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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
Vaccine Pub Date : 2025-01-12 Epub Date: 2023-06-14 DOI: 10.1016/j.vaccine.2023.06.030
Richard Muwonge, Partha Basu
{"title":"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.","authors":"Richard Muwonge, Partha Basu","doi":"10.1016/j.vaccine.2023.06.030","DOIUrl":"10.1016/j.vaccine.2023.06.030","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":" ","pages":"125062"},"PeriodicalIF":4.5,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9634998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessing human B cell responses to influenza virus vaccines and adjuvants in a PBMC-derived in vitro culture system
IF 4.5 3区 医学
Vaccine Pub Date : 2024-12-02 DOI: 10.1016/j.vaccine.2024.126563
Shuran Gong, Martin Beukema, Jacqueline De Vries-Idema, Anke Huckriede
{"title":"Assessing human B cell responses to influenza virus vaccines and adjuvants in a PBMC-derived in vitro culture system","authors":"Shuran Gong,&nbsp;Martin Beukema,&nbsp;Jacqueline De Vries-Idema,&nbsp;Anke Huckriede","doi":"10.1016/j.vaccine.2024.126563","DOIUrl":"10.1016/j.vaccine.2024.126563","url":null,"abstract":"<div><div><em>In vitro</em> 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, <em>PRDM1, XBP1,</em> and <em>AICDA</em>, 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.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126563"},"PeriodicalIF":4.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142758846","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
The stability of PCV2 virus-like particles from mammalian cells and challenges for biotechnological applications
IF 4.5 3区 医学
Vaccine 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
{"title":"The stability of PCV2 virus-like particles from mammalian cells and challenges for biotechnological applications","authors":"Natalia Olivero-Deibe ,&nbsp;Ezequiel N. Frigini ,&nbsp;Natalia Ramos ,&nbsp;Federico Carrión ,&nbsp;Florencia Fadel ,&nbsp;Lihuén Villarreal ,&nbsp;Juan C. Benech ,&nbsp;Juan Arbiza ,&nbsp;Sergio Pantano ,&nbsp;Claudia Ortega","doi":"10.1016/j.vaccine.2024.126549","DOIUrl":"10.1016/j.vaccine.2024.126549","url":null,"abstract":"<div><div>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.</div><div>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.</div><div>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.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126549"},"PeriodicalIF":4.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142758845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exploring Chatbot contributions to enhancing vaccine literacy and uptake: A scoping review of the literature
IF 4.5 3区 医学
Vaccine 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
{"title":"Exploring Chatbot contributions to enhancing vaccine literacy and uptake: A scoping review of the literature","authors":"Claudia Cosma ,&nbsp;Alessio Radi ,&nbsp;Rachele Cattano ,&nbsp;Patrizio Zanobini ,&nbsp;Guglielmo Bonaccorsi ,&nbsp;Chiara Lorini ,&nbsp;Marco Del Riccio","doi":"10.1016/j.vaccine.2024.126559","DOIUrl":"10.1016/j.vaccine.2024.126559","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>These digital assistants could provide personalized and up-to-date information, improving not only knowledge but also attitudes and intentions towards vaccinations.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126559"},"PeriodicalIF":4.5,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142746145","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
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.
