Vaccine: X最新文献

{"title":"A phase 3, randomised, observer-blinded, placebo controlled-trial evaluating the safety and immunogenicity of investigational SARS-CoV-2 mRNA vaccine CVnCoV in adult healthcare workers in Mainz (Germany)","authors":"Frank Kowalzik ,&nbsp;Daniel Teschner ,&nbsp;Margarida Mesquita ,&nbsp;Christian Jensen ,&nbsp;Daniel Schreiner ,&nbsp;Kai Kronfeld ,&nbsp;Marija Tubic-Grozdanis ,&nbsp;Darline Cheatham-Seitz ,&nbsp;Franziska Hettich ,&nbsp;Gianluca Quintini ,&nbsp;Oliver Schoenborn-Kellenberger ,&nbsp;Paula Codó ,&nbsp;Philipp von Eisenhart-Rothe ,&nbsp;Philipp Mann ,&nbsp;Lidia Oostvogels ,&nbsp;Stephan Gehring","doi":"10.1016/j.jvacx.2024.100512","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100512","url":null,"abstract":"<div><h3>Background</h3><p>CV-NCOV-005 was conducted to generate additional safety and immunogenicity data for the former CVnCoV SARS-CoV-2 mRNA vaccine candidate in healthcare workers (HCW).</p></div><div><h3>Methods</h3><p>Randomised, observer blinded, placebo-controlled, phase 3 trial performed at the University Medical Center Mainz, Germany. HCWs aged ≥18 years with no history of SARS-CoV-2 infection/positive serology were randomly assigned to receive two doses of CVnCoV, or two doses of placebo (0.9% NaCl). The primary objectives were to expand the safety database of CVnCoV and assess antibody responses against SARS-CoV-2. Primary safety and reactogenicity outcomes included solicited adverse events (AEs) within 7 days after each dose and unsolicited AEs within 28 days after each dose, with safety follow-up for 13 months after first vaccination. Since HCWs became eligible to receive an authorised vaccine during enrolment and efficacy results from HERALD CVnCoV trial were made available on 30^th of June 2021, this study was unblinded and converted to an open label design.</p></div><div><h3>Results</h3><p>Most participants in the CVnCoV group reported at least one solicited AE, a relatively high number being Grade 3 (43.3% in CVnCoV group and 6.4% in placebo group). Most AEs were short in duration and did not affect vaccine compliance. The percentage of participants with unsolicited AEs up to 28 days after any dose was slightly higher in CVnCoV group (37.0%) compared with placebo group (31.2%). IgG binding antibodies against the receptor binding domain of the SARS-CoV-2 spike protein were observed after vaccination, with higher seroconversion rates and antibody levels after the second dose.</p></div><div><h3>Conclusion</h3><p>No safety concerns for CVnCoV were identified up to 1 year post second dose. IgG responses against SARS-CoV-2 were observed after two doses, with a higher seroconversion rate and antibody levels observed after second vaccination.</p><p>Study registration: <u>ClinicalTrials.gov</u> NCT04674189, study period: 23^rd of December 2020 to 8^th of June 2022.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100512"},"PeriodicalIF":2.7,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000858/pdfft?md5=92a7f2742ef0cd69e9a1686ba30d337d&pid=1-s2.0-S2590136224000858-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141483763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Workshop on the design and use of clinical trials with multiple endpoints, with a focus on prevention of RSV","authors":"O. Prunas ,&nbsp;J. Willemsen ,&nbsp;J.L. Warren ,&nbsp;L. Bont ,&nbsp;J.L. Schwartz ,&nbsp;J. Atwell ,&nbsp;E. Begier ,&nbsp;N. Dean ,&nbsp;I. Hirsch ,&nbsp;R. Karron ,&nbsp;K. Klugman ,&nbsp;R. Kramer ,&nbsp;E. Leidman ,&nbsp;R. Link-Gelles ,&nbsp;H. Nair ,&nbsp;CA. Panozzo ,&nbsp;E. Pelfrene ,&nbsp;E.A.F. Simões ,&nbsp;P.G. Smith ,&nbsp;P. Srikantiah ,&nbsp;D.M. Weinberger","doi":"10.1016/j.jvacx.2024.100509","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100509","url":null,"abstract":"<div><p>A meeting held in Lisbon, Portugal, in February 2023 focused on critical aspects of clinical trial design for respiratory syncytial virus (RSV) preventative therapies. The meeting addressed two primary areas: enhancing the efficiency and success of randomized controlled trials (RCTs) for RSV preventative therapies and designing RCTs to better inform post-licensure decision-making. Topics included the selection of primary endpoints, innovative approaches to incorporating multiple endpoints and historical data, and the challenges and benefits of sequential trial designs. The discussion also touched on <em>meta</em>-regression models for obtaining more robust, context-specific estimates of vaccine efficacy. Overall, the meeting underscored the importance of balancing efficiency and robustness in RSV vaccine trial design, while recognizing the need for further discussions involving regulatory and advisory bodies.