Pub Date : 2024-12-31Epub Date: 2024-05-23DOI: 10.1080/21645515.2024.2350817
Narmeen Mallah, Jacobo Pardo-Seco, Irene Rivero-Calle, Ouhao Zhu-Huang, María Fernández Prada, Catharina Reynen-de Kat, Oleg Benes, Liudmila Mosina, Siddhartha Sankar-Datta, Olga Aleksinskaya, David Díaz, Vusala Allahverdiyeva, Yevgenii Grechukha, Tamara Jobava, Mariia Savchyna, Pavla Kortusova, Ioana Novac, Federico Martinón-Torres
COVID-19 vaccine uptake varied across countries, in part due to vaccine hesitancy fueled by a lack of trustworthy information. To help health workers provide evidence-based answers to common questions about COVID-19 vaccines and vaccination, and thereby, assist individuals´ decisions on vaccine acceptance, COVID-19 InfoVaccines, a joint WHO-EU project, was launched in February 2021 to support COVID-19 vaccine rollout in 6 Eastern European countries. COVID-19 InfoVaccines was made available in seven languages and shared on social media networks. A total of 262,592 users accessed COVID-19 InfoVaccines.com between February 11, 2021, and January 31st, 2023. The users were most interested in: general questions; vaccine efficacy and duration of protection; vaccine safety; vaccine co-administration, and dose-interval and interchangeability; though the interest in a specific theme varied in function of the epidemiological situation. A total of 118,510 (45.1%) and 46,644 (17.7%) users scrolled up to 35% and 75% of the COVID-19 InfoVaccines webpage, respectively. The average engagement rate was 71.61%. The users accessed COVID-19 InfoVaccines from 231 countries and territories, but the majority were in Ukraine (N = 38,404; 14.6%), Spain (N = 23,327; 8.9%), and Argentina (N = 21,167; 8.1%). Older Facebook users were more interested in COVID-19 information than younger individuals (X2 p-value < .0001). Two hundred twenty-eight videos were shared on YouTube. The average Click-Through-Rate on Facebook was 7.82%, and that on YouTube was 4.4%, with 60 videos having a Click-Through-Rate >5%, falling in the range of average YouTube video Click-Through-Rate (2% - 10%). As misinformation about vaccines and vaccination spreads easily and can negatively impact health-related decisions, initiatives like COVID-19 InfoVaccines are crucial to facilitate access to reliable information.
{"title":"COVID-19 InfoVaccines: A WHO-supported educational project to promote COVID-19 vaccination information among professionals and the general population.","authors":"Narmeen Mallah, Jacobo Pardo-Seco, Irene Rivero-Calle, Ouhao Zhu-Huang, María Fernández Prada, Catharina Reynen-de Kat, Oleg Benes, Liudmila Mosina, Siddhartha Sankar-Datta, Olga Aleksinskaya, David Díaz, Vusala Allahverdiyeva, Yevgenii Grechukha, Tamara Jobava, Mariia Savchyna, Pavla Kortusova, Ioana Novac, Federico Martinón-Torres","doi":"10.1080/21645515.2024.2350817","DOIUrl":"10.1080/21645515.2024.2350817","url":null,"abstract":"<p><p>COVID-19 vaccine uptake varied across countries, in part due to vaccine hesitancy fueled by a lack of trustworthy information. To help health workers provide evidence-based answers to common questions about COVID-19 vaccines and vaccination, and thereby, assist individuals´ decisions on vaccine acceptance, COVID-19 InfoVaccines, a joint WHO-EU project, was launched in February 2021 to support COVID-19 vaccine rollout in 6 Eastern European countries. COVID-19 InfoVaccines was made available in seven languages and shared on social media networks. A total of 262,592 users accessed COVID-19 InfoVaccines.com between February 11, 2021, and January 31<sup>st</sup>, 2023. The users were most interested in: general questions; vaccine efficacy and duration of protection; vaccine safety; vaccine co-administration, and dose-interval and interchangeability; though the interest in a specific theme varied in function of the epidemiological situation. A total of 118,510 (45.1%) and 46,644 (17.7%) users scrolled up to 35% and 75% of the COVID-19 InfoVaccines webpage, respectively. The average engagement rate was 71.61%. The users accessed COVID-19 InfoVaccines from 231 countries and territories, but the majority were in Ukraine (<i>N</i> = 38,404; 14.6%), Spain (<i>N</i> = 23,327; 8.9%), and Argentina (<i>N</i> = 21,167; 8.1%). Older Facebook users were more interested in COVID-19 information than younger individuals (<i>X</i><sup><i>2</i></sup> p-value < .0001). Two hundred twenty-eight videos were shared on YouTube. The average Click-Through-Rate on Facebook was 7.82%, and that on YouTube was 4.4%, with 60 videos having a Click-Through-Rate >5%, falling in the range of average YouTube video Click-Through-Rate (2% - 10%). As misinformation about vaccines and vaccination spreads easily and can negatively impact health-related decisions, initiatives like COVID-19 InfoVaccines are crucial to facilitate access to reliable information.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11123498/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141089160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31Epub Date: 2024-06-07DOI: 10.1080/21645515.2024.2361946