IF 4.5 3区 医学
Vaccine 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
{"title":"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.","authors":"Ponesai Nyika,&nbsp;David Yankey,&nbsp;Laurie D. Elam-Evans,&nbsp;S. Meyer,&nbsp;C. Pingali,&nbsp;Shannon Stokley,&nbsp;James A. Singleton","doi":"10.1016/j.vaccine.2024.126560","DOIUrl":"10.1016/j.vaccine.2024.126560","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate human papillomavirus (HPV) vaccination coverage among adolescents in the U.S. using birth cohort analysis.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126560"},"PeriodicalIF":4.5,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142746190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The effectiveness of vaccines against COVID-19 in Mexico: A time series approach
IF 4.5 3区 医学
Vaccine Pub Date : 2024-11-30 DOI: 10.1016/j.vaccine.2024.126565
D. Flores, E.M. Luna
{"title":"The effectiveness of vaccines against COVID-19 in Mexico: A time series approach","authors":"D. Flores,&nbsp;E.M. Luna","doi":"10.1016/j.vaccine.2024.126565","DOIUrl":"10.1016/j.vaccine.2024.126565","url":null,"abstract":"<div><h3>Objective</h3><div>To estimate the effectiveness of several vaccine brands—Pfizer, Astra, and Sinovac—against symptomatic COVID-19 without information on vaccination at the individual level.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126565"},"PeriodicalIF":4.5,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142745659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Respiratory syncytial virus (RSV) prevention: Perception and willingness of expectant parents in the Netherlands
IF 4.5 3区 医学
Vaccine 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
{"title":"Respiratory syncytial virus (RSV) prevention: Perception and willingness of expectant parents in the Netherlands","authors":"Lisette M. Harteveld ,&nbsp;Lisanne M. van Leeuwen ,&nbsp;Sjoerd M. Euser ,&nbsp;Lucy J. Smit ,&nbsp;Karlijn C. Vollebregt ,&nbsp;Debby Bogaert ,&nbsp;Marlies A. van Houten","doi":"10.1016/j.vaccine.2024.126541","DOIUrl":"10.1016/j.vaccine.2024.126541","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126541"},"PeriodicalIF":4.5,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142746191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The evidence base for rotavirus vaccination in India: Current status, future needs
IF 4.5 3区 医学
Vaccine 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
{"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
IF 4.5 3区 医学
Vaccine 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
{"title":"Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: A randomised, comparator-controlled, phase 2 trial","authors":"Vu Dinh Thiem ,&nbsp;Dang Duc Anh ,&nbsp;Vu Hai Ha ,&nbsp;Nguyen Van Thom ,&nbsp;Tran Cong Thang ,&nbsp;Jose Mateus ,&nbsp;Juan Manuel Carreño ,&nbsp;Rama Raghunandan ,&nbsp;Nguyen Mai Huong ,&nbsp;Laina D. Mercer ,&nbsp;Jorge Flores ,&nbsp;E. Alexandar Escarrega ,&nbsp;Ariel Raskin ,&nbsp;Duong Huu Thai ,&nbsp;Le Van Be ,&nbsp;Alessandro Sette ,&nbsp;Bruce L. Innis ,&nbsp;Florian Krammer ,&nbsp;Daniela Weiskopf","doi":"10.1016/j.vaccine.2024.126542","DOIUrl":"10.1016/j.vaccine.2024.126542","url":null,"abstract":"&lt;div&gt;&lt;div&gt;Abstract&lt;/div&gt;&lt;div&gt;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.&lt;/div&gt;&lt;div&gt;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.&lt;/div&gt;&lt;div&gt;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. &lt;span&gt;&lt;span&gt;ClinicalTrials.gov&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; &lt;span&gt;&lt;span&gt;NCT05940194&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;.&lt;/div&gt;&lt;div&gt;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.&lt;/div&gt;&lt;div&gt;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 &lt;em&gt;N&lt;/em&gt; = 82, 95 % CI 25·14–38·74), 35·80 (COVIVAC 6 μg; &lt;em&gt;N&lt;/em&gt; = 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; &lt;em&gt;N&lt;/em&gt; = 42, 95 % CI 27·43–50·63), 50·10 (COVIVAC 6 μg; &lt;em&gt;N&lt;/em&gt; = 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","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126542"},"PeriodicalIF":4.5,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142746192","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
Addressing vaccine misinformation: The critical need for complete product information disclosure
IF 4.5 3区 医学
Vaccine Pub Date : 2024-11-29 DOI: 10.1016/j.vaccine.2024.126558
Peter J. Pitts , Gregory A. Poland
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