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Re: Using observational data to explore the hypothesis that a single dose of current HPV vaccines can provide durable protection: Reply to the commentary written by Christine Velicer, Alain Luxembourg, Ya-Ting Chen, Melvin Kohn, and Alfred Saah, Merck & Co., Inc., Kenilworth, NJ, USA on the IARC-India HPV vaccine study. 关于利用观察数据探讨当前 HPV 疫苗单剂可提供持久保护的假设:回复美国新泽西州肯尼尔沃思默克公司的 Christine Velicer、Alain Luxembourg、Ya-Ting Chen、Melvin Kohn 和 Alfred Saah 就国际癌症研究机构-印度 HPV 疫苗研究撰写的评论。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2025-01-12 Epub Date: 2023-06-14 DOI: 10.1016/j.vaccine.2023.06.030
Richard Muwonge, Partha Basu
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引用次数: 0
Assessing human B cell responses to influenza virus vaccines and adjuvants in a PBMC-derived in vitro culture system 在pbmc衍生的体外培养系统中评估人B细胞对流感病毒疫苗和佐剂的反应
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-12-02 DOI: 10.1016/j.vaccine.2024.126563
Shuran Gong, Martin Beukema, Jacqueline De Vries-Idema, Anke Huckriede
In vitro systems based on human peripheral blood mononuclear cells (PBMCs) can bridge the gap between preclinical and clinical vaccine evaluation but have so far mainly been exploited to assess vaccine effects on antigen-presenting cells and T cells. Our study aimed to assess whether B cells present in PBMCs also respond to vaccines and reflect the effects of different vaccine formulations and adjuvants. We stimulated PBMCs with whole inactivated virus (WIV) or split virus (SIV) H5N1 influenza vaccine, with or without the addition of the adjuvant cytosine phosphoguanine (CpG) ODN 2395, and collected the cells and supernatants at different timepoints. B cell subsets were measured by flow cytometry, immunoglobulin (IgG) levels by ELISA, B cell-related genes by qPCR, and cytokine levels by intracellular staining. B cells differentiated more readily to plasmablasts and plasma cells and produced more IgG when PBMC cultures were stimulated with WIV than when stimulated with SIV. In line, PRDM1, XBP1, and AICDA, genes associated with the differentiation of B cells to antibody-secreting cells, were expressed at higher levels in WIV- than in SIV-stimulated PBMCs. The combination of WIV and CpG consistently induced the highest levels of antibody-secreting cell differentiation, IgG production, and B-cells secreting IL-6 and IL-10. Taken together, B cells in human PBMC cultures show distinct responses to different types of vaccines and vaccine/CpG combinations. This underlines the suitability of unfractionated PBMCs for evaluating vaccine effects on different types of human immune cells before running costly clinical trials.
