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COVID-19 vaccine policy: a response and way forward COVID-19疫苗政策:应对措施和前进方向。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-31 DOI: 10.1016/j.vaccine.2026.128292
Gregory A. Poland , Tamar Ratishvili , Peter J. Pitts
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引用次数: 0
Safety, immunogenicity, and lot consistency of a 13-valent pneumococcal conjugate vaccine in Chinese children aged 2–5 years: A phase III study 中国2-5岁儿童13价肺炎球菌结合疫苗的安全性、免疫原性和批次一致性:一项III期研究
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-18 DOI: 10.1016/j.vaccine.2026.128244
Liwei Shi , Jingjing Chen , Hong Li , Xuemei Yan , Fang Shen , Xin Lai , Lin Yuan , Yi Mo

Background

Pneumococcal conjugate vaccines have significantly reduced the global morbidity and mortality burdens of pneumococcal disease in children under five years of age, but supply constraints remain. We evaluated the safety, immunogenicity, and lot-to-lot consistency of a tetanus toxoid–conjugated 13-valent pneumococcal conjugate vaccine (PCV13) in Chinese children aged 2–5 years.

Methods

In this randomized, Phase III study, 1800 healthy children aged 2–5 years were enrolled and randomized (1:1:1) to receive a single dose of one of three consecutive manufacturing lots of PCV13. Safety and reactogenicity were assessed up to 30 days post-vaccination, and serious adverse events (SAEs) up to 180 days. Immunogenicity was evaluated 30 days post-vaccination by measuring serotype-specific IgG concentrations using ELISA. The primary objective was to demonstrate lot-to-lot consistency based on predefined equivalence criteria for geometric mean concentration (GMC) ratios; seropositivity and safety outcomes were secondary endpoints.

Results

The prespecified primary objective was met: for all 13 vaccine serotypes, pairwise serotype-specific IgG geometric mean ratios (GMRs) between the three manufacturing lots fell within the predefined equivalence margins (0.5–2.0). By Day 30, seropositivity rates (IgG ≥0.35 μg/mL) were ≥ 99% for 12 serotypes and 85.6–88.3% for serotype 3. Solicited local and systemic reactions were predominantly mild or moderate in severity and occurred at similar frequencies across groups; rates of SAEs and unsolicited adverse events considered related to vaccination were low.

Conclusion

This tetanus toxoid–conjugated PCV13 met prespecified criteria for lot-to-lot manufacturing consistency and showed favorable immunogenicity and safety profiles in children aged 2–5 years, supporting its licensed use in this age group. The vaccine may help strengthen the global supply of pneumococcal conjugate vaccines, particularly in regions with unmet pediatric vaccination needs.
背景:肺炎球菌结合疫苗显著降低了全球五岁以下儿童肺炎球菌疾病的发病率和死亡率负担,但供应限制仍然存在。我们评估了破伤风类毒素结合的13价肺炎球菌结合疫苗(PCV13)在中国2-5岁儿童中的安全性、免疫原性和批次间一致性。方法:在这项随机的III期研究中,纳入了1800名2-5岁的健康儿童,并随机(1:1:1)接受PCV13连续三个生产批次之一的单剂量。疫苗接种后30天评估安全性和反应原性,180天评估严重不良事件(sae)。免疫原性在接种后30天通过ELISA检测血清型特异性IgG浓度进行评估。主要目的是证明基于几何平均浓度(GMC)比率的预定义等效标准的批次间一致性;血清阳性和安全性结果是次要终点。结果:达到了预定的主要目标:对于所有13种疫苗血清型,三个生产批次之间的两两血清型特异性IgG几何平均比(GMRs)落在预定的等效范围内(0.5-2.0)。第30天,12种血清型血清阳性率(IgG≥0.35 μg/mL)≥99%,3种血清型血清阳性率为85.6 ~ 88.3%。征求的局部和全身反应主要是轻度或中度的严重程度,并且在各组中发生的频率相似;被认为与疫苗接种有关的SAEs和主动不良事件的发生率很低。结论:该破伤风类毒素结合PCV13符合预先规定的批次生产一致性标准,在2-5岁儿童中显示出良好的免疫原性和安全性,支持其在该年龄组的许可使用。该疫苗可能有助于加强全球肺炎球菌结合疫苗的供应,特别是在儿童疫苗接种需求未得到满足的地区。
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引用次数: 0
Evaluating the delivery costs and operational context of a single-dose human papillomavirus (HPV) vaccine regimen administered to a multi-age cohort of adolescent girls in Ethiopia 评估埃塞俄比亚多年龄段少女单剂量人乳头瘤病毒(HPV)疫苗方案的交付成本和操作背景。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-21 DOI: 10.1016/j.vaccine.2026.128248
Mercy Mvundura , Rose Slavkovsky , Belayneh Dagnew , Alemayehu Hunduma , Melkamu Ayalew , Diriba Bedada

Introduction

The World Health Organization recently endorsed an alternative single-dose human papillomavirus (HPV) vaccination regimen based on high-quality evidence of its comparable efficacy and duration of protection as multiple doses. Real-world evidence is lacking on the program cost implications and operational context associated with the new regimen. Our study aimed to evaluate the delivery costs and describe the program context of delivering a single-dose HPV vaccine regimen to a multi-age cohort (MAC) of 9–14 year-old girls, using data from Ethiopia's vaccination campaign conducted in late 2024.

