Pub Date : 2025-01-25Epub Date: 2024-12-12DOI: 10.1016/j.vaccine.2024.126586
Stefan Slamanig, Nicholas Lemus, Tsoi Ying Lai, Gagandeep Singh, Mitali Mishra, Adam Abdeljawad, Marta Boza, Victoria Dolange, Gagandeep Singh, Benhur Lee, Irene González-Domínguez, Michael Schotsaert, Florian Krammer, Peter Palese, Weina Sun
The rapid development of coronavirus disease 2019 (COVID-19) vaccines has helped mitigate the initial impact of the pandemic. However, in order to reduce transmission rates and protect more vulnerable and immunocompromised individuals unable to mount an effective immune response, development of a next-generation of mucosal vaccines is necessary. Here, we developed an intranasal Newcastle disease virus (NDV)-based vaccine expressing the spike of the XBB.1.5 variant stabilized in its pre-fusion conformation (NDV-HXP-S). We demonstrated that one or two intranasal immunizations with live NDV-HXP-S expressing the XBB.1.5 spike induces systemic and mucosal antibody responses in mice and protects them from a challenge with the XBB.1.5 variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Furthermore, one or two intranasal vaccinations with NDV-HXP-S XBB.1.5 protected hamsters from variant matched infection and reduced virus emission, thereby providing complete protection to naïve animals in a direct contact transmission study. The data shown in this study supports the notion that intranasal vaccination with variant-adapted NDV-HXP-S induces protective mucosal immunity and reduces transmission rates, highlighting the robust protective efficacy of a single mucosal vaccination in mice and hamsters.
2019冠状病毒病(COVID-19)疫苗的快速开发有助于减轻大流行的初步影响。然而,为了降低传播率和保护更脆弱和免疫功能低下的个体,无法进行有效的免疫应答,开发下一代粘膜疫苗是必要的。在这里,我们开发了一种基于鼻内新城疫病毒(NDV)的疫苗,该疫苗表达了稳定在融合前构象(NDV- hxp - s)的XBB.1.5变异体的spike。我们证明,用表达XBB.1.5刺突的活NDV-HXP-S进行一次或两次鼻内免疫可诱导小鼠全身和粘膜抗体反应,并保护它们免受XBB.1.5变体严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)的攻击。此外,一次或两次鼻内接种ndv - hps - s XBB.1.5可保护仓鼠免受变异匹配感染并减少病毒排放,从而为直接接触传播研究中的naïve动物提供完全保护。本研究显示的数据支持这样一种观点,即鼻内接种变异适应的NDV-HXP-S疫苗可诱导保护性粘膜免疫并降低传播率,突出了单次粘膜疫苗对小鼠和仓鼠的强大保护作用。
{"title":"A single immunization with intranasal Newcastle disease virus (NDV)-based XBB.1.5 variant vaccine reduces disease and transmission in animals against matched-variant challenge.","authors":"Stefan Slamanig, Nicholas Lemus, Tsoi Ying Lai, Gagandeep Singh, Mitali Mishra, Adam Abdeljawad, Marta Boza, Victoria Dolange, Gagandeep Singh, Benhur Lee, Irene González-Domínguez, Michael Schotsaert, Florian Krammer, Peter Palese, Weina Sun","doi":"10.1016/j.vaccine.2024.126586","DOIUrl":"10.1016/j.vaccine.2024.126586","url":null,"abstract":"<p><p>The rapid development of coronavirus disease 2019 (COVID-19) vaccines has helped mitigate the initial impact of the pandemic. However, in order to reduce transmission rates and protect more vulnerable and immunocompromised individuals unable to mount an effective immune response, development of a next-generation of mucosal vaccines is necessary. Here, we developed an intranasal Newcastle disease virus (NDV)-based vaccine expressing the spike of the XBB.1.5 variant stabilized in its pre-fusion conformation (NDV-HXP-S). We demonstrated that one or two intranasal immunizations with live NDV-HXP-S expressing the XBB.1.5 spike induces systemic and mucosal antibody responses in mice and protects them from a challenge with the XBB.1.5 variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Furthermore, one or two intranasal vaccinations with NDV-HXP-S XBB.1.5 protected hamsters from variant matched infection and reduced virus emission, thereby providing complete protection to naïve animals in a direct contact transmission study. The data shown in this study supports the notion that intranasal vaccination with variant-adapted NDV-HXP-S induces protective mucosal immunity and reduces transmission rates, highlighting the robust protective efficacy of a single mucosal vaccination in mice and hamsters.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"45 ","pages":"126586"},"PeriodicalIF":0.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142820439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Germany primarily relies on a practice-based, opportunistic immunisation system. Despite the introduction of the Human papillomavirus (HPV) vaccine into the German vaccination schedule in 2007, coverage remains low. International experience suggests that school-based vaccination can increase HPV coverage. Therefore, in 2013/14 Bremen's public health department offered HPV vaccinations within a school programme, targeting all 8th-graders. We aimed to evaluate the programme, with a focus on vulnerable groups. In a retrospective cohort design, we analysed vaccination status and uptake among all 8th-graders from 2015/16 to 2018/19 (girls) and 2022/23 (girls and boys). Sub-analyses were based on the School Social Index (SSI), which ranges from 1 (higher socio-economic position, SEP) to 5 (lower SEP), considering factors like poverty, migration, and living environment. The study included 13,550 students from 1,440 classes in 56 schools. Among previously unvaccinated students, 26-35 % of girls and 39 % of boys annually accepted and received the school-based HPV vaccination. Uptake was higher among students from lower as compared to higher SEP schools (SSI 5: 37 % vs. SSI 1: 30 %, p = 0.022). Vaccine uptake among unvaccinated students remained stable over time, with one-third receiving at least one HPV vaccination at school. The remaining two-thirds of unvaccinated did not make use of the vaccination offer at school. It needs to be investigated if this is possibly due to vaccine hesitancy or a preference for practice-based vaccinations. While school vaccination programmes can improve uptake, implementing a nationwide programme in Germany will be challenging and may not address all existing major uptake barriers.
