interruption caused a 0.70% drop (<i>P</i>=0.007) but shifted the trend from a 0.02% decline to a 0.08% increase (<i>P</i>=0.001). After resumption, interventions stabilized the decline at 0.11% weekly (<i>P</i>=0.001).</p><p><strong>Conclusions: </strong>This research demonstrates that Tanzania's malaria incidence is closely linked to seasonal patterns and consistent intervention efforts. Phase I's 8-month security-related interruption reduced 1,7-mRCTR effectiveness by 12.5%, while Phase II's 3-month pandemic-induced interruption caused only short-term fluctuations with minimal long-term impact. Rapid resumption of interventions after disruptions allowed for prompt recovery, highlighting the importance of adaptive strategies to maintain progress toward malaria control goals.</p>","PeriodicalId":69039,"journal":{"name":"中国疾病预防控制中心周报","volume":"7 18","pages":"628-634"},"PeriodicalIF":4.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk Factors for Imported Severe Malaria Cases - China, 2019-2023.","authors":"Boyu Yi, Zhigui Xia","doi":"10.46234/ccdcw2025.100","DOIUrl":"https://doi.org/10.46234/ccdcw2025.100","url":null,"abstract":"<p><strong>Objective: </strong>To analyze the epidemiological characteristics of imported malaria in China from 2019 to 2023 and to explore risk factors for severe malaria cases, thereby providing a theoretical basis for early clinical identification and intervention of severe malaria.</p><p><strong>Methods: </strong>National malaria case data were retrospectively collected from 2019 to 2023 through the Chinese Center for Disease Control and Prevention Parasitic Disease Prevention and Control Information System. Study subjects were divided into severe and non-severe malaria cases, and the characteristics of both groups were analyzed. Multivariate logistic regression analysis was used to explore risk factors for developing severe malaria.</p><p><strong>Results: </strong>From 2019 to 2023, a total of 7,892 imported malaria cases were reported nationwide, including 673 severe cases and 7,219 non-severe cases. There were 7,353 (93.2%) male and 539 (6.8%) female patients. Compared to non-severe malaria patients, severe malaria patients were older (43.9±10.4 years), predominantly originated from Africa (643,95.5%), had a higher frequency of recent overseas residence within the past month (609,90.5%), were typically infected with <i>P. falciparum</i> (527,78.3%), and had a higher mortality rate (47,7.0%). Severe cases had longer median time intervals from symptom onset to medical visit (4 days), from visit to diagnosis (2 days), and from diagnosis to treatment (2 days), and a longer median medication time (7 days), all <i>P</i><0.05.</p><p><strong>Conclusions: </strong>This study identified risk factors for severe malaria and recommends focusing on monitoring patients' age, infection source, <i>Plasmodium</i> species, time from onset to hospital visit, and recent history of foreign residence. These findings provide a valuable reference for effectively managing malaria cases and reducing the incidence of severe malaria in the future.</p>","PeriodicalId":69039,"journal":{"name":"中国疾病预防控制中心周报","volume":"7 18","pages":"602-608"},"PeriodicalIF":4.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075445/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>Echinococcus</i> Infection and Metacestode Fertility in Yaks and Sheep - Four Provincial-Level Administrative Divisions, Northwestern China, 2023.","authors":"Qiufeng Lan, Zhuoma Bianba, Xiaojin Mo, Guirong Zheng, Bolor Bold, Gengcheng He, Haijun Gao, Wei Hu, Ting Zhang, Xiaonong Zhou","doi":"10.46234/ccdcw2025.102","DOIUrl":"https://doi.org/10.46234/ccdcw2025.102","url":null,"abstract":"<p><strong>What is already known about this topic?: </strong>Echinococcosis is a parasitic zoonosis caused by the larval stage of cestode species belonging to the genus <i>Echinococcus</i>, which is highly prevalent in northwestern China. <i>Echinococcus</i> spp. includes numerous species/genotypes that have different infectivity and parasitism patterns in livestock hosts, potentially affecting the transmission dynamics of the parasite.</p><p><strong>What is added by this report?: </strong>In four PLADs of China, the prevalence of <i>Echinococcus</i> was 16.5% in yaks and 9.41% in sheep. The predominant species/genotype was <i>E. granulosus</i> s.s. (G1/G3), which mainly infected sheep liver and yak lung. However, fertile cysts were more frequent in sheep than in yaks.