基于人外周血单核细胞(PBMCs)的体外系统可以弥合临床前和临床疫苗评估之间的差距,但迄今为止主要用于评估疫苗对抗原提呈细胞和T细胞的作用。我们的研究旨在评估存在于pbmc中的B细胞是否也对疫苗产生反应,并反映不同疫苗配方和佐剂的效果。采用全灭活病毒(WIV)或分裂病毒(SIV) H5N1流感疫苗,分别添加或不添加佐剂胞嘧啶磷酸鸟嘌呤(CpG) ODN 2395刺激PBMCs,并在不同时间点收集细胞和上清液。流式细胞术检测B细胞亚群,ELISA检测免疫球蛋白(IgG)水平,qPCR检测B细胞相关基因,细胞内染色检测细胞因子水平。与SIV刺激相比,WIV刺激的PBMC培养物更容易分化为浆母细胞和浆细胞,并产生更多的IgG。与此同时,与B细胞向抗体分泌细胞分化相关的基因PRDM1、XBP1和AICDA在WIV-中表达水平高于siv -刺激的PBMCs。WIV和CpG联合使用持续诱导最高水平的抗体分泌细胞分化、IgG产生和分泌IL-6和IL-10的b细胞。综上所述,人PBMC培养中的B细胞对不同类型的疫苗和疫苗/CpG组合表现出不同的反应。这强调了在进行昂贵的临床试验之前,未分离的pbmc用于评估疫苗对不同类型人类免疫细胞的效果的适用性。
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引用次数: 0
The stability of PCV2 virus-like particles from mammalian cells and challenges for biotechnological applications 哺乳动物细胞PCV2病毒样颗粒的稳定性及其在生物技术应用中的挑战
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-12-02 DOI: 10.1016/j.vaccine.2024.126549
Natalia Olivero-Deibe , Ezequiel N. Frigini , Natalia Ramos , Federico Carrión , Florencia Fadel , Lihuén Villarreal , Juan C. Benech , Juan Arbiza , Sergio Pantano , Claudia Ortega
Porcine circovirus type 2 (PCV2) is a highly damaging pathogen for pig farming, causing significant economic losses. Despite the availability of vaccines based on different technologies, the virus steadily infects the world's pig population. In this context, virus-like particles (VLPs) constitute appealing alternatives for vaccine development as they lack the viral genome but present intact external surfaces.
Using PCV2 VLPs expressed and purified from Expi293F cells, we demonstrate the potential to generate high-purity VLPs with excellent antigenic properties through biochemical, biophysical, and immunological characterization. Using different techniques, we also determined the melting temperature of these VLPs at nearly 55 °C.
Furthermore, we conducted multiscale simulations of whole VLPs combined with multiple sequence analyses to provide a new perspective into the stability determinants. Computational results support our findings and underscore the importance of protein-nucleic acid interactions in stabilizing the VLP structure. Moreover, we spotted an unforeseen correlation between amino acid conservation, solvent exposure, and flexibility, revealing a link to viral assembly and immune evasion. These novel insights are crucial to guide the development of stabilized VLP for new vaccine prototypes to respond to the emergence of new PCV2 genotypes.
猪圆环病毒2型(PCV2)是一种对养猪业具有高度破坏性的病原体,造成重大经济损失。尽管有基于不同技术的疫苗,但该病毒仍在不断感染世界上的猪群。在这种情况下,病毒样颗粒(vlp)是疫苗开发的有吸引力的替代方案,因为它们缺乏病毒基因组,但具有完整的外表面。利用Expi293F细胞表达和纯化的PCV2 VLPs,我们通过生化、生物物理和免疫学表征证明了产生具有优异抗原性的高纯度VLPs的潜力。使用不同的技术,我们还确定了这些VLPs的熔化温度接近55°C。此外,我们对整个VLPs进行了多尺度模拟,并结合多序列分析,为研究稳定性决定因素提供了新的视角。计算结果支持我们的发现,并强调蛋白质-核酸相互作用在稳定VLP结构中的重要性。此外,我们发现氨基酸保存、溶剂暴露和灵活性之间存在不可预见的相关性,揭示了病毒组装和免疫逃避之间的联系。这些新的见解对于指导开发稳定的VLP用于新疫苗原型以应对新的PCV2基因型的出现至关重要。
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引用次数: 0
Exploring Chatbot contributions to enhancing vaccine literacy and uptake: A scoping review of the literature 探索聊天机器人对提高疫苗素养和吸收的贡献:文献范围综述
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-30 DOI: 10.1016/j.vaccine.2024.126559
Claudia Cosma , Alessio Radi , Rachele Cattano , Patrizio Zanobini , Guglielmo Bonaccorsi , Chiara Lorini , Marco Del Riccio