德国主要依靠基于实践的机会性免疫系统。尽管2007年将人乳头瘤病毒(HPV)疫苗纳入德国疫苗接种计划,但覆盖率仍然很低。国际经验表明,以学校为基础的疫苗接种可以提高HPV的覆盖率。因此,在2013/14年度,不来梅公共卫生部门在一个学校项目中为所有8年级学生提供了HPV疫苗接种。我们的目标是评估该项目,重点关注弱势群体。在回顾性队列设计中,我们分析了2015/16至2018/19年(女孩)和2022/23年(女孩和男孩)所有8年级学生的疫苗接种状况和接种率。分项分析以学校社会指数(SSI)为基础,考虑到贫困、移民、生活环境等因素,从1(较高的社会经济地位,SEP)到5(较低的SEP)。这项研究包括56所学校1440个班级的13550名学生。在以前未接种疫苗的学生中,26%至35%的女孩和39%的男孩每年接受并接受了以学校为基础的HPV疫苗接种。与高SEP学校相比,低SEP学校的学生摄取更高(SSI 5:37 % vs. SSI 1:30 %, p = 0.022)。随着时间的推移,未接种疫苗的学生的疫苗接种率保持稳定,三分之一的学生在学校至少接种了一次HPV疫苗。其余三分之二未接种疫苗的人没有利用学校提供的疫苗接种。需要调查这是否可能是由于疫苗犹豫或偏好基于实践的疫苗接种。虽然学校疫苗接种规划可以提高接种率,但在德国实施一项全国性规划将具有挑战性,可能无法解决所有现有的主要接种障碍。
{"title":"School vaccination programmes to increase HPV vaccination coverage - Experiences from Bremen, Germany.","authors":"Regina Singer, Imke Hübotter, Franziska Hölzner, Christine Genedl, Lutz Jasker, Niels Michalski, Christiane Piepel, Thorsten Rieck, Günter Tempel, Ole Wichmann, Anja Takla","doi":"10.1016/j.vaccine.2024.126636","DOIUrl":"10.1016/j.vaccine.2024.126636","url":null,"abstract":"<p><p>Germany primarily relies on a practice-based, opportunistic immunisation system. Despite the introduction of the Human papillomavirus (HPV) vaccine into the German vaccination schedule in 2007, coverage remains low. International experience suggests that school-based vaccination can increase HPV coverage. Therefore, in 2013/14 Bremen's public health department offered HPV vaccinations within a school programme, targeting all 8th-graders. We aimed to evaluate the programme, with a focus on vulnerable groups. In a retrospective cohort design, we analysed vaccination status and uptake among all 8th-graders from 2015/16 to 2018/19 (girls) and 2022/23 (girls and boys). Sub-analyses were based on the School Social Index (SSI), which ranges from 1 (higher socio-economic position, SEP) to 5 (lower SEP), considering factors like poverty, migration, and living environment. The study included 13,550 students from 1,440 classes in 56 schools. Among previously unvaccinated students, 26-35 % of girls and 39 % of boys annually accepted and received the school-based HPV vaccination. Uptake was higher among students from lower as compared to higher SEP schools (SSI 5: 37 % vs. SSI 1: 30 %, p = 0.022). Vaccine uptake among unvaccinated students remained stable over time, with one-third receiving at least one HPV vaccination at school. The remaining two-thirds of unvaccinated did not make use of the vaccination offer at school. It needs to be investigated if this is possibly due to vaccine hesitancy or a preference for practice-based vaccinations. While school vaccination programmes can improve uptake, implementing a nationwide programme in Germany will be challenging and may not address all existing major uptake barriers.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"45 ","pages":"126636"},"PeriodicalIF":0.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142866953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-25Epub Date: 2024-12-19DOI: 10.1016/j.vaccine.2024.126568
Tasmiah Nuzhath, Yingwei Yang, Marie-Claude Couture, Ning Yan Gu, Jeannette L Comeau, Annette K Regan
Introduction: Acceptance of recommended vaccines is lower among pregnant people compared to non-pregnant adults, yet no tool has specifically measured prenatal vaccine hesitancy. We evaluated the performance of an existing adult Vaccine Hesitancy Scale (aVHS) in measuring vaccine hesitancy toward routinely recommended prenatal vaccines.