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100509"},"PeriodicalIF":3.8,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000822/pdfft?md5=3a8eb7622f4dd3ab85e6f48a9d90467c&pid=1-s2.0-S2590136224000822-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141303422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Why did I participate in an HIV vaccine study? Experiences of participation in the first phase II HIV vaccine trial in Mozambique: An ancillary study using a mixed-method approach","authors":"Igor P. Ubisse Capitine ,&nbsp;Álvaro Marcela Manhiça ,&nbsp;Paulo Tembe Júnior ,&nbsp;Patrícia M. Ramgi ,&nbsp;Sérgio Chicumbe ,&nbsp;Arne Kroidl ,&nbsp;Martin R. Fischer ,&nbsp;Caroline De Schacht","doi":"10.1016/j.jvacx.2024.100510","DOIUrl":"10.1016/j.jvacx.2024.100510","url":null,"abstract":"<div><h3>Introduction</h3><p>This study recognized the lack of information regarding recruitment and retention factors associated with implementing HIV vaccine trials from the perspective of <em>de facto</em> participants. It aimed to describe the motives and experiences of 31 young adults who participated in a phase II HIV vaccine clinical trial conducted in Maputo, Mozambique.</p></div><div><h3>Methods</h3><p>This was an ancillary study with a mixed-method approach that employed a convergent design, combining both quantitative and qualitative methodologies. Data collection involved questionnaire surveys, in-depth interviews, and focus group discussions. Participants were assessed before and after learning whether they received the experimental vaccine or placebo. Thematic analysis was used for qualitative data, while descriptive analysis and statistical tests such as Fischer’s test and McNemar’s exact test were applied to quantitative data. The study also utilized the Health Belief Model to understand the decision-making process of participating in an HIV vaccine study.</p></div><div><h3>Results</h3><p>Most of our participants were young females, single, with limited financial resources. Participants joined the trial with the belief that they had a unique opportunity to help the fight against HIV and contribute to the research for the discovery of an HIV vaccine. Positive experiences related to trial participation include gaining knowledge about HIV and personal health and receiving risk reduction counseling. Participants reported blood collection as a negative experience and that they suffered social harm because of trial participation. Participants felt abandoned after the trial ended.</p></div><div><h3>Conclusion</h3><p>Preventive HIV vaccine trials should integrate a social-behavioral component to assess reasons for participation and refusal in real-time. Providing ongoing personal attention is crucial for young individuals who have committed 1–2 years to trial participation, extending beyond the trial period. Implementing tailored strategies for HIV risk assessment and reduction during and after the trial is essential. Addressing these factors can enhance preventive HIV vaccine trial implementation.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100510"},"PeriodicalIF":2.7,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000834/pdfft?md5=dd9d26c5e9a18dcffd9619f292ca6c9b&pid=1-s2.0-S2590136224000834-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141414038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impacts of COVID-19 vaccine boosters on clinical outcomes associated with the Omicron variant in China: A cross-sectional survey","authors":"Haisu Feng ,&nbsp;Jiayue Chen ,&nbsp;Jiatong Sun,&nbsp;Yawen Jiang","doi":"10.1016/j.jvacx.2024.100508","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100508","url":null,"abstract":"<div><h3>Objective</h3><p>To investigate the real-world effectiveness of COVID-19 vaccine boosters during China’s Omicron wave.