Methods

This was a cross-sectional retrospective study combining operations research and micro-costing methods. We collected primary data on program activities at 82 health facilities in four selected regions and at the associated subnational and national administrative levels. Operations data were tabulated as counts and frequencies to characterize the program context. Delivery costs including financial costs (monetary outlays) and economic costs (financial plus opportunity costs) were estimated. Costing was done from the health system perspective and reported in 2024 United States dollars (US$).

Results

Staff from 90% of health facilities in our sample conducted HPV vaccination sessions at schools and 73% conducted outreach, with an average of 910 HPV vaccine doses delivered per facility. While most health facilities and administrative offices conducted additional program activities, their intensity differed by level of the health system. On average, opportunity costs were the larger share of delivery costs (79%) at health facilities, while at administrative levels it was financial costs (at least 52%). Delivery costs aggregated across all levels of the health system were $0.66 for financial costs and $1.67 for economic costs per dose or per adolescent girl receiving the single-dose regimen.

Conclusion

A single-dose HPV vaccination regimen administered to a MAC resulted in low delivery costs and may be a way for HPV vaccination programs to reduce costs and enhance sustainability.
导论:世界卫生组织最近批准了一种替代性的单剂量人乳头瘤病毒(HPV)疫苗接种方案,基于高质量的证据,其疗效和保护持续时间与多剂量相当。关于新方案的项目成本影响和操作环境,缺乏实际证据。我们的研究旨在评估交付成本,并描述向9-14岁女孩的多年龄队列(MAC)提供单剂量HPV疫苗方案的项目背景,使用的数据来自埃塞俄比亚在2024年底进行的疫苗接种运动。方法:采用运筹学与微观成本法相结合的横断面回顾性研究。我们收集了在四个选定地区的82个卫生设施以及相关的次国家和国家行政级别的方案活动的主要数据。操作数据被制表为计数和频率,以表征程序上下文。交付成本包括财务成本(货币支出)和经济成本(财务加上机会成本)。从卫生系统的角度进行成本计算,并以2024年美元(US$)报告。结果:在我们的样本中,90%的卫生机构的工作人员在学校开展了人乳头瘤病毒疫苗接种课程,73%的卫生机构开展了外展活动,平均每家机构提供910剂人乳头瘤病毒疫苗。虽然大多数卫生设施和行政办公室开展了额外的规划活动,但其强度因卫生系统级别而异。平均而言,在卫生设施,机会成本在分娩成本中所占比例较大(79%),而在行政层面,则是财务成本(至少52%)。各级卫生系统的总交付成本为每剂或每名接受单剂方案的少女的财务成本为0.66美元,经济成本为1.67美元。结论:对MAC进行单剂量HPV疫苗接种方案可降低交付成本,可能是HPV疫苗接种计划降低成本和增强可持续性的一种方法。
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引用次数: 0
Clinical and economic benefits of bivalent respiratory syncytial virus prefusion F (RSVpreF) maternal vaccine for prevention of RSV illness in infants: A cost-effectiveness analysis for Singapore 二价呼吸道合胞病毒预融合F (RSVpreF)母体疫苗预防婴儿呼吸道合胞病毒疾病的临床和经济效益:新加坡的成本效益分析
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-30 DOI: 10.1016/j.vaccine.2026.128285
Karan Thakkar , Rengina Kefalogianni , Jessie Zhang , Chee Fu Yung , Shephali Tagore , Pradip Dashraath , Amy W. Law , Diana Mendes

Background

Respiratory syncytial virus (RSV) is a leading cause of respiratory tract infections in children. A novel bivalent RSV prefusion F protein subunit (RSVpreF) vaccine has recently been approved by the Health Sciences Authority (HSA) in Singapore. This study estimated the clinical and economic impact of a year-round RSVpreF maternal vaccination program on the prevention of RSV among infants in Singapore.

Methods

A Markov cohort model was used to project clinical and economic outcomes of RSV from birth to one year of age for RSVpreF vaccine compared to no intervention. Analyses were conducted from the healthcare system perspective, with direct costs (2025 Singapore dollars [S$]) and outcomes discounted at 3% annually; scenario and sensitivity analyses tested the robustness of the model. Findings: Compared to no intervention, a year-round RSVpreF program with 80% coverage would prevent 308 hospitalizations and 1995 outpatient visits annually, averting S$2.15 million in direct medical costs and saving 29 quality-adjusted life years (QALYs). The RSVpreF vaccine would be cost-effective up to S$237.68/dose under a cost-effectiveness threshold of 1 x gross domestic product per capita (S$121,378) per QALY gained.

Interpretation

Year-round RSVpreF maternal vaccination would help reduce pressures on the healthcare system as well as reduce RSV's clinical and economic burden among infants in Singapore, and likely be a cost-effective program.
呼吸道合胞病毒(RSV)是儿童呼吸道感染的主要原因。最近,新加坡卫生科学管理局(HSA)批准了一种新型二价RSV预融合F蛋白亚基(RSVpreF)疫苗。本研究估计了新加坡全年RSV前疫苗接种计划对预防婴儿RSV的临床和经济影响。方法采用马尔可夫队列模型预测从出生到1岁接种RSV疫苗与不干预相比的临床和经济结果。从医疗保健系统的角度进行分析,直接成本(2025新加坡元[S$])和结果每年折现3%;情景分析和敏感性分析检验了模型的稳健性。研究结果:与不干预相比,覆盖率为80%的全年RSVpreF计划每年可预防308例住院和1995例门诊,避免215万新元的直接医疗费用,并节省29个质量调整生命年(QALYs)。按照每获得的质量质量的1倍人均国内生产总值(121,378新元)的成本效益门槛,RSVpreF疫苗的成本效益最高可达237.68新元/剂。全年RSV疫苗接种将有助于减轻医疗系统的压力,并减轻新加坡婴儿RSV的临床和经济负担,并且可能是一个具有成本效益的计划。
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引用次数: 0
Development and efficacy test of a live, attenuated Mycoplasma hyorhinis vaccine candidate strain 猪支原体减毒活疫苗候选株的研制及效力试验
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-29 DOI: 10.1016/j.vaccine.2026.128278
Eszter Zsófia Nagy , Levente Szeredi , Dorottya Földi , Nikolett Belecz , Áron Botond Kovács , Kinga Mária Sulyok , Dénes Grózner , Enikő Wehmann , Krisztián Bányai , Szilvia Marton , Miklós Tenk , Zsuzsa Kreizinger , Miklós Gyuranecz