Methods: Between December 2021 and April 2022, we conducted a cross-sectional national online survey with 917 US postpartum adults 18-49 years old who had given birth in the past six months. Vaccine hesitancy was measured using the aVHS, a 10-item scale previously validated among the adult general population. Scores range from 10 to 50, with higher scores indicating greater vaccine hesitancy. Structural equation modeling (SEM) with weighted least squares means and variances adjusted (WLSMV) estimator was used to assess the fit of the aVHS structure. Construct validity was assessed by examining the correlation between the aVHS score and the self-reported receipt of recommended prenatal vaccines.
Results: SEM indicated acceptable fit (RMSEA: 0.098; CFI: 0.983; TLI: 0.978; SRMR: 0.040) of the data to the two-factor model: (1) lack of vaccine confidence, and (2) perceived vaccine risks. For the paths from the two factors to the vaccine acceptance, lack of vaccine confidence was significantly correlated with influenza vaccine acceptance (β = -0.41, p < 0.001) and COVID-19 vaccine acceptance (β = -0.64, p < 0.001), while perceived vaccine risk was significantly linked with Tdap vaccine acceptance (β = -0.57, p < 0.001) and influenza vaccine acceptance (β = -0.25, p < 0.001). Additionally, pregnant people with higher aVHS scores were less likely to receive recommended prenatal vaccines.
Discussion: Although the aVHS offered acceptable measurement of prenatal vaccine hesitancy, a scale that measures pregnancy-specific concerns may offer more tailored measurement for this unique population.
{"title":"Structural equation modeling to evaluate the adult vaccine hesitancy scale for vaccines recommended during pregnancy.","authors":"Tasmiah Nuzhath, Yingwei Yang, Marie-Claude Couture, Ning Yan Gu, Jeannette L Comeau, Annette K Regan","doi":"10.1016/j.vaccine.2024.126568","DOIUrl":"10.1016/j.vaccine.2024.126568","url":null,"abstract":"<p><strong>Introduction: </strong>Acceptance of recommended vaccines is lower among pregnant people compared to non-pregnant adults, yet no tool has specifically measured prenatal vaccine hesitancy. We evaluated the performance of an existing adult Vaccine Hesitancy Scale (aVHS) in measuring vaccine hesitancy toward routinely recommended prenatal vaccines.</p><p><strong>Methods: </strong>Between December 2021 and April 2022, we conducted a cross-sectional national online survey with 917 US postpartum adults 18-49 years old who had given birth in the past six months. Vaccine hesitancy was measured using the aVHS, a 10-item scale previously validated among the adult general population. Scores range from 10 to 50, with higher scores indicating greater vaccine hesitancy. Structural equation modeling (SEM) with weighted least squares means and variances adjusted (WLSMV) estimator was used to assess the fit of the aVHS structure. Construct validity was assessed by examining the correlation between the aVHS score and the self-reported receipt of recommended prenatal vaccines.</p><p><strong>Results: </strong>SEM indicated acceptable fit (RMSEA: 0.098; CFI: 0.983; TLI: 0.978; SRMR: 0.040) of the data to the two-factor model: (1) lack of vaccine confidence, and (2) perceived vaccine risks. For the paths from the two factors to the vaccine acceptance, lack of vaccine confidence was significantly correlated with influenza vaccine acceptance (β = -0.41, p < 0.001) and COVID-19 vaccine acceptance (β = -0.64, p < 0.001), while perceived vaccine risk was significantly linked with Tdap vaccine acceptance (β = -0.57, p < 0.001) and influenza vaccine acceptance (β = -0.25, p < 0.001). Additionally, pregnant people with higher aVHS scores were less likely to receive recommended prenatal vaccines.</p><p><strong>Discussion: </strong>Although the aVHS offered acceptable measurement of prenatal vaccine hesitancy, a scale that measures pregnancy-specific concerns may offer more tailored measurement for this unique population.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"45 ","pages":"126568"},"PeriodicalIF":0.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-25Epub Date: 2024-12-20DOI: 10.1016/j.vaccine.2024.126630
Laís Albuquerque de Oliveira, Isa Rita Brito de Morais, Silvana Beutinger Marchioro, Gabriel Barroso de Almeida, Gleyce Hellen de Almeida de Souza, Tiago da Silva Ferreira, Regina Rossoni, Dyjaene de Oliveira Barbosa, Vinicius João Navarini, Julio Croda, Alex José Leite Torres, Simone Simionatto
{"title":"Corrigendum to Assessment of the Bnt162b2 covid-19 vaccine immune response in Brazilian indigenous adolescents. Vaccine Volume 43, Part 1, 1 January 2025, 126494.","authors":"Laís Albuquerque de Oliveira, Isa Rita Brito de Morais, Silvana Beutinger Marchioro, Gabriel Barroso de Almeida, Gleyce Hellen de Almeida de Souza, Tiago da Silva Ferreira, Regina Rossoni, Dyjaene de Oliveira Barbosa, Vinicius João Navarini, Julio Croda, Alex José Leite Torres, Simone Simionatto","doi":"10.1016/j.vaccine.2024.126630","DOIUrl":"10.1016/j.vaccine.2024.126630","url":null,"abstract":"","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"45 ","pages":"126630"},"PeriodicalIF":0.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: The safety of the COVID-19 inactivated vaccine on pregnancy outcomes in couples undergoing assisted reproductive technology remains uncertain due to limited and speculative evidence. Existing studies primarily focus on the vaccination status of females, with scant information available regarding the vaccination status of male partners. Moreover, there is minimal research tracking live birth outcomes.