</p></div><div><h3>Methods</h3><p>In January 2023, we surveyed Shenzhen, China residents via online questionnaires to investigate their COVID-19 symptoms and vaccination history. The outcomes of interest included fever, other COVID-19-related symptoms, severity of symptoms, whether early onset (before December 23, 2022) and duration. Respondents were categorized as no booster, one booster 6mo ago, one booster within 6mo, or two boosters based on dose count and vaccination timing. We used multivariable logistic regressions and Tobit models to assess COVID-19 vaccine booster impacts.</p></div><div><h3>Results</h3><p>Compared to the no booster group, two booster recipients had a lower fever risk (OR = 0.35, 95 %CI = 0.16–0.76) but not lower risks of COVID-19-related symptoms (OR = 0.74, 95 %CI = 0.26–2.06) and self-reported severe symptoms (OR = 0.47, 95 %CI = 0.19–1.15). Nor did the two booster recipients had a shorter illness duration (marginal effect = -0.79 days, 95 %CI = -1.65–0.07) and a lower risk of symptom onset delay (OR = 0.48, 95 %CI = 0.19–1.23). Compared to the no booster group, both one booster within six months (OR = 2.17, 95 %CI = 1.34–3.52) and one booster six months ago (OR = 1.30, 95 %CI = 0.92–1.82) did not reduce the risks of fever and symptoms (one booster within six months: OR = 1.57, 95 %CI = 0.84–2.90; one booster six months ago: OR = 1.23, 95 %CI = 0.79–1.93). Regardless of timing, one booster did not reduce illness duration (within six months: marginal effect = 0.25 days, 95 %CI = -0.20–0.70; six months ago: marginal effect = 0.27 days, 95 %CI = -0.08–0.62). However, receiving one booster within six months delayed symptom onset (OR = 0.54, 95 %CI = 0.34–0.86), while one booster six months ago did not (OR = 1.03, 95 %CI = 0.74–1.44).</p></div><div><h3>Conclusions</h3><p>Receiving two booster doses reduced the onset of fever during the Omicron outbreak in mainland China.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100508"},"PeriodicalIF":3.8,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000810/pdfft?md5=7d5a3db69aee92b474f24375cb695216&pid=1-s2.0-S2590136224000810-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141294488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A qualitative assessment of influenza vaccine uptake among children in Kenya","authors":"Nzisa Liku ,&nbsp;Caroline Mburu ,&nbsp;Kathryn E. Lafond ,&nbsp;Malembe Ebama ,&nbsp;Mamu Athman ,&nbsp;Salma Swaleh ,&nbsp;Isaac Jewa ,&nbsp;Elen Ngware ,&nbsp;Virginia Njenga ,&nbsp;Elizabeth Kiptoo ,&nbsp;Catherine Munyao ,&nbsp;Christine Miano ,&nbsp;Edwina Anyango ,&nbsp;Samson Thuo ,&nbsp;Wycliffe Matini ,&nbsp;Harriet Mirieri ,&nbsp;Nancy Otieno ,&nbsp;Mwanasha Athman ,&nbsp;Patrick Chanzera ,&nbsp;Zahra Awadh ,&nbsp;Jeanette Dawa","doi":"10.1016/j.jvacx.2024.100507","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100507","url":null,"abstract":"<div><h3>Background</h3><p>Influenza is a significant contributor to acute respiratory infections (ARI), and children &lt; 5 years are at increased risk of severe influenza disease. In Kenya the influenza vaccine is not included in the Kenya Expanded Programme on Immunization (KEPI). To inform roll-out of a national influenza vaccination program, we implemented an influenza vaccine demonstration project in Nakuru and Mombasa counties in Kenya from 2019 to 2021 and set out to establish factors driving influenza vaccine acceptance and hesitancy among caregivers of children aged 6–23 months.</p></div><div><h3>Methods</h3><p>Using semi-structured questionnaires, we conducted eight focus group discussions among community members and twelve key informant interviews among healthcare workers to elicit both lay and expert opinions. Thematic analysis of the interviews was conducted using the World Health Organization’s “3 Cs” model of vaccine hesitancy to determine reasons for acceptance or hesitancy of the influenza vaccine.</p></div><div><h3>Results</h3><p>The influenza vaccine was well received among community members and healthcare workers though concerns were raised. Vaccine hesitancy was fuelled by misconceptions about reasons for introducing the vaccine (confidence), perceptions that influenza was not a serious disease (complacency) and administrative fees required at some facilities (convenience). Despite the use of various advocacy, communication and social mobilisation strategies targeted at educating the community on the influenza disease and importance of vaccination, there remained a perception of inadequate reach of the sensitization among some community members. Contextual factors such as the COVID-19 pandemic affected uptake, and parents expressed concern over the growing number of vaccines recommended for children.