Background

Mycoplasma (M.) hyorhinis causes substantial economic losses in swine. Currently, prevention and treatment rely on minimizing risk factors and administering antibiotics, as no vaccines are commercially available in Europe. However, antibiotics often cannot fully eliminate the bacteria. The development of an effective vaccine could lead to a potentially long-term control method.

Materials and methods

A temperature-sensitive M. hyorhinis strain was developed using 1-methyl-3-nitro-1-nitrosoguanidine (NTG) mutagenesis. The immunogenicity and efficacy of this vaccine candidate clone were evaluated in combination with an adjuvant. Three-week-old piglets were immunized with the candidate vaccine strain, and the vaccination site was monitored daily. At six weeks of age, the pigs were challenged intravenously on two subsequent days. Daily clinical examinations were conducted, with blood and nasal swabs collected weekly throughout the study for M. hyorhinis enzyme-linked immunosorbent assay (ELISA), real-time PCR analysis, and isolation. Three weeks post-challenge, the animals were euthanized for gross and histopathological examinations. Body temperature was recorded daily, and body weight was measured upon arrival, and then at six and nine weeks of age.

Results

Vaccination significantly reduced clinical signs (p = 0.03), as well as gross pathological (p = 0.01) and histopathological (p = 0.005) lesions compared with the positive control group. The vaccinated group exhibited an earlier and higher increase in M. hyorhinis-specific IgG antibody levels post-challenge than the positive control group. However, the vaccine candidate did not mitigate the impact of M. hyorhinis infection on the weight gain. After the challenge (days 21–42), both the vaccinated (p = 0.001) and the positive control (p = 0.003) groups exhibited reduced weight gain compared with the negative control group.

Discussion

Overall, the attenuated M. hyorhinis strain, combined with the adjuvant, provided protection against M. hyorhinis infection. These results form a basis for the development of a novel vaccine candidate that offers effective prevention.
猪支原体(支原体)对猪造成了巨大的经济损失。目前,预防和治疗依赖于尽量减少风险因素和使用抗生素,因为欧洲没有商业化的疫苗。然而,抗生素往往不能完全消除细菌。有效疫苗的开发可能导致潜在的长期控制方法。材料与方法利用1-甲基-3-硝基-1-亚硝基胍(NTG)诱变技术,培养了一株温度敏感的嗜疫分枝杆菌。该疫苗候选克隆与一种佐剂联合使用,评价了其免疫原性和效力。采用候选疫苗株对3周龄仔猪进行免疫,每日监测接种部位。在6周龄时,猪在随后的两天内静脉注射。每天进行临床检查,在整个研究过程中每周采集血液和鼻拭子进行鼻咽支原体酶联免疫吸附试验(ELISA)、实时PCR分析和分离。三周后,对动物实施安乐死,进行大体和组织病理学检查。每天记录体温,出生时测量体重,然后在6和9周龄时测量体重。结果与阳性对照组相比,接种疫苗显著减少了临床症状(p = 0.03),显著减少了大体病理(p = 0.01)和组织病理(p = 0.005)病变。与阳性对照组相比,接种疫苗组在攻毒后表现出更早和更高的缩喉支原体特异性IgG抗体水平升高。然而,候选疫苗并没有减轻猪链球菌感染对体重增加的影响。攻毒后(第21-42天),与阴性对照组相比,接种疫苗组(p = 0.001)和阳性对照组(p = 0.003)的体重增加都有所减少。总之,减毒后的猪支原体与佐剂结合,对猪支原体感染提供了保护。这些结果为开发一种新型候选疫苗提供了有效预防的基础。
{"title":"Development and efficacy test of a live, attenuated Mycoplasma hyorhinis vaccine candidate strain","authors":"Eszter Zsófia Nagy ,&nbsp;Levente Szeredi ,&nbsp;Dorottya Földi ,&nbsp;Nikolett Belecz ,&nbsp;Áron Botond Kovács ,&nbsp;Kinga Mária Sulyok ,&nbsp;Dénes Grózner ,&nbsp;Enikő Wehmann ,&nbsp;Krisztián Bányai ,&nbsp;Szilvia Marton ,&nbsp;Miklós Tenk ,&nbsp;Zsuzsa Kreizinger ,&nbsp;Miklós Gyuranecz","doi":"10.1016/j.vaccine.2026.128278","DOIUrl":"10.1016/j.vaccine.2026.128278","url":null,"abstract":"<div><h3>Background</h3><div><em>Mycoplasma</em> (<em>M</em>.) <em>hyorhinis</em> causes substantial economic losses in swine. Currently, prevention and treatment rely on minimizing risk factors and administering antibiotics, as no vaccines are commercially available in Europe. However, antibiotics often cannot fully eliminate the bacteria. The development of an effective vaccine could lead to a potentially long-term control method.</div></div><div><h3>Materials and methods</h3><div>A temperature-sensitive <em>M. hyorhinis</em> strain was developed using 1-methyl-3-nitro-1-nitrosoguanidine (NTG) mutagenesis. The immunogenicity and efficacy of this vaccine candidate clone were evaluated in combination with an adjuvant. Three-week-old piglets were immunized with the candidate vaccine strain, and the vaccination site was monitored daily. At six weeks of age, the pigs were challenged intravenously on two subsequent days. Daily clinical examinations were conducted, with blood and nasal swabs collected weekly throughout the study for <em>M. hyorhinis</em> enzyme-linked immunosorbent assay (ELISA), real-time PCR analysis, and isolation. Three weeks post-challenge, the animals were euthanized for gross and histopathological examinations. Body temperature was recorded daily, and body weight was measured upon arrival, and then at six and nine weeks of age.</div></div><div><h3>Results</h3><div>Vaccination significantly reduced clinical signs (<em>p</em> = 0.03), as well as gross pathological (<em>p</em> = 0.01) and histopathological (<em>p</em> = 0.005) lesions compared with the positive control group. The vaccinated group exhibited an earlier and higher increase in <em>M. hyorhinis</em>-specific IgG antibody levels post-challenge than the positive control group. However, the vaccine candidate did not mitigate the impact of <em>M. hyorhinis</em> infection on the weight gain. After the challenge (days 21–42), both the vaccinated (<em>p</em> = 0.001) and the positive control (<em>p</em> = 0.003) groups exhibited reduced weight gain compared with the negative control group.</div></div><div><h3>Discussion</h3><div>Overall, the attenuated <em>M. hyorhinis</em> strain, combined with the adjuvant, provided protection against <em>M. hyorhinis</em> infection. These results form a basis for the development of a novel vaccine candidate that offers effective prevention.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128278"},"PeriodicalIF":4.5,"publicationDate":"2026-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146079790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Accuracy of ICD and SNOMED search strategies for adverse events following COVID-19 vaccination: Analysis of hospital administrative data COVID-19疫苗接种后不良事件的ICD和SNOMED搜索策略的准确性:医院行政数据分析
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-31 DOI: 10.1016/j.vaccine.2026.128275
Timothy Kenealy , Nelson Aguirre-Duarte , Richard H. Roxburgh , Gordon Royle , Bryan Mitchelson , Joan Ingram , Nicky Williams , Helen Petousis-Harris