Casey E Parker, Anne M Hause, Paige Marquez, Bicheng Zhang, Tanya R Myers, David K Shay
Introduction COVID-19 vaccines may be administered with other vaccines during the same healthcare visit. COVID-19 monovalent (Fall 2021) and bivalent (Fall 2022) vaccine recommendations coincided with annual seasonal influenza vaccination. Data describing the frequency of the co-administration of COVID-19 vaccines with other vaccines are limited. Methods We used V-safe, a voluntary smartphone-based U.S. safety surveillance system established by the CDC, to describe trends in the administration of COVID-19 vaccines with other vaccines reported to V-safe during December 14, 2020 - May 19, 2023. Results Of the 21 million COVID-19 vaccinations reported to V-safe, 2.2% (459,817) were administered with at least 1 other vaccine. Co-administration most frequently occurred during the first week of October 2023 (27,092; 44.1%). Most reports of co-administration included influenza vaccine (393,003; 85.5%). Co-administration was most frequently reported for registrants aged 6 months-6 years (4,872; 4.4%). Conclusion Reports of co-administration to V-safe peaked during October 2023, when influenza vaccination most often occurs, possibly reflecting increased opportunities for multiple vaccinations and greater acceptability of the co-administration of COVID-19 vaccine with other vaccines, especially influenza vaccine.
{"title":"Trends in the administration of COVID-19 vaccines with other vaccines in the United States reported to V-safe during December 14, 2020-May 19, 2023.","authors":"Casey E Parker, Anne M Hause, Paige Marquez, Bicheng Zhang, Tanya R Myers, David K Shay","doi":"10.1080/21645515.2024.2361946","DOIUrl":"10.1080/21645515.2024.2361946","url":null,"abstract":"<p><p>Introduction COVID-19 vaccines may be administered with other vaccines during the same healthcare visit. COVID-19 monovalent (Fall 2021) and bivalent (Fall 2022) vaccine recommendations coincided with annual seasonal influenza vaccination. Data describing the frequency of the co-administration of COVID-19 vaccines with other vaccines are limited. Methods We used V-safe, a voluntary smartphone-based U.S. safety surveillance system established by the CDC, to describe trends in the administration of COVID-19 vaccines with other vaccines reported to V-safe during December 14, 2020 - May 19, 2023. Results Of the 21 million COVID-19 vaccinations reported to V-safe, 2.2% (459,817) were administered with at least 1 other vaccine. Co-administration most frequently occurred during the first week of October 2023 (27,092; 44.1%). Most reports of co-administration included influenza vaccine (393,003; 85.5%). Co-administration was most frequently reported for registrants aged 6 months-6 years (4,872; 4.4%). Conclusion Reports of co-administration to V-safe peaked during October 2023, when influenza vaccination most often occurs, possibly reflecting increased opportunities for multiple vaccinations and greater acceptability of the co-administration of COVID-19 vaccine with other vaccines, especially influenza vaccine.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11164217/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141285095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This study assessed the knowledge of 12- to 15-year-old male junior high school students of HPV and HPV vaccines and their willingness to be vaccinated against it. From March to May 2023, students from six junior high schools in Zhejiang Province were randomly selected to complete an online, anonymous, self-administered questionnaire. Of the 1786 students, 618 (34.6%) reported knowledge of HPV vaccine. In general, junior high school boys have low general knowledge about HPV, the consequences of HPV infection, and the effects of HPV vaccination. Multivariate analysis showed that the subgroup scoring 6-7 on the measure of the consequences of HPV infection(7 questions with 1 score for each correct answer) compared to the subgroup scoring 0, the subgroups scoring 2 and 3 on the measure of the preventive effect of HPV vaccine(3 questions with 1 score for each correct answer) compared to the subgroup scoring 0 were were more likely to be willing to be vaccinated against HPV. Hearing that someone close to them had cancer, believing that men also need to be vaccinated against HPV, knowing that someone close to them had been vaccinated against HPV, and being concerned about cervical cancer in their female sexual partners were all more likely to generate positive responses. HPV vaccine education for this group of students should emphasize the possibility and consequences of HPV infection in males, along with the importance and benefits of HPV vaccination; actual cases of vaccination in students around them can be used to achieve this goal.