</p><p><strong>What are the implications for public health practice?: </strong>Understanding the livestock infection rate, prevalent species/genotypes, and cyst fertility is essential for elucidating the mechanisms of <i>Echinococcus</i> transmission and pathogenesis. This knowledge lays the foundation for developing accurate prevention and control strategies.</p>","PeriodicalId":69039,"journal":{"name":"中国疾病预防控制中心周报","volume":"7 18","pages":"614-619"},"PeriodicalIF":4.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075443/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Epidemiological and Clinical Features of Meningococcal Meningitis in Infants - China, 2006-2023.","authors":"Qian Zhang, Jiajia Zhou, Mingshuang Li, Tingting Yan, Dan Wu, Zhijie An, Zundong Yin, Hui Zheng","doi":"10.46234/ccdcw2025.095","DOIUrl":"https://doi.org/10.46234/ccdcw2025.095","url":null,"abstract":"<p><strong>Introduction: </strong>Infants have the highest incidence of meningococcal meningitis (MM) among all age groups in China. Infants receive their first and second doses of serogroup A meningococcal polysaccharide vaccine at 6 and 9 months of age.</p><p><strong>Methods: </strong>We extracted data on MM cases among 0-11-month-old children reported during 2006-2023 from the National Notifiable Diseases Registry System and the National Meningococcal Disease Surveillance System and conducted an epidemiological and clinical analysis.</p><p><strong>Results: </strong>During the study period, 721 infant MM cases were reported. Incidence decreased from 7.31 cases per million to 2.74 per million, while the all-age incidence declined from 1.27 cases per million to 0.06 per million. Among 210 cases with serogrouping results, five serogroups (A, B, C, W, Y) and non-groupable strains were detected. Serogroup A cases decreased from 36.36% to 1.87% during the study period, while serogroup B increased from 14.55% to 67.29%. Fever, nausea, and/or vomiting were common symptoms across all serogroups. The frequencies of petechiae and/or purpura in serogroup A (73%) and C (92%) were substantially higher than in other serogroups. Among serogroup B cases, 26.42% developed petechiae and/or purpura, 26.42% exhibited neck stiffness, and 13.21% had positive Kernig's and/or Brudzinski's signs.</p><p><strong>Conclusions: </strong>The incidence of MM in infants has significantly decreased but remains higher than incidence across all age groups. Serogroup B cases were the most common. Atypical symptoms in infant cases challenge timely diagnosis. We suggest eligible infants receive meningococcal vaccination timely, and the development of serogroup B meningococcal vaccines should be accelerated.</p>","PeriodicalId":69039,"journal":{"name":"中国疾病预防控制中心周报","volume":"7 17","pages":"568-573"},"PeriodicalIF":4.3,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075485/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Post-Marketing Surveillance of Adverse Events Following Rotavirus Vaccination - China, 2013-2023.","authors":"Yuan Li, Keli Li, Yan Li, Chunxiang Fan, Lina Zhang, Minrui Ren, Lei Cao, Wenzhou Yu, Zundong Yin","doi":"10.46234/ccdcw2025.093","DOIUrl":"https://doi.org/10.46234/ccdcw2025.093","url":null,"abstract":"<p><strong>Introduction: </strong>Two live attenuated rotavirus vaccines (RVs) were licensed in China. Passive surveillance for adverse events following immunization (AEFI) provides valuable evidence for potential safety signal detection of RV in China.</p><p><strong>Methods: </strong>We obtained data on RV doses administered and RV AEFI reports from the Chinese National Immunization Information System (CNIIS) during January 2013 to December 2023. We conducted a descriptive analysis of RV AEFI characteristics and estimated incidences of RV AEFI.</p><p><strong>Results: </strong>During the study period, 77.36 million doses of RV were administered, and 20,556 RV AEFI reports were made, yielding an overall incidence of 26.57 AEFI per 100,000 doses administered; incidences were 26.42 for RV1 and 26.85 for RV5. Among all RV AEFI, 20,334 (98.92%) were non-serious. Vaccine product-related reactions accounted for 95.68% of AEFI reports, including 18,192 (88.50%) common and 1,476 (7.18%) rare vaccine reactions. Among common vaccine reactions, case reports per 100,000 doses administered were 16.85 (13,031 reports) for fever, 5.84 (4,520 reports) for gastrointestinal disorders, and 1.28 (988 reports) for rash. Among rare vaccine reactions, case reports per 100,000 doses were 1.43 (1,104 reports) for allergic rash, 0.07 (56 reports) for thrombocytopenic purpura, 0.03 (26 reports) for febrile convulsion, and 0.01 (5 reports) for intussusception.