Background

The increasing integration of chatbots across various sectors marks a significant shift in digital communication, and their role in healthcare makes no exception. This scoping review aims to systematically examine the role of chatbots in the perspective of organizational vaccine literacy, particularly in enhancing vaccine literacy and facilitating the dissemination of vaccine-related information, evaluating the potential of chatbots to transform vaccination communication strategies and improve health education outcomes.

Methods

This scoping review adhered to the Joanna Briggs Institute methodology and the PRISMA-ScR checklist. A systematic search of MEDLINE, Embase, Scopus, and PsycInfo was conducted from January 2020 to October 30, 2024, using keywords related to “chatbots” and “vaccination.” Study selection involved a two-stage screening process, focusing on studies reporting the use of chatbots to improve vaccine literacy and uptake. Data were thematically analyzed and presented in a narrative format.

Results

Twenty-two studies were included in the review: these studies demonstrate the effectiveness of chatbots in enhancing vaccine literacy and acceptance, mainly focusing on COVID-19 but also addressing HPV and childhood vaccinations. They highlight chatbots' role in improving the vaccine-literate environment through countering misinformation and improving communication with healthcare professionals, showcasing their potential to significantly influence public health outcomes and their adaptability to diverse populations and geographic regions.

Conclusions

These digital assistants could provide personalized and up-to-date information, improving not only knowledge but also attitudes and intentions towards vaccinations.
聊天机器人在各个领域的日益融合标志着数字通信的重大转变,它们在医疗保健领域的作用也不例外。本综述旨在系统地研究聊天机器人在组织疫苗素养方面的作用,特别是在提高疫苗素养和促进疫苗相关信息传播方面的作用,评估聊天机器人改变疫苗接种沟通策略和改善健康教育成果的潜力。方法本综述遵循乔安娜布里格斯研究所的方法和PRISMA-ScR检查表。从2020年1月到2024年10月30日,使用与“聊天机器人”和“疫苗接种”相关的关键词对MEDLINE、Embase、Scopus和PsycInfo进行了系统检索。研究选择包括两个阶段的筛选过程,重点是报告使用聊天机器人提高疫苗素养和吸收的研究。数据按主题进行分析,并以叙述形式呈现。结果本综述纳入了22项研究:这些研究证明了聊天机器人在提高疫苗素养和接受度方面的有效性,主要关注COVID-19,但也涉及HPV和儿童疫苗接种。他们强调了聊天机器人通过打击错误信息和改善与医疗保健专业人员的沟通,在改善疫苗识字环境方面的作用,展示了它们对公共卫生结果产生重大影响的潜力,以及它们对不同人群和地理区域的适应性。结论这些数字助理可以提供个性化和最新的信息,不仅提高了知识,而且提高了对疫苗接种的态度和意图。
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引用次数: 0
Human papillomavirus vaccination coverage among adolescent boys and girls in the United States: A birth year cohort analysis of the National Immunization Survey-Teen, 2016–2022. 美国青春期男孩和女孩的人乳头瘤病毒疫苗接种覆盖率:2016-2022年国家免疫调查青少年的出生年份队列分析
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-30 DOI: 10.1016/j.vaccine.2024.126560
Ponesai Nyika, David Yankey, Laurie D. Elam-Evans, S. Meyer, C. Pingali, Shannon Stokley, James A. Singleton

Objective

To evaluate human papillomavirus (HPV) vaccination coverage among adolescents in the U.S. using birth cohort analysis.

Methods

We conducted a birth cohort analysis among adolescents born during 1999–2009 using National Immunization Survey-Teen (NIS-Teen), a random-digit dialed household telephone survey that also includes vaccination data from providers. We analyzed 131,553 records from 2016 to 2022 NIS-Teen data to determine: trends in coverage with ≥1 HPV vaccine dose before age 13 years and cumulative coverage from age 13–17 years; sociodemographic factors associated with HPV vaccination before age 13 years; missed HPV vaccination opportunities and the potential achievable coverage if opportunities were not missed; and trends in completion of HPV vaccination series. Regression analysis and Kaplan-Meier method provided the average percentage increase in coverage, and cumulative coverage from age 13–17 years stratified by birth cohorts, respectively.

Results

HPV vaccination initiation before age 13 years increased from 27.0 % among adolescents born in 1999 to 69.8 % among those born in 2009. Overall, cumulative percent with ≥1 HPV vaccine dose increased from 51.3 % before age 13 years to 74.9 % through age 17 years. Having a preventive visit at ages 11–12 years and being insured were associated with higher ≥1 HPV vaccine dose coverage. Among the 38,568 (29.3 %) adolescents unvaccinated for HPV, 31,513 (82.5 %) missed ≥1 HPV vaccination opportunity. The potential achievable coverage if opportunities were not missed was 94.8 %. Completion of HPV vaccination series before age 13 years increased from 10.3 % among adolescents born in 1999 to 42.2 % among those born in 2009.