Background

Hospital discharge codes can be used to identify possible Adverse Events of Special Interest (AESI) following COVID-19 vaccinations.

Aim

We sought to estimate the positive predictive value (PPV) and level of certainty of ICD-10-AM and SNOMED coding for meeting Brighton Collaboration case definitions of AESIs in Aotearoa, New Zealand.

Methods

Our expert panel identified 24 ICD-10-AM codes and 2 SNOMED codes expected to identify 9 AESIs. We sought codes likely to be specific rather than sensitive. Medical record reviews were conducted by an experienced coder, adjudicated by medical specialists, for the level of certainty that each case met the target case definition. Admissions coded to an explicit alternative diagnosis were classified as Not a Case.

Results

Our data covered over 3 million people. Reviews were conducted on 761 medical records, randomly selected from admissions principally in calendar years 2016 to 2019. We report the PPV of each code with respect to its level of certainty of meeting the case definition. Only Guillain-Barré had a single code specific to a single AESI. Several neurological conditions had overlapping codes, conditions and case definitions. PPVs for individual codes to meet case definitions ranged from 11% to 100%. Level of certainty of each code and PPV are specified.

Conclusion

PPVs of codes for each AESI need to be assessed on a case-by-case basis. Many codes are arguably insufficiently ‘accurate’ to identify a target AESI. We did not assess PPVs for combinations of codes. Our method did not allow us to estimate the number of cases missed by the coding.
背景:出院代码可用于识别COVID-19疫苗接种后可能出现的特殊关注不良事件(AESI)。目的:我们试图估计ICD-10-AM和SNOMED编码的阳性预测值(PPV)和确定性水平,以满足新西兰Aotearoa的Brighton协作病例定义。方法:我们的专家小组确定了24个ICD-10-AM代码和2个SNOMED代码,预计将识别9个aesi。我们寻找的代码可能是特定的,而不是敏感的。医疗记录审查由经验丰富的编码员进行,并由医学专家裁决,以确定每个病例符合目标病例定义的程度。编码为明确替代诊断的入院被归类为非病例。结果:我们的数据覆盖了超过300万人。对761份医疗记录进行了审查,这些记录主要是在2016年至2019年的历年期间随机选择的。我们报告每个代码的PPV相对于其满足案例定义的确定性水平。只有格林-巴里尔有一个特定于单一AESI的单一代码。几种神经系统疾病有重叠的代码、条件和病例定义。个别代码满足案例定义的ppv从11%到100%不等。规定了每个规范和PPV的确定程度。结论:每个AESI的代码ppv需要逐个评估。许多代码可能不足以“准确”识别目标AESI。我们没有评估组合代码的ppv。我们的方法不允许我们估计编码遗漏的情况的数量。
{"title":"Accuracy of ICD and SNOMED search strategies for adverse events following COVID-19 vaccination: Analysis of hospital administrative data","authors":"Timothy Kenealy ,&nbsp;Nelson Aguirre-Duarte ,&nbsp;Richard H. Roxburgh ,&nbsp;Gordon Royle ,&nbsp;Bryan Mitchelson ,&nbsp;Joan Ingram ,&nbsp;Nicky Williams ,&nbsp;Helen Petousis-Harris","doi":"10.1016/j.vaccine.2026.128275","DOIUrl":"10.1016/j.vaccine.2026.128275","url":null,"abstract":"<div><h3>Background</h3><div>Hospital discharge codes can be used to identify possible Adverse Events of Special Interest (AESI) following COVID-19 vaccinations.</div></div><div><h3>Aim</h3><div>We sought to estimate the positive predictive value (PPV) and level of certainty of ICD-10-AM and SNOMED coding for meeting Brighton Collaboration case definitions of AESIs in Aotearoa, New Zealand.</div></div><div><h3>Methods</h3><div>Our expert panel identified 24 ICD-10-AM codes and 2 SNOMED codes expected to identify 9 AESIs. We sought codes likely to be specific rather than sensitive. Medical record reviews were conducted by an experienced coder, adjudicated by medical specialists, for the level of certainty that each case met the target case definition. Admissions coded to an explicit alternative diagnosis were classified as Not a Case.