Objective(s): The objective of this study was to evaluate the impact of COVID-19 inactivated vaccine administration on the outcomes of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles in infertile couples in China.
Methods: This prospective cohort study involved couples undergoing IVF treatment at Sichuan Jinxin Xinan Women & Children's Hospital from August 2021 to September 2022. Based on whether they received vaccination before ovarian stimulation, the couples were divided into the vaccination group and the non-vaccination group. We compared the laboratory parameters and pregnancy outcomes between the two groups.
Results: After performing propensity score matching (PSM), we observed similar live birth rates (41.23% vs. 44.08%, P = 0.555), clinical pregnancy rates (52.61% vs. 54.98%, P = 0.625), biochemical pregnancy (62.56% vs. 63.98%, P = 0.762), and ongoing pregnancy rates (49.76% vs. 51.18%, P = 0.770) between the vaccinated and unvaccinated women. Also, no significant disparities were found in terms of embryo development and laboratory parameters between the groups. Moreover, male vaccination had no impact on patients' pregnancy outcomes in assisted reproductive technology (ART) treatments (all P > 0.05). Additionally, there were no observable effects of vaccination on embryo development and pregnancy outcomes among couples undergoing ART (all P > 0.05).
Conclusion(s): The findings suggest that COVID-19 vaccination did not have a significant effect on patients undergoing IVF/ICSI with fresh embryo transfer. Therefore, it is recommended that couples should receive COVID-19 vaccination as scheduled to help mitigate the COVID-19 pandemic.
{"title":"The Safety and Efficacy of inactivated COVID-19 vaccination in couples undergoing assisted reproductive technology: A prospective cohort study.","authors":"Juan Yang, Ying-Ling Yao, Xing-Yu Lv, Li-Hong Geng, Yue Wang, Enoch Appiah Adu-Gyamfi, Xue-Jiao Wang, Yue Qian, Ming-Xing Chen, Zhao-Hui Zhong, Ren-Yan Li, Qi Wan, Yu-Bin Ding","doi":"10.1016/j.vaccine.2024.126635","DOIUrl":"10.1016/j.vaccine.2024.126635","url":null,"abstract":"<p><strong>Background: </strong>The safety of the COVID-19 inactivated vaccine on pregnancy outcomes in couples undergoing assisted reproductive technology remains uncertain due to limited and speculative evidence. Existing studies primarily focus on the vaccination status of females, with scant information available regarding the vaccination status of male partners. Moreover, there is minimal research tracking live birth outcomes.</p><p><strong>Objective(s): </strong>The objective of this study was to evaluate the impact of COVID-19 inactivated vaccine administration on the outcomes of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles in infertile couples in China.</p><p><strong>Methods: </strong>This prospective cohort study involved couples undergoing IVF treatment at Sichuan Jinxin Xinan Women & Children's Hospital from August 2021 to September 2022. Based on whether they received vaccination before ovarian stimulation, the couples were divided into the vaccination group and the non-vaccination group. We compared the laboratory parameters and pregnancy outcomes between the two groups.</p><p><strong>Results: </strong>After performing propensity score matching (PSM), we observed similar live birth rates (41.23% vs. 44.08%, P = 0.555), clinical pregnancy rates (52.61% vs. 54.98%, P = 0.625), biochemical pregnancy (62.56% vs. 63.98%, P = 0.762), and ongoing pregnancy rates (49.76% vs. 51.18%, P = 0.770) between the vaccinated and unvaccinated women. Also, no significant disparities were found in terms of embryo development and laboratory parameters between the groups. Moreover, male vaccination had no impact on patients' pregnancy outcomes in assisted reproductive technology (ART) treatments (all P > 0.05). Additionally, there were no observable effects of vaccination on embryo development and pregnancy outcomes among couples undergoing ART (all P > 0.05).</p><p><strong>Conclusion(s): </strong>The findings suggest that COVID-19 vaccination did not have a significant effect on patients undergoing IVF/ICSI with fresh embryo transfer. Therefore, it is recommended that couples should receive COVID-19 vaccination as scheduled to help mitigate the COVID-19 pandemic.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"45 ","pages":"126635"},"PeriodicalIF":0.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-25Epub Date: 2024-12-24DOI: 10.1016/j.vaccine.2024.126647
Yonas Gebrecherkos, David Hodgson
Background: Respiratory Syncytial Virus (RSV) is a common cause of hospitalisation in infants worldwide, causing significant morbidity and mortality. Recently, the antiviral treatment, Ziresovir, has shown promising results in a Phase III trial conducted on infants hospitalised with RSV. Based on these topline results, this study aims to investigate the cost-effectiveness of Ziresovir in the United Kingdom (UK).