</p><p><strong>Conclusions: </strong>Most RV AEFIs were mild and non-serious, and the incidence of rare vaccine reactions was very low. RVs have reasonable safety surveillance profiles and AEFI evaluation should be continued.</p>","PeriodicalId":69039,"journal":{"name":"中国疾病预防控制中心周报","volume":"7 17","pages":"580-585"},"PeriodicalIF":4.3,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075480/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vaccination Status and Incidences of Measles, Mumps, and Rubella - Worldwide, 2014-2023.","authors":"Qianqian Liu, Qi Bi, Siyu Liu, Yuexin Xiu, Fuzhen Wang, Zundong Yin, Xiaoxue Liu","doi":"10.46234/ccdcw2025.094","DOIUrl":"https://doi.org/10.46234/ccdcw2025.094","url":null,"abstract":"<p><strong>Introduction: </strong>Measles, mumps, and rubella remain significant global health threats despite being vaccine-preventable diseases. The World Health Organization aims to achieve regional elimination of measles and rubella by 2030, yet substantial disparities in vaccination coverage and disease incidence persist across regions. We analyzed global vaccination and disease data to provide evidence for optimizing immunization strategies.</p><p><strong>Methods: </strong>The study analyzed World Health Organization data on measles, mumps, and rubella from 2014-2023. Our analysis included vaccine types, recommended vaccination schedules, coverage rates, supplemental immunization activities, and disease incidence. We employed descriptive epidemiological methods for data synthesis and analysis.</p><p><strong>Results: </strong>All countries implemented ≥1 measles-containing vaccine dose, with 190 (97.9%) countries using a ≥2-dose schedule. Global 2nd dose of measles-containing vaccine coverage increased from 59% to 74% during the study period. High-income regions maintained >90% coverage, while the African Region reported the lowest coverage (70% for the 1st dose and 49% for the 2nd dose of measles-containing vaccine). Supplemental immunization activities helped address coverage gaps but required integration with routine immunization systems. Rubella vaccine was implemented in 90.2% of countries, while mumps vaccine adoption remained lower at 63.9%. The African Region experienced high incidence rates for both measles (551.8 per million) and rubella (21.9 per million). The COVID-19 pandemic disrupted vaccination coverage (3%-5% decline globally), with the African Region experiencing a post-pandemic U-shaped resurgence in cases. China's transition to the measles, mumps, and rubella vaccine has reduced mumps incidence to below 100 cases per million by 2020.</p><p><strong>Conclusions: </strong>While global control of measles, mumps, and rubella has progressed, inequities in vaccination coverage and pandemic-related disruptions threaten elimination goals. Strengthening routine immunization systems is critical. Achieving the World Health Organization's 2030 targets will require sustained investment in health systems and implementation of equity-focused innovations.</p>","PeriodicalId":69039,"journal":{"name":"中国疾病预防控制中心周报","volume":"7 17","pages":"561-567"},"PeriodicalIF":4.3,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Effectiveness Analysis of Sequential Screening Strategies for Hepatitis B Virus Infection by Birth Cohort - China.","authors":"Lei Wang, Hui Zheng, Lanfang Xia, Guomin Zhang, Fuzhen Wang, Zundong Yin, Huaqing Wang","doi":"10.46234/ccdcw2025.096","DOIUrl":"https://doi.org/10.46234/ccdcw2025.096","url":null,"abstract":"<p><strong>Introduction: </strong>Eliminating hepatitis B virus (HBV) as a major public health threat is a global health priority that requires cost-effective screening strategies. This study evaluated the cost-effectiveness of sequential birth cohort HBV screening strategies in China.</p><p><strong>Methods: </strong>Using a Markov model, we compared five screening strategies with current practice, calculating HBV-related deaths averted, quality-adjusted life years (QALYs) gained, and incremental cost-effectiveness ratios (ICER). One-way deterministic and probabilistic sensitivity analyses were conducted to evaluate the robustness of the results.</p><p><strong>Results: </strong>The sequential birth cohort screening strategy (Sequential Screening 1: screening the 1991-2000 cohort in 2025-2026, the 1971-1990 cohort in 2027-2028, and the 1951-1970 cohort in 2029-2030) was the most cost-effective, with an ICER of 58,523 Chinese Yuan (CNY) per QALY at a willingness-to-pay threshold of three times the per-capita Gross Domestic Product (GDP). An alternative strategy that prioritized the 1951-1970 cohort in 2025-2026 averted the most HBV-related deaths (approximately 3.44 million) and gained 24.9 million QALYs, with an ICER of 60,113 CNY per QALY, also showing cost-effectiveness.