</div></div><div><h3>Results</h3><div>Our data covered over 3 million people. Reviews were conducted on 761 medical records, randomly selected from admissions principally in calendar years 2016 to 2019. We report the PPV of each code with respect to its level of certainty of meeting the case definition. Only Guillain-Barré had a single code specific to a single AESI. Several neurological conditions had overlapping codes, conditions and case definitions. PPVs for individual codes to meet case definitions ranged from 11% to 100%. Level of certainty of each code and PPV are specified.</div></div><div><h3>Conclusion</h3><div>PPVs of codes for each AESI need to be assessed on a case-by-case basis. Many codes are arguably insufficiently ‘accurate’ to identify a target AESI. We did not assess PPVs for combinations of codes. Our method did not allow us to estimate the number of cases missed by the coding.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128275"},"PeriodicalIF":4.5,"publicationDate":"2026-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101278","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Understanding COVID-19 vaccination choices and development of a toolkit and training for Botswana, 2022–2023 了解2022-2023年博茨瓦纳COVID-19疫苗接种选择并制定工具包和培训
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-23 DOI: 10.1016/j.vaccine.2026.128274
Megan E. Mansfield , Lillian Okui , Selebaleng Simon , Divya Hosangadi , Milton Montebatsi , Kaizer Ikgopoleng , Lesego Kuate , Basego Mothowaeng , Nessa Ryan , Daiva Yee , Melissa Dahlke , Kristen A. Stafford , Ndwapi Ndwapi , Abia Sebaka , Stacie M. Greby

Background

In 2022, despite initial coverage data indicating good acceptance of the vaccine by eligible groups, COVID-19 vaccination coverage in Botswana was below the Ministry of Health's goal of 80%, with underlying reasons unclear. Therefore, we conducted a study to identify facilitators and barriers to COVID-19 vaccination to inform the design and implementation of a toolkit to improve COVID-19 vaccination rates.

Methods

We conducted a sequential two-phased exploratory mixed methods study: Phase 1 (toolkit development and refinement) followed by Phase 2 (toolkit implementation and evaluation). Phase 1 involved two rounds of focus group discussions (FGDs) with general population and health care providers from various regions, followed by thematic analysis. Round 1 (32 FGDs, n = 298) aimed to identify facilitators and barriers to vaccination, while Round 2 (10 FGDs, n = 86) provided feedback to refine the toolkit. Phase 2 included training across 14 districts and evaluated knowledge and competence of vaccine providers (n = 92) through electronic pre-post questionnaires and Wilcoxon Signed-Rank Tests to assess differences.

Results

Facilitators of vaccination included access to accurate and trusted information as well as realistic expectations about vaccine benefits and side effects. Barriers included misinformation, lack of access to trusted information, difficulty accessing vaccines, and concerns about side effects. The toolkit content was tailored to the local context for providers and the public. Feedback indicated the toolkit was informative and helpful, with recommendations to add information on booster doses, vaccinating adolescents, and additional visuals, while limiting referrals to external information sources. Post-training assessments showed improvements in vaccine-related knowledge (Z = 221, p < 0.001) and competence in vaccine care and counseling (Z = 22, p < 0.001). Participants showed increased knowledge (Z = 292, p < 0.01) and competence (Z = 77, p < 0.001) in motivational interviewing.