Methods: The cost-effective analysis (CEA) uses a proportional outcomes model using data from topline reports by the AIRFLO trial and published data to explore the effect of Ziresovir administration on hospitalised infants aged <24 months at admission. We estimated the reduction in ICU bed days and deaths and the maximum cost-effective price (MCEP) per treated individual, assuming a threshold of £20,000 per Quality-adjusted Life Year (QALY) gained.
Results: Administering Ziresovir to all hospitalised infants averts four deaths (range: 2.8-4.5), 216 ICU admissions (range:160-260) and 3169 ICU bed-days (range: 2348-3804) per annum, the MCEP for Ziresovir per hospitalised infant is £429.65 (95 % CrI: £236-£771). If preterm infants are targeted, then the MCEP increases to £2108.38 (95 % Crl: £870-£3540). The MCEP for exclusively treating Infants with Chronic Lung Disease (CLD) and Congenital Heart Disease (CHD) is £6557.24 (95 % Crl: £1250 - £14,920) and £9459.44 (95 % Crl £3350-£20,300) respectively. The model is highly sensitive to changes in the efficacy of Ziresovir and the risk of ICU admission and mortality.
Conclusion: Ziresovir is a cost-effective intervention for all infants hospitalised with RSV if priced below £430 per dose and strategies that exclusively treat high-risk- with CLD and CHD infants justify a higher price of £6558 and £9460 respectively. The outcomes are highly sensitive to the efficacy of Ziresovir and can be improved when the full results of the AIRFLO trial are available.
{"title":"Cost-effectiveness of anti-viral treatment for infants with RSV disease in the United Kingdom.","authors":"Yonas Gebrecherkos, David Hodgson","doi":"10.1016/j.vaccine.2024.126647","DOIUrl":"10.1016/j.vaccine.2024.126647","url":null,"abstract":"<p><strong>Background: </strong>Respiratory Syncytial Virus (RSV) is a common cause of hospitalisation in infants worldwide, causing significant morbidity and mortality. Recently, the antiviral treatment, Ziresovir, has shown promising results in a Phase III trial conducted on infants hospitalised with RSV. Based on these topline results, this study aims to investigate the cost-effectiveness of Ziresovir in the United Kingdom (UK).</p><p><strong>Methods: </strong>The cost-effective analysis (CEA) uses a proportional outcomes model using data from topline reports by the AIRFLO trial and published data to explore the effect of Ziresovir administration on hospitalised infants aged <24 months at admission. We estimated the reduction in ICU bed days and deaths and the maximum cost-effective price (MCEP) per treated individual, assuming a threshold of £20,000 per Quality-adjusted Life Year (QALY) gained.</p><p><strong>Results: </strong>Administering Ziresovir to all hospitalised infants averts four deaths (range: 2.8-4.5), 216 ICU admissions (range:160-260) and 3169 ICU bed-days (range: 2348-3804) per annum, the MCEP for Ziresovir per hospitalised infant is £429.65 (95 % CrI: £236-£771). If preterm infants are targeted, then the MCEP increases to £2108.38 (95 % Crl: £870-£3540). The MCEP for exclusively treating Infants with Chronic Lung Disease (CLD) and Congenital Heart Disease (CHD) is £6557.24 (95 % Crl: £1250 - £14,920) and £9459.44 (95 % Crl £3350-£20,300) respectively. The model is highly sensitive to changes in the efficacy of Ziresovir and the risk of ICU admission and mortality.</p><p><strong>Conclusion: </strong>Ziresovir is a cost-effective intervention for all infants hospitalised with RSV if priced below £430 per dose and strategies that exclusively treat high-risk- with CLD and CHD infants justify a higher price of £6558 and £9460 respectively. The outcomes are highly sensitive to the efficacy of Ziresovir and can be improved when the full results of the AIRFLO trial are available.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"45 ","pages":"126647"},"PeriodicalIF":0.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142901521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-25Epub Date: 2024-12-13DOI: 10.1016/j.vaccine.2024.126587
Samuel Bainbridge, Tauta Mappi, Sarah Cleaveland, Choby Chubwa, Alicia Davis, Dawn Grant, Tito Kibona, Shedrack Bwatota, Freja Larsen, Samson Lyimo, Fadhili Mshana, Ann Percival, Gabriel Shirima, Bakari Mtili, Felix Jackson Musyangi, Rigobert Tarimo, Felix Lankester, George Russell