Conclusions

Coverage with ≥1 HPV vaccine dose increased by birth cohort among adolescents born 1999–2009 but remained suboptimal, especially among uninsured adolescents. Missed opportunities may be reduced by effective HPV vaccination implementation and uptake strategies and by administering all recommended vaccines during the same visit.
目的利用出生队列分析评估美国青少年人乳头瘤病毒(HPV)疫苗接种覆盖率。方法我们使用国家青少年免疫调查(NIS-Teen)对1999-2009年出生的青少年进行了出生队列分析,这是一项随机数字拨打的家庭电话调查,也包括来自提供者的疫苗接种数据。我们分析了2016年至2022年NIS-Teen数据的131,553条记录,以确定:13岁前≥1剂HPV疫苗的覆盖率趋势和13 - 17岁的累积覆盖率;与13岁前HPV疫苗接种相关的社会人口因素;错过了人乳头瘤病毒疫苗接种机会,如果没有错过机会,可能实现的覆盖率;以及完成HPV系列疫苗接种的趋势。回归分析和Kaplan-Meier方法分别提供了按出生队列分层的13-17岁的平均覆盖率增加百分比和累积覆盖率。结果13岁前接种疫苗的比例从1999年出生的27.0%上升到2009年出生的69.8%。总体而言,接种≥1剂HPV疫苗的累积百分比从13岁前的51.3%增加到17岁时的74.9%。在11-12岁时进行预防性访问并投保与较高的≥1 HPV疫苗剂量覆盖率相关。在38,568名(29.3%)未接种HPV疫苗的青少年中,31,513名(82.5%)错过了≥1次HPV疫苗接种机会。如果不错过机会,潜在的可实现覆盖率为94.8%。在1999年出生的青少年中,在13岁之前完成HPV疫苗系列接种的比例从10.3%增加到2009年出生的青少年中的42.2%。结论:在1999-2009年出生的青少年中,接种≥1剂HPV疫苗的覆盖率随出生队列的增加而增加,但仍然不够理想,特别是在未投保的青少年中。通过有效的HPV疫苗接种实施和吸收策略以及在同一次就诊期间接种所有推荐的疫苗,可以减少错过的机会。
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引用次数: 0
The effectiveness of vaccines against COVID-19 in Mexico: A time series approach 墨西哥COVID-19疫苗的有效性:时间序列方法
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-30 DOI: 10.1016/j.vaccine.2024.126565
D. Flores, E.M. Luna

Objective

To estimate the effectiveness of several vaccine brands—Pfizer, Astra, and Sinovac—against symptomatic COVID-19 without information on vaccination at the individual level.

Methods

We use data of mass vaccination programs—specifically, for sexagenarians and quinquagenarians—in three large municipalities of Mexico (Monterrey, Guadalupe, and San Nicolás) to conduct a two-step time series estimation procedure involving a synthetic control group. The data covers the period between the first week of March 2020 and the first week of October 2021.

Results

Vaccine effectiveness is a concave function of time. At the peak, Pfizer reaches 92.6 % effectiveness, Astra 83.6 % and Sinovac 65.6 %. This occurs 9 to 12 weeks after the first shot.

Conclusion

The results indicate that the three vaccines protect against symptomatic COVID-19. Nevertheless, they offer different levels of protection. The results also suggest that VE—under a two-shot scheme—reaches its peak 9 to 16 weeks after the first shot. Moreover, there seems to be a trade-off between achieving higher efficiency by administering the 2nd shot earlier or extending the protection period by administering it later.
目的在不提供个体疫苗接种信息的情况下,评估几种疫苗品牌(辉瑞、阿斯特拉和sinovac)对症状性COVID-19的有效性。方法我们使用墨西哥三个大城市(蒙特雷、瓜达卢佩和圣Nicolás)的大规模疫苗接种计划的数据,特别是针对六十岁和五岁老人的数据,进行涉及合成对照组的两步时间序列估计程序。数据涵盖2020年3月第一周至2021年10月第一周期间。结果疫苗有效性与时间呈凹函数关系。在高峰时期,辉瑞的有效性为92.6%,阿斯特拉为83.6%,科兴为65.6%。这发生在第一次注射后的9到12周。结论三种疫苗对症状性COVID-19均有保护作用。然而,它们提供了不同程度的保护。结果还表明,在两次注射方案下,ve在第一次注射后9至16周达到峰值。此外,在更早接种第二针或更晚接种延长保护期之间似乎存在权衡。
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引用次数: 0
Respiratory syncytial virus (RSV) prevention: Perception and willingness of expectant parents in the Netherlands 呼吸道合胞病毒(RSV)预防:荷兰准父母的认知和意愿
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-30 DOI: 10.1016/j.vaccine.2024.126541
Lisette M. Harteveld , Lisanne M. van Leeuwen , Sjoerd M. Euser , Lucy J. Smit , Karlijn C. Vollebregt , Debby Bogaert , Marlies A. van Houten

Background

Respiratory syncytial virus (RSV) is a leading cause of infant respiratory disease. Recent approval of preventive measures like a long-acting monoclonal antibody and a maternal vaccine signals a potential shift in early-life RSV infection control. However, success hinges on acceptance.