</p></div><div><h3>Conclusion</h3><p>Despite lingering concerns, caregivers had their children vaccinated indicating that vaccine hesitancy exists, even among those who accepted the vaccine for their children. Efforts targeted at increasing confidence in and reducing misconceptions towards vaccines through effective communication strategies, are likely to lead to increased vaccine uptake.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100507"},"PeriodicalIF":3.8,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000809/pdfft?md5=a2fb401bb8fb02483a355422439fe037&pid=1-s2.0-S2590136224000809-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141242237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the immunoprotective power of a multiple antigenic peptide against Aah II toxin of Androctonus australis hector scorpion","authors":"Safouane M. Benazzouz ,&nbsp;Nesrine Benlouahmia ,&nbsp;Karima Bouhadida ,&nbsp;Meriem Benlamara ,&nbsp;Naziha Arezki ,&nbsp;Oum El Kheir Sadeddine ,&nbsp;Mourad Issad ,&nbsp;Nabila Attal ,&nbsp;Kamel Mansouri ,&nbsp;Fawzi Derrar ,&nbsp;Reda Djidjik","doi":"10.1016/j.jvacx.2024.100503","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100503","url":null,"abstract":"<div><p>Scorpion envenoming (SE) is a public health problem in developing countries. In Algeria, the population exposed to the risk of SE was estimated at 86.45% in 2019. Thus, the development of a vaccine to protect the exposed population against scorpion toxins would be a major advance in the fight against this disease.</p><p>This work aimed to evaluate the immunoprotective effect of a Multiple Antigenic Peptide against the Aah II toxin of <em>Androctonus australis hector</em> scorpion, the most dangerous scorpion species in Algeria. The immunogen MAP1Aah2 was designed and tested accordingly. This molecule contains a B epitope, derived from Aah II toxin, linked by a spacer to a universal T epitope, derived from the tetanus toxin.</p><p>The results showed that MAP1Aah2 was non-toxic despite the fact that its sequence was derived from Aah II toxin. The immunoenzymatic assay revealed that the 3 immunization regimens tested generated specific anti-MAP1Aah2 antibodies and cross-reacted with the toxin. Mice immunized with this immunogen were partially protected against mortality caused by challenge doses of 2 and 3 LD₅₀ of the toxin. The survival rate and developed symptoms varied depending on the adjuvant and the challenge dose used. In the <em>in vitro</em> neutralization test, the immune sera of mice having received the immunogen with incomplete Freund’s adjuvant neutralized a challenge dose of 2 LD50.</p><p>Hence, the concept of using peptide dendrimers, based on linear epitopes of scorpion toxins, as immunogens against the parent toxin was established. However, the protective properties of the tested immunogen require further optimizations.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100503"},"PeriodicalIF":3.8,"publicationDate":"2024-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000767/pdfft?md5=6a7b013064e9236a44f8ca76a790d56d&pid=1-s2.0-S2590136224000767-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141242236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vaccine delivery systems and administration routes: Advanced biotechnological techniques to improve the immunization efficacy","authors":"Abdellatif Bouazzaoui ,&nbsp;Ahmed A.H. Abdellatif","doi":"10.1016/j.jvacx.2024.100500","DOIUrl":"10.1016/j.jvacx.2024.100500","url":null,"abstract":"<div><p>Since the first use of vaccine tell the last COVID-19 pandemic caused by spread of SARS-CoV-2 worldwide, the use of advanced biotechnological techniques has accelerated the development of different types and methods for immunization. The last pandemic showed that the nucleic acid-based vaccine, especially mRNA, has an advantage in terms of development time; however, it showed a very critical drawback namely, the higher costs when compared to other strategies, and its inability to protect against new variants. This showed the need of more improvement to reach a better delivery and efficacy. In this review we will describe different