Malignant catarrhal fever (MCF), caused by alcelaphine herpesvirus-1 (AIHV-1) transmitted from wildebeest, is a lethal cattle disease with significant impacts on East African pastoralists. Development of a live attenuated MCF vaccine has prompted research into its use in communities at risk. This study reports results from the first utilisation of the MCF vaccine in locally-owned cattle under field conditions. The study involved a primary two-dose course vaccination of 1634 cattle, followed a year later, by boost vaccination of 385 of these cattle. It aimed to: (a) evaluate the antibody response to a two-dose AlHV-1 primary vaccination course, including initial response, antibody levels after one year, and clinical events post-vaccination; (b) assess how factors like age, reproductive status, body condition, and breed influence the initial response; and (c) compare antibody responses to single- and two-dose booster protocols one year after primary vaccination. Analyses were carried out using linear mixed-effects models and paired t-tests. Clinical incidents were reported in 11/1634 cattle vaccinated during the primary course and in 0/385 cattle during the boost regimens. The primary vaccination resulted in a 9-fold increase in comparison to pre-vaccination antibody levels and the response was consistent across animals of different ages, reproductive statuses and body conditions. While antibody levels declined 11 months after primary vaccination, they remained high, and a single-dose booster vaccination was sufficient to elicit a strong immune response, with only marginal increases after a second booster. The study provides evidence of high immunogenicity and low incidences of clinical events of the vaccine in cattle across individual host factors and immunologically vulnerable groups, under prevailing environmental conditions. It also indicates the utility of a single-dose booster regimen. These findings will support progress towards commercial production and larger-scale adoption which could generate important benefits for the livelihoods, and sustainability of pastoral livestock systems.
{"title":"Field vaccination of locally-owned cattle against malignant catarrhal fever under environmentally challenging conditions in Tanzania.","authors":"Samuel Bainbridge, Tauta Mappi, Sarah Cleaveland, Choby Chubwa, Alicia Davis, Dawn Grant, Tito Kibona, Shedrack Bwatota, Freja Larsen, Samson Lyimo, Fadhili Mshana, Ann Percival, Gabriel Shirima, Bakari Mtili, Felix Jackson Musyangi, Rigobert Tarimo, Felix Lankester, George Russell","doi":"10.1016/j.vaccine.2024.126587","DOIUrl":"10.1016/j.vaccine.2024.126587","url":null,"abstract":"<p><p>Malignant catarrhal fever (MCF), caused by alcelaphine herpesvirus-1 (AIHV-1) transmitted from wildebeest, is a lethal cattle disease with significant impacts on East African pastoralists. Development of a live attenuated MCF vaccine has prompted research into its use in communities at risk. This study reports results from the first utilisation of the MCF vaccine in locally-owned cattle under field conditions. The study involved a primary two-dose course vaccination of 1634 cattle, followed a year later, by boost vaccination of 385 of these cattle. It aimed to: (a) evaluate the antibody response to a two-dose AlHV-1 primary vaccination course, including initial response, antibody levels after one year, and clinical events post-vaccination; (b) assess how factors like age, reproductive status, body condition, and breed influence the initial response; and (c) compare antibody responses to single- and two-dose booster protocols one year after primary vaccination. Analyses were carried out using linear mixed-effects models and paired t-tests. Clinical incidents were reported in 11/1634 cattle vaccinated during the primary course and in 0/385 cattle during the boost regimens. The primary vaccination resulted in a 9-fold increase in comparison to pre-vaccination antibody levels and the response was consistent across animals of different ages, reproductive statuses and body conditions. While antibody levels declined 11 months after primary vaccination, they remained high, and a single-dose booster vaccination was sufficient to elicit a strong immune response, with only marginal increases after a second booster. The study provides evidence of high immunogenicity and low incidences of clinical events of the vaccine in cattle across individual host factors and immunologically vulnerable groups, under prevailing environmental conditions. It also indicates the utility of a single-dose booster regimen. These findings will support progress towards commercial production and larger-scale adoption which could generate important benefits for the livelihoods, and sustainability of pastoral livestock systems.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"45 ","pages":"126587"},"PeriodicalIF":0.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142824996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-25Epub Date: 2025-01-13DOI: 10.1016/j.vaccine.2024.126642