Methods

We conducted a cross-sectional survey among pregnant women and partners in the Netherlands, recruited via healthcare professionals, social media platforms, and the 9-Months Fair. The survey assessed willingness and motivation for maternal RSV vaccination and neonatal RSV immunization, including strategy preferences and informational needs.

Results

In total 1001 pregnant women (mean age: 31.1 years) and their partners (mean age: 33.2 years) completed the survey. On average, they were 24 weeks pregnant at the time, and 54.6 % had no other children yet. The majority was Dutch-born (95.2 % of women); with 68.3 % of women having completed higher education and with overall strong pro-vaccination attitudes (93.9 % of partners intended to vaccinate their expected newborn). The overall acceptability to vaccination and immunization was high, with 87 % of respondents indicating they would (likely) accept both strategies. A positive attitude towards both methods was associated with previous experience with severity of RSV, intention to vaccinate the newborn and parental vaccination status during childhood and current pregnancy. When the choice was given, the majority of participants, in particular those with children and the intention to breastfeed, favoured maternal vaccination over passive immunization of infants (75.3 % of the pregnant and 71.6 % of the partners). A majority of the respondents cited optimal protection for the child and knowledge of RSV as important factors for accepting RSV prophylaxis.

Conclusions

While most participants would accept both strategies for RSV protection of their infant, a majority, especially those with other children, favoured maternal vaccination, due to concerns about infant safety and awareness of RSV severity.
呼吸道合胞病毒(RSV)是婴儿呼吸道疾病的主要病因。最近批准的预防措施,如长效单克隆抗体和母亲疫苗,标志着生命早期RSV感染控制的潜在转变。然而,成功取决于接受。方法:我们对荷兰的孕妇及其伴侣进行了横断面调查,通过医疗保健专业人员、社交媒体平台和9个月博览会招募。该调查评估了母亲接种RSV疫苗和新生儿接种RSV疫苗的意愿和动机,包括策略偏好和信息需求。结果共1001名孕妇(平均年龄31.1岁)及其伴侣(平均年龄33.2岁)完成调查。平均而言,她们当时怀孕24周,54.6%的人还没有其他孩子。大多数是荷兰出生的(95.2%的女性);68.3%的妇女完成了高等教育,总体上持强烈的支持接种态度(93.9%的伴侣打算为其预期新生儿接种疫苗)。疫苗接种和免疫的总体可接受性很高,87%的答复者表示他们(可能)接受这两种战略。对这两种方法的积极态度与以往呼吸道合胞病毒严重程度的经验、新生儿接种意愿以及父母在儿童期和当前妊娠期间的疫苗接种情况有关。在进行选择时,大多数参与者,特别是那些有孩子并打算母乳喂养的参与者,倾向于母亲接种疫苗,而不是婴儿被动免疫(孕妇的75.3%和伴侣的71.6%)。大多数应答者认为对儿童的最佳保护和对呼吸道合胞病毒的了解是接受呼吸道合胞病毒预防的重要因素。结论:虽然大多数参与者会接受这两种策略来保护他们的婴儿,但大多数人,特别是那些有其他孩子的人,出于对婴儿安全性的考虑和对RSV严重程度的认识,倾向于母亲接种疫苗。
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引用次数: 0
The evidence base for rotavirus vaccination in India: Current status, future needs 印度轮状病毒疫苗接种的证据基础:现状和未来需求
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-29 DOI: 10.1016/j.vaccine.2024.126551
Niranjan Bhat , Elisabeth Vodicka , Allison Clifford , Kanduri Balaji Ananth , Ashish Bavdekar , Arup Deb Roy , Umesh Parashar , Jacqueline Tate , Pradeep Haldar , Gagandeep Kang