vaccine delivery systems including, the most used viral vector, and also variable strategies for delivering of nucleic acid-based vaccines especially lipid-based nanoparticles formulation, polymersomes, electroporation and also the new powerful tools for the delivery of mRNA, which is based on the use of cell-penetrating peptides (CPPs). Additionally, we will also discuss the main challenges associated with each system. Finlay, the efficacy and safety of the vaccines depends not only on the formulations and delivery systems, but also the dosage and route of administration are also important players, therefore we will see the different routes for the vaccine administration including traditionally routes (intramuscular, Transdermal, subcutaneous), oral inhalation or via nasal mucosa, and will describe the advantages and disadvantage of each administration route.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100500"},"PeriodicalIF":3.8,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000731/pdfft?md5=7888f0c6fffc2817470660bc86c5b072&pid=1-s2.0-S2590136224000731-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141142967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Title: Accelerating sustainable regional vaccine manufacturing through global partnerships – 24th DCVMN Annual General meeting 2023 report","authors":"Rajinder Kumar Suri ,&nbsp;Aila Marini","doi":"10.1016/j.jvacx.2024.100504","DOIUrl":"10.1016/j.jvacx.2024.100504","url":null,"abstract":"<div><p>The 24th Annual General Meeting of the Developing Countries Vaccine Manufacturers’ Network (DCVMN), held in Cape Town, South Africa and co-hosted by Biovac, convened over 400 delegates and featured more than 100 distinguished speakers across three days. This gathering served as a vital platform for vaccine manufacturers from developing nations to share insights, challenges, and achievements, underscoring their pivotal role in global vaccine research, development, and distribution to promote vaccine equity. The conference theme centered on partnerships in various forms and their instrumental role in assisting local manufacturers in achieving their and global health objectives. Speakers provided comprehensive reviews of the vaccine industry’s current landscape, covering aspects such as development, manufacturing, quality control, technology transfer, and gender-related immunization, with a focus on the perspectives of DCVMs. This paper focuses on these interconnected areas, examining their present status through the perspectives of our member manufacturers and prominent global health organizations.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100504"},"PeriodicalIF":3.8,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000779/pdfft?md5=a04423c49a7c078753b8ef9d2f7ba593&pid=1-s2.0-S2590136224000779-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141144773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digitizing tools for post introduction evaluation of rotavirus vaccine introduction in India","authors":"Pawan Kumar ,&nbsp;Amanjot Kaur ,&nbsp;Arindam Ray ,&nbsp;Kapil Singh ,&nbsp;Shipra Verma ,&nbsp;Rhythm Hora ,&nbsp;Seema S Koshal ,&nbsp;Amrita Kumari ,&nbsp;Rashmi Mehra ,&nbsp;Syed F Quadri ,&nbsp;Arup Deb Roy","doi":"10.1016/j.jvacx.2024.100502","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100502","url":null,"abstract":"<div><h3>Background and aims</h3><p>The Rotavirus vaccine (RVV) introduction is a landmark event in the history of Indian public health as for the first time a novel, low-cost indigenous vaccine was introduced in a short timeline between 2016 and 2019. As per WHO mandate, post-introduction evaluation (PIE) be conducted within 6 to 12 months of vaccine introduction to provide an understanding of the operational aspects of the program. For RVV PIE, an innovative approach to developing and deploying a digitized tool was employed. The present study aims to document the processes followed for digitizing the data collection and analysis tools.</p></div><div><h3>Methods</h3><p>The development of the RVV-PIE digital tool was undertaken in two phases. In the first phase, conceptualization and iteration of the modified WHO PIE tool were undertaken. Questions were organized sequentially to ensure natural progression in responses. The finalized questionnaire was converted to a digital version and extensive dummy data was entered to improve automated qualitative data analysis. Phase 2 involved updating the draft tool and incorporating changes to provide a field-tested version for deployment.