Conclusion

Engagement with general public and providers in Botswana informed the design of an evidence-based, culturally appropriate toolkit and training that effectively improved vaccine knowledge and provider competence.
2022年,尽管初步覆盖率数据表明符合条件的人群对疫苗的接受程度良好,但博茨瓦纳的COVID-19疫苗接种覆盖率仍低于卫生部80%的目标,其根本原因尚不清楚。因此,我们开展了一项研究,以确定COVID-19疫苗接种的促进因素和障碍,为设计和实施提高COVID-19疫苗接种率的工具包提供信息。方法我们进行了连续两阶段的探索性混合方法研究:第一阶段(工具包开发和改进),第二阶段(工具包实施和评估)。第一阶段涉及两轮焦点小组讨论,对象是来自不同地区的普通民众和保健提供者,随后进行专题分析。第1轮(32个fgd, n = 298)旨在确定疫苗接种的促进因素和障碍,而第2轮(10个fgd, n = 86)提供反馈以完善工具包。第二阶段包括在14个地区进行培训,并通过电子事后问卷和Wilcoxon签名秩检验评估疫苗提供者的知识和能力(n = 92)。结果疫苗接种的促进因素包括获得准确和可信的信息以及对疫苗益处和副作用的现实期望。障碍包括错误信息、无法获得可信信息、难以获得疫苗以及对副作用的担忧。工具包内容针对提供者和公众的本地环境进行了定制。反馈表明,该工具包内容丰富、有益,并建议增加关于加强剂量、青少年接种疫苗的信息和额外的视觉效果,同时限制转诊到外部信息来源。培训后评估显示疫苗相关知识(Z = 221, p < 0.001)和疫苗护理和咨询能力(Z = 22, p < 0.001)有所改善。参与者在动机访谈中表现出知识(Z = 292, p < 0.01)和能力(Z = 77, p < 0.001)的提高。结论博茨瓦纳与公众和提供者的接触为设计循证、文化上适当的工具包和培训提供了信息,有效地提高了疫苗知识和提供者能力。
{"title":"Understanding COVID-19 vaccination choices and development of a toolkit and training for Botswana, 2022–2023","authors":"Megan E. Mansfield ,&nbsp;Lillian Okui ,&nbsp;Selebaleng Simon ,&nbsp;Divya Hosangadi ,&nbsp;Milton Montebatsi ,&nbsp;Kaizer Ikgopoleng ,&nbsp;Lesego Kuate ,&nbsp;Basego Mothowaeng ,&nbsp;Nessa Ryan ,&nbsp;Daiva Yee ,&nbsp;Melissa Dahlke ,&nbsp;Kristen A. Stafford ,&nbsp;Ndwapi Ndwapi ,&nbsp;Abia Sebaka ,&nbsp;Stacie M. Greby","doi":"10.1016/j.vaccine.2026.128274","DOIUrl":"10.1016/j.vaccine.2026.128274","url":null,"abstract":"<div><h3>Background</h3><div>In 2022, despite initial coverage data indicating good acceptance of the vaccine by eligible groups, COVID-19 vaccination coverage in Botswana was below the Ministry of Health's goal of 80%, with underlying reasons unclear. Therefore, we conducted a study to identify facilitators and barriers to COVID-19 vaccination to inform the design and implementation of a toolkit to improve COVID-19 vaccination rates.</div></div><div><h3>Methods</h3><div>We conducted a sequential two-phased exploratory mixed methods study: Phase 1 (toolkit development and refinement) followed by Phase 2 (toolkit implementation and evaluation). Phase 1 involved two rounds of focus group discussions (FGDs) with general population and health care providers from various regions, followed by thematic analysis. Round 1 (32 FGDs, <em>n</em> = 298) aimed to identify facilitators and barriers to vaccination, while Round 2 (10 FGDs, <em>n</em> = 86) provided feedback to refine the toolkit. Phase 2 included training across 14 districts and evaluated knowledge and competence of vaccine providers (<em>n</em> = 92) through electronic pre-post questionnaires and Wilcoxon Signed-Rank Tests to assess differences.</div></div><div><h3>Results</h3><div>Facilitators of vaccination included access to accurate and trusted information as well as realistic expectations about vaccine benefits and side effects. Barriers included misinformation, lack of access to trusted information, difficulty accessing vaccines, and concerns about side effects. The toolkit content was tailored to the local context for providers and the public. Feedback indicated the toolkit was informative and helpful, with recommendations to add information on booster doses, vaccinating adolescents, and additional visuals, while limiting referrals to external information sources. Post-training assessments showed improvements in vaccine-related knowledge (Z = 221, <em>p</em> &lt; 0.001) and competence in vaccine care and counseling (Z = 22, <em>p</em> &lt; 0.001). Participants showed increased knowledge (Z = 292, <em>p</em> &lt; 0.01) and competence (Z = 77, p &lt; 0.001) in motivational interviewing.</div></div><div><h3>Conclusion</h3><div>Engagement with general public and providers in Botswana informed the design of an evidence-based, culturally appropriate toolkit and training that effectively improved vaccine knowledge and provider competence.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128274"},"PeriodicalIF":4.5,"publicationDate":"2026-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146039537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Fathers' reports of within-household vaccine decision making and young children's COVID-19 vaccination status 父亲报告家庭内疫苗接种决策和幼儿COVID-19疫苗接种状况。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-31 DOI: 10.1016/j.vaccine.2026.128282
In Young Park , Alejandra Cantu-Aldana , Natalie Grafft , Brian K. Lo , Katherine W. Bauer , Brent A. McBride , Sebastien J. Haneuse , Jess Haines , Kirsten K. Davison