Angela L Rasmussen, Ivan Hung, Florian Krammer
{"title":"Editorial.","authors":"Angela L Rasmussen, Ivan Hung, Florian Krammer","doi":"10.1016/j.vaccine.2024.126642","DOIUrl":"10.1016/j.vaccine.2024.126642","url":null,"abstract":"","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"45 ","pages":"126642"},"PeriodicalIF":0.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-25Epub Date: 2024-12-21DOI: 10.1016/j.vaccine.2024.126649
Maysa Serpa Gonçalves, Marina Martins de Oliveira, Rafaella Silva Andrade, Luciana Faria de Oliveira, Alessandro de Sá Guimarães, Jacques Godfroid, Andrey Pereira Lage, Elaine Maria Seles Dorneles
Brucella abortus S19 and RB51 are the most used vaccines to control bovine brucellosis worldwide; therefore, this study aimed to perform a systematic review on the effectiveness of these two vaccine strains in field studies. The literature review was conducted on April 3rd 2020 on six databases (CABI, Cochrane, PubMed, Scielo, Scopus and Web of Science) and included papers published between 1976 and 2016. The search strategy recovered a total of 5846 papers on databases and 6 papers were included due to specialists' suggestions. After selection, 17 papers were included, in which 33 trials were identified. Most trials [63.63 % (21/33)] used prevalence panel design (cross-sectional), while the others were cohort studies. S19 strain was used in most of the trials [75.76 % (25/33)], mainly by subcutaneous route [84.00 % (21/25)] and in adult cattle [76.00 % (19/25)]. RB51 strain was administrated only by the subcutaneous route and in both young and adult animals. For case definition, complement fixation [60.60 % (20/33)] and rivanol [30.30 % (10/33)] were the most used tests. Twenty of the 33 trials (60.61 %) showed significant effect of vaccination on brucellosis control, with lower incidence of infection in the vaccinated groups (in cohort trials) or reduced prevalence after vaccination (in prevalence panels); however, the great heterogeneity observed among the studies precluded a meta-analysis from the data extracted. In addition, most trials [57.57 % (19/33)] adopted other control measures (test-and-slaughter or isolation of positive animals from the herd) in association with vaccination, which harmed the better understand of the isolated effect of vaccination for brucellosis control in field in these studies. In conclusion, the result from this review suggests that both S19 and RB51 vaccine strains are effective in reducing brucellosis incidence in both calves and adults, as well as abortion rates, mainly when associated to other control policies.
流产布鲁氏菌S19和RB51是世界范围内控制牛布鲁氏菌病最常用的疫苗;因此,本研究旨在对这两种疫苗株在实地研究中的有效性进行系统评价。文献综述于2020年4月3日在六个数据库(CABI、Cochrane、PubMed、Scielo、Scopus和Web of Science)上进行,包括1976年至2016年间发表的论文。检索策略在数据库中共检索到5846篇论文,根据专家建议,有6篇论文被纳入。经筛选,纳入文献17篇,共鉴定试验33项。大多数试验[63.63%(21/33)]采用患病率面板设计(横断面),其他试验采用队列研究。S19菌株在大多数试验中使用[75.76%(25/33)],主要通过皮下途径使用[84.00 %(21/25)],在成年牛中使用[76.00 %(19/25)]。RB51菌株仅通过皮下给药,在幼龄和成年动物中均有效。对于病例定义,补体固定[60.60%(20/33)]和利凡诺[30.30%(10/33)]是最常用的检测方法。33项试验中有20项(60.61%)显示疫苗接种对布鲁氏菌病控制有显著影响,接种疫苗组(队列试验)的感染发生率较低,接种疫苗后的患病率降低(流行病学调查);然而,在这些研究中观察到的巨大异质性妨碍了对提取的数据进行荟萃分析。此外,大多数试验[57.57%(19/33)]在接种疫苗的同时采取了其他控制措施(试验屠宰或从畜群中隔离阳性动物),这不利于更好地了解这些研究中接种疫苗对布鲁氏菌病现场控制的孤立效果。总之,本综述的结果表明,S19和RB51疫苗株都能有效降低犊牛和成牛的布鲁氏菌病发病率,以及流产率,主要是在与其他控制政策相结合的情况下。
{"title":"Systematic review on the effectiveness of Brucella abortus S19 and RB51 vaccine strains in field studies.","authors":"Maysa Serpa Gonçalves, Marina Martins de Oliveira, Rafaella Silva Andrade, Luciana Faria de Oliveira, Alessandro de Sá Guimarães, Jacques Godfroid, Andrey Pereira Lage, Elaine Maria Seles Dorneles","doi":"10.1016/j.vaccine.2024.126649","DOIUrl":"10.1016/j.vaccine.2024.126649","url":null,"abstract":"<p><p>Brucella abortus S19 and RB51 are the most used vaccines to control bovine brucellosis worldwide; therefore, this study aimed to perform a systematic review on the effectiveness of these two vaccine strains in field studies. The literature review was conducted on April 3rd 2020 on six databases (CABI, Cochrane, PubMed, Scielo, Scopus and Web of Science) and included papers published between 1976 and 2016. The search strategy recovered a