Rotavirus is a leading cause of severe diarrheal disease in infants and young children worldwide. Vaccination offers the best protection against this disease, and two rotavirus vaccines were developed in India and included in its routine immunization program. The Government of India's decision to adopt this intervention was supported by a solid base of evidence from clinical trials, as well as substantial research regarding rotavirus disease burden and the potential health and economic value of immunization. Following program implementation, multiple studies were initiated, including three evaluations of effectiveness and several investigations regarding intussusception. These additional data regarding vaccine impact, safety, and delivery from post-introduction evaluations in conditions of real-world use will further strengthen and sustain the immunization program. This manuscript evaluates the status of existing and forthcoming evidence regarding rotavirus vaccination in India through a literature review and consultation with relevant stakeholders. Studies evaluating vaccine impact, effectiveness, safety, health economics, and acceptability, as well as operational and programmatic research, were included in the review. Overall, we found that the evidence base did not contain any major gaps. Nevertheless, additional smaller-scale research studies would be valuable in providing a more complete picture of rotavirus vaccine performance and benefit. Documentation of India's experience with rotavirus vaccines may provide lessons learned for other countries in the Asia region, where rotavirus disease burden remains high, yet vaccine adoption has been slow, as well as for countries worldwide that may be considering implementation of the Indian-made rotavirus vaccines.
轮状病毒是全世界婴幼儿严重腹泻疾病的主要原因。接种疫苗是预防这种疾病的最佳方法,印度开发了两种轮状病毒疫苗,并将其纳入常规免疫规划。印度政府采取这一干预措施的决定得到了临床试验的坚实证据基础以及关于轮状病毒疾病负担和免疫接种的潜在健康和经济价值的大量研究的支持。项目实施后,开展了多项研究,包括三项有效性评估和几项关于肠套叠的调查。这些关于疫苗影响、安全性和实际使用条件下引入后评估的额外数据将进一步加强和维持免疫规划。本文通过文献综述和咨询相关利益攸关方,评估了印度轮状病毒疫苗接种的现有和即将出现的证据状况。评估疫苗影响、有效性、安全性、卫生经济学和可接受性的研究以及业务和规划研究被纳入审查。总的来说,我们发现证据基础没有任何重大差距。然而,更多的小规模研究对于更全面地了解轮状病毒疫苗的性能和益处是有价值的。印度在轮状病毒疫苗方面的经验可以为亚洲区域的其他国家提供经验教训,这些国家的轮状病毒疾病负担仍然很高,但疫苗的采用速度很慢,也可以为世界上可能正在考虑实施印度制造的轮状病毒疫苗的国家提供经验教训。
{"title":"The evidence base for rotavirus vaccination in India: Current status, future needs","authors":"Niranjan Bhat ,&nbsp;Elisabeth Vodicka ,&nbsp;Allison Clifford ,&nbsp;Kanduri Balaji Ananth ,&nbsp;Ashish Bavdekar ,&nbsp;Arup Deb Roy ,&nbsp;Umesh Parashar ,&nbsp;Jacqueline Tate ,&nbsp;Pradeep Haldar ,&nbsp;Gagandeep Kang","doi":"10.1016/j.vaccine.2024.126551","DOIUrl":"10.1016/j.vaccine.2024.126551","url":null,"abstract":"<div><div>Rotavirus is a leading cause of severe diarrheal disease in infants and young children worldwide. Vaccination offers the best protection against this disease, and two rotavirus vaccines were developed in India and included in its routine immunization program. The Government of India's decision to adopt this intervention was supported by a solid base of evidence from clinical trials, as well as substantial research regarding rotavirus disease burden and the potential health and economic value of immunization. Following program implementation, multiple studies were initiated, including three evaluations of effectiveness and several investigations regarding intussusception. These additional data regarding vaccine impact, safety, and delivery from post-introduction evaluations in conditions of real-world use will further strengthen and sustain the immunization program. This manuscript evaluates the status of existing and forthcoming evidence regarding rotavirus vaccination in India through a literature review and consultation with relevant stakeholders. Studies