Understanding how parents make decisions about child vaccination is important to guide interventions to increase child vaccination rates. However, few studies have examined parent vaccine decision making within households and no studies have examined this question from the perspective of fathers. In a sample of 943 fathers, from the Fathers & Families cohort and living in two-parent (father-mother) households, this study examines parents' decision making and agreement about their child receiving, or not receiving, the COVID-19 vaccine, and links with children's vaccination status. The association between fathers' and mothers' agreement about whether or not to vaccinate child against COVID-19 and child COVID-19 vaccination status was examined using multivariate logistic regression, adjusting for parent characteristics. The vast majority of fathers (89.0%) reported that they and their child's mother jointly decided on vaccinating their child and typically agreed on whether or not to vaccinate their child against COVID-19. Multivariate logistic analysis showed that children whose parents agreed on whether or not to vaccinate them were 14.8 times (B = 2.70, 95% CI: 7.1–31.2) more likely to have received the COVID-19 vaccine than those whose parents disagreed or had not discussed vaccination. The findings highlight a new avenue for outreach efforts aimed at promoting child vaccination rates through understanding fathers' specific concerns about child vaccines and communication with fathers and mothers about child vaccination.
了解父母如何对儿童疫苗接种做出决定,对于指导提高儿童疫苗接种率的干预措施非常重要。然而,很少有研究审查家庭内父母的疫苗决策,也没有研究从父亲的角度审查这个问题。在来自父亲与家庭队列并生活在双亲(父亲-母亲)家庭的943名父亲的样本中,本研究考察了父母对孩子接种或不接种COVID-19疫苗的决策和同意,以及与儿童接种疫苗状况的联系。采用多变量logistic回归,调整父母特征,检验父亲和母亲同意是否为儿童接种COVID-19疫苗与儿童COVID-19疫苗接种状况之间的关系。绝大多数父亲(89.0%)报告说,他们和孩子的母亲共同决定为孩子接种疫苗,并通常就是否为孩子接种COVID-19疫苗达成一致。多因素logistic分析显示,父母同意是否接种疫苗的儿童接种COVID-19疫苗的可能性是父母不同意或未讨论接种疫苗的儿童的14.8倍(B = 2.70, 95% CI: 7.1-31.2)。研究结果强调了通过了解父亲对儿童疫苗的具体关切以及与父亲和母亲就儿童疫苗接种进行沟通来提高儿童疫苗接种率的新途径。
{"title":"Fathers' reports of within-household vaccine decision making and young children's COVID-19 vaccination status","authors":"In Young Park ,&nbsp;Alejandra Cantu-Aldana ,&nbsp;Natalie Grafft ,&nbsp;Brian K. Lo ,&nbsp;Katherine W. Bauer ,&nbsp;Brent A. McBride ,&nbsp;Sebastien J. Haneuse ,&nbsp;Jess Haines ,&nbsp;Kirsten K. Davison","doi":"10.1016/j.vaccine.2026.128282","DOIUrl":"10.1016/j.vaccine.2026.128282","url":null,"abstract":"<div><div>Understanding how parents make decisions about child vaccination is important to guide interventions to increase child vaccination rates. However, few studies have examined parent vaccine decision making within households and no studies have examined this question from the perspective of fathers. In a sample of 943 fathers, from the <em>Fathers &amp; Families</em> cohort and living in two-parent (father-mother) households, this study examines parents' decision making and agreement about their child receiving, or not receiving, the COVID-19 vaccine, and links with children's vaccination status. The association between fathers' and mothers' agreement about whether or not to vaccinate child against COVID-19 and child COVID-19 vaccination status was examined using multivariate logistic regression, adjusting for parent characteristics. The vast majority of fathers (89.0%) reported that they and their child's mother jointly decided on vaccinating their child and typically agreed on whether or not to vaccinate their child against COVID-19. Multivariate logistic analysis showed that children whose parents agreed on whether or not to vaccinate them were 14.8 times (B = 2.70, 95% CI: 7.1–31.2) more likely to have received the COVID-19 vaccine than those whose parents disagreed or had not discussed vaccination. The findings highlight a new avenue for outreach efforts aimed at promoting child vaccination rates through understanding fathers' specific concerns about child vaccines and communication with fathers and mothers about child vaccination.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128282"},"PeriodicalIF":4.5,"publicationDate":"2026-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
SARS-CoV-2 T-cell vaccine VB10.2210 induces broad T-cell responses in a phase 1/2 open-label clinical trial sars - cov - 2t细胞疫苗VB10.2210在1/2期开放标签临床试验中诱导广泛的t细胞反应
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-02-01 DOI: 10.1016/j.vaccine.2026.128290
Camilla Tøndel , Synne Jenum , Kristian Tonby , Erik Egeland Christensen , Rebecca Jane Cox , Therese Bredholt Onyango , Linda Gail Skeie , Harlan Robins , Mark Klinger , Barb Banbury , Thomas Bello , Edward J. Osborne , Marthe Jøntvedt Jørgensen , Stephane Pourpe , Ingvild Sørum Leikfoss , Thomas Jürgens , Hedda Wold , Siri Torhaug , Shokouh Makvandi-Nejad , Diana Edo-Matas , Anne Ma Dyrhol-Riise