</p></div><div><h3>Results</h3><p>The digital version of the tool was successfully developed. The GPS functionality of the tool allowed live tracking of data collection making the process more accountable. The tool was prepopulated with reference materials and data points for easy reference and retrieval by the evaluators. The digitization of the tool also allowed easy visualization of data through maps, charts, and graphs on a real-time user-friendly dashboard.</p></div><div><h3>Conclusions</h3><p>The digitization of the PIE tool for RVV in India has been a great learning experience where the dire situation of an ongoing pandemic catapulted us towards a more efficient and comprehensive process innovation. The RVV PIE tool could serve as a customizable digital PIE tool for other health programs heralding an era of a more effective and proficient process of PIE.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100502"},"PeriodicalIF":3.8,"publicationDate":"2024-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000755/pdfft?md5=4213c22b8270bb33c4b017b4dfe6a4df&pid=1-s2.0-S2590136224000755-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141095081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comirnaty-induced cardiopulmonary distress and other symptoms of complement-mediated pseudo-anaphylaxis in a hyperimmune pig model: Causal role of anti-PEG antibodies","authors":"Bálint András Barta ,&nbsp;Tamás Radovits ,&nbsp;Attila Balázs Dobos ,&nbsp;Gergely Tibor Kozma ,&nbsp;Tamás Mészáros ,&nbsp;Petra Berényi ,&nbsp;Réka Facskó ,&nbsp;Tamás Fülöp ,&nbsp;Béla Merkely ,&nbsp;János Szebeni","doi":"10.1016/j.jvacx.2024.100497","DOIUrl":"10.1016/j.jvacx.2024.100497","url":null,"abstract":"<div><h3>Background</h3><p>Comirnaty, Pfizer-BioNTech's polyethylene-glycol (PEG)-containing Covid-19 vaccine, can cause hypersensitivity reactions (HSRs), or rarely, life-threatening anaphylaxis in a small fraction of immunized people. A causal role of anti-PEG antibodies (Abs) has been proposed, but causality has not yet proven in an animal model. The aim of this study was to provide such evidence using pigs immunized against PEG, which displayed very high levels of anti-PEG antibodies (Abs). We also aimed to find evidence for a role of complement activation and thromboxane A2 release in blood to explore the mechanism of anaphylaxis.</p></div><div><h3>Methods</h3><p>Pigs (n = 6) were immunized with 0.1 mg/kg PEGylated liposome (Doxebo) i.v., and the rise of anti-PEG IgG and IgM were measured in serial blood samples with ELISA. After ∼2–3 weeks the animals were injected i.v. with 1/3 human dose of the PEGylated mRNA vaccine, Comirnaty, and the hemodynamic (PAP, SAP) cardiopulmonary (HR, EtCO2,), hematological (WBC, granulocyte, lymphocyte and platelet counts) parameters and blood immune mediators (anti-PEG IgM and IgG antibodies, thromboxane B2, C3a) were measured as endpoints of HSRs (anaphylaxis).</p></div><div><h3>Results</h3><p>The level of anti-PEG IgM and IgG rose 5–10-thousand-fold in all of 6 pigs immunized with Doxebo by day 6, after which time all animals developed anaphylactic shock to i.v. injection of 1/3 human dose of Comirnaty. The reaction, starting within 1 min involved maximal pulmonary hypertension and decreased systemic pulse pressure amplitude, tachycardia, granulo- and thrombocytopenia, and skin reactions (flushing or rash). These physiological changes or their absence were paralleled by C3a and TXB2 rises in blood.</p></div><div><h3>Conclusions</h3><p>Consistent with previous studies, these data show a causal role of anti-PEG Abs in the anaphylaxis to Comirnaty, which involves complement activation, and, hence, it represents C activation-related pseudo-anaphylaxis. The setup provides the first large-animal model for mRNA-vaccine-induced anaphylaxis in humans.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100497"},"PeriodicalIF":3.8,"publicationDate":"2024-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000706/pdfft?md5=e2c12c670a7f0529e00aae6ec791d077&pid=1-s2.0-S2590136224000706-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141145112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}