evaluating vaccine impact, effectiveness, safety, health economics, and acceptability, as well as operational and programmatic research, were included in the review. Overall, we found that the evidence base did not contain any major gaps. Nevertheless, additional smaller-scale research studies would be valuable in providing a more complete picture of rotavirus vaccine performance and benefit. Documentation of India's experience with rotavirus vaccines may provide lessons learned for other countries in the Asia region, where rotavirus disease burden remains high, yet vaccine adoption has been slow, as well as for countries worldwide that may be considering implementation of the Indian-made rotavirus vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126551"},"PeriodicalIF":4.5,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142746144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: A randomised, comparator-controlled, phase 2 trial 表达SARS-CoV-2刺突的灭活重组新城疫病毒疫苗的安全性和免疫原性:一项随机、比较对照的2期试验
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-29 DOI: 10.1016/j.vaccine.2024.126542
Vu Dinh Thiem , Dang Duc Anh , Vu Hai Ha , Nguyen Van Thom , Tran Cong Thang , Jose Mateus , Juan Manuel Carreño , Rama Raghunandan , Nguyen Mai Huong , Laina D. Mercer , Jorge Flores , E. Alexandar Escarrega , Ariel Raskin , Duong Huu Thai , Le Van Be , Alessandro Sette , Bruce L. Innis , Florian Krammer , Daniela Weiskopf
<div><div>Abstract</div><div>Production of affordable coronavirus disease 2019 (COVID-19) vaccines in low- and lower-middle-income countries is needed. NDV-HXP-S is an inactivated egg-based recombinant Newcastle disease virus vaccine expressing the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A public sector manufacturer in Vietnam assessed the immunogenicity of NDV-HXP-S (COVIVAC) relative to an authorized vaccine.</div><div>This phase 2 stage of a randomised, observer-blind, controlled, phase 1/2 trial was conducted at three community health centers in Thai Binh Province, Vietnam. Healthy males and non-pregnant females, 18 years of age and older, were eligible. Participants were randomised by age (18–59, ≥60 years) to receive one of three treatments by intramuscular injection twice, 28 days apart: COVIVAC at 3 μg or 6 μg, or AstraZeneca COVID-19 vaccine VAXZEVRIA™. Participants and personnel assessing outcomes were masked to treatment. The vaccine dose was selected based on Phase 1 results. A 6 μg dose was chosen to explore the immunogenicity gain over the 3-μg dose.</div><div>The study's aim is to evaluate the safety and immunogenicity of COVIVAC at two dose levels compared to VAXZEVRIA, the most commonly used COVID-19 vaccine in Vietnam. The main outcome was the induction of 50% neutralising antibody titers against vaccine-homologous pseudotyped virus 14 days (day 43) and 6 months (day 197) after the second vaccination by age group. The primary immunogenicity and safety analyses included all participants who received one dose of the vaccine. <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT05940194</span><svg><path></path></svg></span>.