total of 5846 papers on databases and 6 papers were included due to specialists' suggestions. After selection, 17 papers were included, in which 33 trials were identified. Most trials [63.63 % (21/33)] used prevalence panel design (cross-sectional), while the others were cohort studies. S19 strain was used in most of the trials [75.76 % (25/33)], mainly by subcutaneous route [84.00 % (21/25)] and in adult cattle [76.00 % (19/25)]. RB51 strain was administrated only by the subcutaneous route and in both young and adult animals. For case definition, complement fixation [60.60 % (20/33)] and rivanol [30.30 % (10/33)] were the most used tests. Twenty of the 33 trials (60.61 %) showed significant effect of vaccination on brucellosis control, with lower incidence of infection in the vaccinated groups (in cohort trials) or reduced prevalence after vaccination (in prevalence panels); however, the great heterogeneity observed among the studies precluded a meta-analysis from the data extracted. In addition, most trials [57.57 % (19/33)] adopted other control measures (test-and-slaughter or isolation of positive animals from the herd) in association with vaccination, which harmed the better understand of the isolated effect of vaccination for brucellosis control in field in these studies. In conclusion, the result from this review suggests that both S19 and RB51 vaccine strains are effective in reducing brucellosis incidence in both calves and adults, as well as abortion rates, mainly when associated to other control policies.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"45 ","pages":"126649"},"PeriodicalIF":0.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142879291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: SARS-CoV-2 mRNA vaccine reactogenicity has raised concerns regarding the risk of rejection in solid organ transplant recipients. We explored whether SOT recipients diagnosed with acute rejection had previously received a vaccine injection within a timeframe consistent with a causal link.
Methods: We identified all SOT recipients with a diagnosis of acute rejection from 2020 to 2022 and who had previously received a SARS-CoV-2 vaccination, and analysed whether the delay between vaccination and rejection was constant.
Results: In the 45 identified patients, median delay between the last SARS-CoV-2 vaccination and the rejection was 102 days [IQR 48-178]; the continuous distribution of this delay, with no identifiable time pattern, is not in favor of a role of vaccination in rejection.
Conclusion: SARS-CoV-2 mRNA vaccination is unlikely to trigger rejection in SOT recipients.
目的:SARS-CoV-2 mRNA疫苗的反应原性引起了对实体器官移植受者排斥风险的关注。我们探讨了被诊断为急性排斥反应的SOT受者是否曾在与因果关系一致的时间框架内接受过疫苗注射。方法:选取2020年至2022年期间所有诊断为急性排斥反应并曾接种过SARS-CoV-2疫苗的SOT接受者,分析疫苗接种与排斥反应之间的延迟是否恒定。结果:在45例确诊患者中,从最后一次接种SARS-CoV-2到排斥反应的中位延迟时间为102 d [IQR 48-178];这种延迟的连续分布,没有可识别的时间模式,不利于疫苗接种在排斥反应中的作用。结论:接种SARS-CoV-2 mRNA不太可能引发SOT受者的排斥反应。
{"title":"Timing of rejection events preceded by Covid-19 mRNA vaccination in recipients of solid organ transplants.","authors":"Quentin Perrier, Johan Noble, Agnès Bonadona, Caroline Augier, Thomas Jouve, Aude Boignard, Loïc Falque, Salomé Gallet, Pierrick Bedouch, Lionel Rostaing, Olivier Epaulard","doi":"10.1016/j.vaccine.2024.126617","DOIUrl":"10.1016/j.vaccine.2024.126617","url":null,"abstract":"<p><strong>Objectives: </strong>SARS-CoV-2 mRNA vaccine reactogenicity has raised concerns regarding the risk of rejection in solid organ transplant recipients. We explored whether SOT recipients diagnosed with acute rejection had previously received a vaccine injection within a timeframe consistent with a causal link.</p><p><strong>Methods: </strong>We identified all SOT recipients with a diagnosis of acute rejection from 2020 to 2022 and who had previously received a SARS-CoV-2 vaccination, and analysed whether the delay between vaccination and rejection was constant.</p><p><strong>Results: </strong>In the 45 identified patients, median delay between the last SARS-CoV-2 vaccination and the rejection was 102 days [IQR 48-178]; the continuous distribution of this delay, with no identifiable time pattern, is not in favor of a role of vaccination in rejection.</p><p><strong>Conclusion: </strong>SARS-CoV-2 mRNA vaccination is unlikely to trigger rejection in SOT recipients.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"45 ","pages":"126617"},"PeriodicalIF":0.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142866954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}