</p><p><strong>Discussion: </strong>Our findings support sequential birth cohort screening as an optimal and innovative approach to achieving the WHO HBV elimination targets, offering evidence-informed guidance for policymakers to optimize screening programs and resource allocation.</p>","PeriodicalId":69039,"journal":{"name":"中国疾病预防控制中心周报","volume":"7 17","pages":"586-591"},"PeriodicalIF":4.3,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Post-Marketing Surveillance of Adverse Events Following Recombinant Zoster Vaccine - China, 2020-2023.","authors":"Yan Li, Keli Li, Minrui Ren, Yuan Li, Lina Zhang, Chunxiang Fan, Zhaonan Zhang, Lei Cao, Wenzhou Yu, Zundong Yin","doi":"10.46234/ccdcw2025.092","DOIUrl":"https://doi.org/10.46234/ccdcw2025.092","url":null,"abstract":"<p><strong>Objective: </strong>To assess adverse events following recombinant zoster vaccine (RZV) in China during the post-marketing period.</p><p><strong>Methods: </strong>The study obtained data on adverse events following immunization (AEFI) and vaccination doses of RZV from the Chinese National Immunization Information System (CNIIS). We analyzed RZV AEFI reports from 2020 through 2023.</p><p><strong>Results: </strong>During the study period, 1.99 million doses of RZV were administered, and 10,525 RZV AEFI cases were reported. The reporting incidence of AEFI was 527.76 per 100,000 doses administered, with serious AEFI at 0.55, common vaccine reactions (usually minor) at 518.19, and rare vaccine reactions (possibly serious) at 4.06 per 100,000 doses. Among adverse vaccine reactions, the most frequently reported common vaccine reactions were fever (333.76/100,000) and local redness and swelling (213.51/100,000), while the main reported rare vaccine reaction was allergic rash (3.01/100,000).</p><p><strong>Conclusions: </strong>Most RZV AEFIs were common vaccine reactions, consistent with adverse events reported in RZV clinical trials. The incidence of rare vaccine reactions was very low, and most of which were allergic rash. No special safety concerns were identified and AEFI surveillance should be continued.</p>","PeriodicalId":69039,"journal":{"name":"中国疾病预防控制中心周报","volume":"7 17","pages":"574-579"},"PeriodicalIF":4.3,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Novel Adaptive Design Approach for Early-Phase Clinical Trials to Optimize Vaccine Dosage.","authors":"Xin Tong, Dongfang You, Fang Shao, Mengyi Lu, Yang Zhao","doi":"10.46234/ccdcw2025.097","DOIUrl":"https://doi.org/10.46234/ccdcw2025.097","url":null,"abstract":"<p><strong>Introduction: </strong>Vaccines are a cornerstone of global health, with their efficacy and safety dependent on appropriate dosage determination. Early-phase vaccination trials face significant challenges due to minimal toxicity and nonmonotonic dose response curves, creating a major obstacle in vaccine development. To address this gap, we propose a novel Bayesian phase I/II trial design for dose response curves exhibiting plateau or unimodal patterns to identify the optimal biological dose (OBD), effectively balancing efficacy and toxicity.</p><p><strong>Methods: </strong>We employ a logistic dose-efficacy design that makes dose-escalation and de-escalation decisions while simultaneously considering both efficacy and safety parameters. Extensive simulation studies evaluate the performance of this design.</p><p><strong>Results: </strong>Comparative analyses with commonly used vaccine dose-finding designs demonstrate that our method excels in identifying the optimal toxicity-efficacy trade-off, offering both simplicity and accuracy. Sensitivity analyses across various prior settings confirm the robustness and efficiency of our approach. Additionally, our design provides a user-friendly framework for clinicians, with superior operating performance compared to existing designs, particularly in terms of accuracy and robustness.</p><p><strong>Discussion: </strong>Our innovative Bayesian design represents a significant advancement in addressing the inherent challenges of early-phase vaccination clinical trials, offering improved accuracy and efficacy in vaccine dosage determination.</p>","PeriodicalId":69039,"journal":{"name":"中国疾病预防控制中心周报","volume":"7 17","pages":"592-598"},"PeriodicalIF":4.3,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075483/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}