</div><div>During August 10–23, 2021, 737 individuals were screened, and 374 were randomised (124–125 per group); all subjects received vaccine dose one and all but three received doses two four weeks later. Subjects 18–59 years of age achieved the following geometric mean titers of PNA 14 days after vaccine dose two: 153⋅28 (95 % CI 124·2–189⋅15) for COVIVAC 3 μg, 176⋅2 (95 % CI 141⋅45–220.27) for COVIVAC 6 μg, and 99⋅92(95 % CI 80.80–123⋅56) for VAXZEVRIA. Subjects ≥60 years of age also achieved potent geometric mean titers of PNA at the same timepoint: 183⋅57 (95 % CI 133.4–252⋅61) for COVIVAC 3 μg, 257⋅87 (95 % CI 181⋅6–367⋅18) for COVIVAC 6 μg, and 79⋅49(95 % CI 55⋅68–113⋅4) for VAXZEVRIA.</div><div>On day 43, the geometric mean fold rise of 50 % neutralising antibody titers for subjects age 18–59 years was 31·20 (COVIVAC 3 μg <em>N</em> = 82, 95 % CI 25·14–38·74), 35·80 (COVIVAC 6 μg; <em>N</em> = 83, 95 % CI 29·03–44·15), 18·85 (VAXZEVRIA; N = 82, 95 % CI 15·10–23·54), and for subjects age ≥ 60 years was 37·27 (COVIVAC 3 μg; <em>N</em> = 42, 95 % CI 27·43–50·63), 50·10 (COVIVAC 6 μg; <em>N</em> = 40, 95 % CI 35·46–70·76), 16·11 (VAXZEVRIA; N = 40, 95 % CI 11·73–22·13). Among subjects seronegative for anti-S IgG at baseline, the day 43 g
需要在低收入和中低收入国家生产负担得起的2019冠状病毒病(COVID-19)疫苗。NDV-HXP-S是一种表达严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)刺突蛋白的重组新城疫病毒灭活疫苗。越南一家公共部门生产商评估了NDV-HXP-S (COVIVAC)相对于一种获批疫苗的免疫原性。这是一项随机、观察者盲、对照、1/2期试验的2期,在越南泰平省的三个社区卫生中心进行。18岁及以上的健康男性和未怀孕女性均符合条件。参与者按年龄(18-59岁,≥60岁)随机分组,接受肌肉注射治疗2次,间隔28天:COVIVAC剂量为3 μg或6 μg,或阿斯利康COVID-19疫苗VAXZEVRIA™。参与者和评估结果的人员对治疗不知情。疫苗剂量是根据第一阶段的结果选择的。选择6 μg剂量,考察免疫原性较3 μg剂量的增益。该研究的目的是与越南最常用的COVID-19疫苗VAXZEVRIA相比,在两个剂量水平上评估COVIVAC的安全性和免疫原性。主要结果是在按年龄组第二次接种后14天(第43天)和6个月(第197天)诱导针对疫苗同源伪型病毒的50%中和抗体滴度。初级免疫原性和安全性分析包括所有接受一剂疫苗的参与者。ClinicalTrials.gov NCT05940194。在2021年8月10日至23日期间,对737人进行了筛查,并将374人随机分组(每组124-125人);所有受试者都接种了第一剂疫苗,除三人外,所有受试者都在四周后接种了第二剂疫苗。18-59岁受试者在第二次接种后14天的PNA几何平均滴度如下:COVIVAC 3 μg为153⋅28 (95% CI 124·2 - 189⋅15),COVIVAC 6 μg为176⋅2 (95% CI 141⋅45-220.27),VAXZEVRIA为99⋅92(95% CI 80.80-123⋅56)。年龄≥60岁的受试者在同一时间点也获得了有效的PNA几何平均滴度:COVIVAC 3 μg为183⋅57 (95% CI 133.4-252⋅61),COVIVAC 6 μg为257⋅87 (95% CI 181⋅6 - 367⋅18),VAXZEVRIA为79⋅49(95% CI 55⋅68-113⋅4)。在第43天,18-59岁受试者50%中和抗体滴度的几何平均倍数上升为31.20 (COVIVAC 3 μg N = 82, 95% CI 25.14 - 38.74), 35.80 (COVIVAC 6 μg;N = 83, 95% ci为29.03 - 44.15),18.85 (vaxzevria;N = 82, 95% CI为15.10 ~ 23.54),年龄≥60岁的受试者为37.27 (COVIVAC 3 μg;N = 42岁,95% CI 27·43-50·63),50·10 (COVIVAC 6μg;N = 40, 95% ci 35·46-70·76),16·11 (vaxzevria;N = 40, 95% ci 11.73 - 22.13)。在基线抗s IgG血清阴性受试者中,18-59岁受试者第43天中和抗体(COVIVC 6 μg/VAXZEVRIA)几何平均滴度比为1.77 (95% CI 1.30 ~ 2.40),≥60岁受试者第43天中和抗体(COVIVC 6 μg/VAXZEVRIA)几何平均滴度比为3.24 (95% CI 1.98 ~ 5.32)。第197天,年龄比分别为1.11 (95% CI 0.51 ~ 0.43)和2.32(0.69 ~ 7.85)。疫苗耐受性良好;反应原性主要是轻微和短暂的。接种疫苗后28天发生非主动不良事件(ae)的受试者比例在不同治疗组中相似(COVIVAC 3 μg 29.0%、COVIVAC 6 μg 23.2%、VAXZEVRIA 31.2%);未见与疫苗相关的AE报告。考虑到针对SARS-CoV-2的中和抗体的诱导与包括VAXZEVRIA在内的COVID-19疫苗的疗效相关,我们的研究结果表明,接种COVIVAC可能提供与VAXZEVRIA疫苗相当或超过的临床效益
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引用次数: 0
Addressing vaccine misinformation: The critical need for complete product information disclosure 解决疫苗错误信息:全面披露产品信息的迫切需要
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-29 DOI: 10.1016/j.vaccine.2024.126558
Peter J. Pitts , Gregory A. Poland
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引用次数: 0
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Vaccine
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