The repeated emergence of highly transmissive SARS-CoV-2 variants requires a broadly protective vaccine. We developed a T-cell vaccine VB10.2210 that targets SARS-CoV-2 viral antigens to antigen presenting cells comprising 96 validated immunogenic T-cell epitopes covering a global HLA diversity. We report results from a first in human open-label dose-escalation phase 1/2 clinical trial evaluating safety, reactogenicity and immunogenicity of VB10.2210. The study investigated three dose levels (0.3, 1.0 and 3.0 mg), delivered intramuscularly as DNA plasmid by jet injection (NCT05069623), in 34 healthy adults previously vaccinated with mRNA SARS-CoV-2 vaccines. The safety profile was favorable with no observed dose-limiting toxicity. The 3 mg dose elicited the most potent immune response with enhanced breadth and a CD8+ dominated T cell response. T cell responses towards spike protein and de novo responses to non-spike antigens were confirmed by ELISpot. Expansion of VB10.2210 specific T-cell clones was confirmed by TCR sequencing. Further studies are needed to evaluate the clinical benefit of DNA vaccines inducing broad virus specific T-cell immunity in preventing severe COVID-19 or as treatment of patients with persistent infection.
高传染性SARS-CoV-2变体的反复出现需要一种具有广泛保护性的疫苗。我们开发了一种t细胞疫苗VB10.2210,它将SARS-CoV-2病毒抗原靶向抗原提呈细胞,包括96个经过验证的覆盖全球HLA多样性的免疫原性t细胞表位。我们报告了一项首次人类开放标签剂量递增1/2期临床试验的结果,该试验评估了VB10.2210的安全性、反应性和免疫原性。该研究对34名先前接种过mRNA SARS-CoV-2疫苗的健康成年人进行了三种剂量水平(0.3、1.0和3.0 mg)的研究,以DNA质粒的形式通过喷射注射(NCT05069623)肌肉注射。安全性良好,没有观察到剂量限制性毒性。3mg剂量引起了最有效的免疫反应,具有增强的广度和CD8+主导的T细胞反应。通过ELISpot验证T细胞对刺突蛋白的应答和对非刺突抗原的新生应答。通过TCR测序证实了VB10.2210特异性t细胞克隆的扩增。DNA疫苗诱导广泛病毒特异性t细胞免疫在预防重症COVID-19或治疗持续性感染患者方面的临床效益有待进一步研究。
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引用次数: 0
Immunological response of using emulsifying elongation factor 1 alpha of Plasmodium falciparum-based vaccines in complete Freund's adjuvant 在完全弗氏佐剂中使用恶性疟原虫基础疫苗乳化延伸因子1 α的免疫应答
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-29 DOI: 10.1016/j.vaccine.2026.128279
Hyelee Hong , Tae-Hui Eom , Eun Lee , Eunho Lee , Hyun-Young Lee , Solchan Won , Dong-Sup Lee , Mi-il Kim , Hyun Park , Seon-Ju Yeo
Most studies of malarial vaccines focused on increasing immunity against target molecules on the surface of Plasmodium spp. parasites. While the surface antigens are variable among all Plasmodium spp., intracellular antigens are highly conserved, and thus, intracellular targets must be studied as vaccine candidates. However, there is a scarcity of intracellular vaccine candidates in Plasmodium parasites. In this study, immune responses induced by complete Freund's Adjuvant (CFA) emulsified with an elongation factor-1 alpha of P. falciparum (PfEF-1α) was analyzed as a Plasmodium spp. conserved vaccine candidate. In vivo vaccine efficacy, antibody production, and ex vivo T-cell cytokine assays were analyzed to validate the potential of PfEF-1α at CFA-based formulation in a rodent model. Immunoinformatics was employed to predict potential vaccine epitope candidates, and a novel peptide candidate was validated by ex vivo T-cell study. The survival rate of the rPfEF-1α plus CFA-immunized group was increased by 50% and among the survived mice, half proportion of mice was not patent at all while all BSA plus CFA showed the patency. Upon co-culturing of T cells with dendritic cells, PfEF-1α-specific ex vivo T-cell assay revealed CD4+IFN-γ+ secretion as the dominant immune response, followed by CD8+IFN-γ+ and CD4+IL-4+ subsets. Immunization with rPfEF-1-α plus CFA elicited robust humoral immunity, demonstrating a 16-fold higher antigen-specific IgG endpoint titer compared to the BSA plus CFA-immunized group. IgG1 and IgG2c titers in rPfEF-1α plus CFA-immunized mice were highly elevated over BSA plus CFA-immunized group. Furthermore, the PfEF-1α epitope (410-FAIRDMRQTI-419), identified through in silico prediction and validated, induced IFN-γ secretion in ex vivo C57BL/6 T-cell study. These results demonstrate PfEF-1α's capacity to drive protective T-cell responses and antibody production with CFA adjuvant. Our findings suggest the use of intracellular antigen for development of malaria vaccine targets.
大多数疟疾疫苗的研究都集中在增强对疟原虫表面靶分子的免疫力上。虽然表面抗原在所有疟原虫中都是可变的,但细胞内抗原是高度保守的,因此必须研究细胞内靶点作为候选疫苗。然而,疟原虫的细胞内候选疫苗缺乏。本研究分析了恶性疟原虫延伸因子-1α (PfEF-1α)乳化的完全弗氏佐剂(CFA)作为疟原虫保守候选疫苗诱导的免疫应答。我们分析了体内疫苗效力、抗体产生和体外t细胞细胞因子测定,以验证PfEF-1α在啮齿动物模型中以cfa为基础配方的潜力。利用免疫信息学预测潜在的疫苗候选表位,并通过体外t细胞研究验证了一种新的候选肽。rPfEF-1α + CFA免疫组的存活率提高了50%,存活小鼠中有一半的小鼠完全不通畅,而BSA + CFA免疫组的小鼠全部通畅。在T细胞与树突状细胞共培养后,pfef -1α特异性体外T细胞检测显示CD4+IFN-γ+分泌是主要的免疫反应,其次是CD8+IFN-γ+和CD4+IL-4+亚群。与BSA + CFA免疫组相比,rPfEF-1-α + CFA免疫组可引起强大的体液免疫,显示抗原特异性IgG终点滴度高16倍。rfef -1α + cfa免疫小鼠IgG1和IgG2c滴度较BSA + cfa免疫组显著升高。此外,通过计算机预测鉴定并验证的PfEF-1α表位(410-FAIRDMRQTI-419)在体外C57BL/6 t细胞研究中诱导IFN-γ分泌。这些结果表明PfEF-1α具有驱动保护性t细胞反应和CFA佐剂抗体产生的能力。我们的发现提示使用细胞内抗原开发疟疾疫苗靶点。
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Vaccine
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