{"title":"Knowledge, awareness, and correlates of HPV vaccine acceptability among male junior high school students in Zhejiang Province, China.","authors":"Xiang Zhao, Yu Huang, Qiaohong Lv, Lei Wang, Suxian Wu, Qingqing Wu","doi":"10.1080/21645515.2024.2357238","DOIUrl":"10.1080/21645515.2024.2357238","url":null,"abstract":"<p><p>This study assessed the knowledge of 12- to 15-year-old male junior high school students of HPV and HPV vaccines and their willingness to be vaccinated against it. From March to May 2023, students from six junior high schools in Zhejiang Province were randomly selected to complete an online, anonymous, self-administered questionnaire. Of the 1786 students, 618 (34.6%) reported knowledge of HPV vaccine. In general, junior high school boys have low general knowledge about HPV, the consequences of HPV infection, and the effects of HPV vaccination. Multivariate analysis showed that the subgroup scoring 6-7 on the measure of the consequences of HPV infection(7 questions with 1 score for each correct answer) compared to the subgroup scoring 0, the subgroups scoring 2 and 3 on the measure of the preventive effect of HPV vaccine(3 questions with 1 score for each correct answer) compared to the subgroup scoring 0 were were more likely to be willing to be vaccinated against HPV. Hearing that someone close to them had cancer, believing that men also need to be vaccinated against HPV, knowing that someone close to them had been vaccinated against HPV, and being concerned about cervical cancer in their female sexual partners were all more likely to generate positive responses. HPV vaccine education for this group of students should emphasize the possibility and consequences of HPV infection in males, along with the importance and benefits of HPV vaccination; actual cases of vaccination in students around them can be used to achieve this goal.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11178271/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141312105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31Epub Date: 2024-06-02DOI: 10.1080/21645515.2024.2356269
Hua Shi, Xiaojian Zhang, Pan Ge, Victoria Meliopoulos, Pam Freiden, Brandi Livingston, Stacey Schultz-Cherry, Ted M Ross
The influenza viruses cause seasonal respiratory illness that affect millions of people globally every year. Prophylactic vaccines are the recommended method to prevent the breakout of influenza epidemics. One of the current commercial influenza vaccines consists of inactivated viruses that are selected months prior to the start of a new influenza season. In many seasons, the vaccine effectiveness (VE) of these vaccines can be relatively low. Therefore, there is an urgent need to develop an improved, more universal influenza vaccine (UIV) that can provide broad protection against various drifted strains in all age groups. To meet this need, the computationally optimized broadly reactive antigen (COBRA) methodology was developed to design a hemagglutinin (HA) molecule as a new influenza vaccine. In this study, COBRA HA-based inactivated influenza viruses (IIV) expressing the COBRA HA from H1 or H3 influenza viruses were developed and characterized for the elicitation of immediate and long-term protective immunity in both immunologically naïve or influenza pre-immune animal models. These results were compared to animals vaccinated with IIV vaccines expressing wild-type H1 or H3 HA proteins (WT-IIV). The COBRA-IIV elicited long-lasting broadly reactive antibodies that had hemagglutination-inhibition (HAI) activity against drifted influenza variants.
流感病毒导致季节性呼吸道疾病,每年影响全球数百万人。预防性疫苗是防止流感流行的推荐方法。目前的一种商用流感疫苗由灭活病毒组成,在新流感季节开始前几个月进行挑选。在许多季节中,这些疫苗的有效性(VE)可能相对较低。因此,迫切需要开发一种改进的、更通用的流感疫苗 (UIV),为所有年龄组的人提供广泛的保护,以抵御各种漂移毒株。为了满足这一需求,我们开发了计算优化广泛反应抗原(COBRA)方法来设计一种血凝素(HA)分子作为新型流感疫苗。本研究开发了基于 COBRA HA 的灭活流感病毒 (IIV),该病毒表达了来自 H1 或 H3 流感病毒的 COBRA HA,并在免疫幼稚动物模型或流感免疫前动物模型中激发了即刻和长期的保护性免疫。这些结果与接种了表达野生型 H1 或 H3 HA 蛋白(WT-IIV)的 IIV 疫苗的动物进行了比较。COBRA-IIV 能激发持久的广泛反应性抗体,对流感病毒的变种具有血凝抑制(HAI)活性。
{"title":"Inactivated influenza virus vaccines expressing COBRA hemagglutinin elicited broadly reactive, long-lived protective antibodies.","authors":"Hua Shi, Xiaojian Zhang, Pan Ge, Victoria Meliopoulos, Pam Freiden, Brandi Livingston, Stacey Schultz-Cherry, Ted M Ross","doi":"10.1080/21645515.2024.2356269","DOIUrl":"10.1080/21645515.2024.2356269","url":null,"abstract":"<p><p>The influenza viruses cause seasonal respiratory illness that affect millions of people globally every year. Prophylactic vaccines are the recommended method to prevent the breakout of influenza epidemics. One of the current commercial influenza vaccines consists of inactivated viruses that are selected months prior to the start of a new influenza season. In many seasons, the vaccine effectiveness (VE) of these vaccines can be relatively low. Therefore, there is an urgent need to develop an improved, more universal influenza vaccine (UIV) that can provide broad protection against various drifted strains in all age groups. To meet this need, the computationally optimized broadly reactive antigen (COBRA) methodology was developed to design a hemagglutinin (HA) molecule as a new influenza vaccine. In this study, COBRA HA-based inactivated influenza viruses (IIV) expressing the COBRA HA from H1 or H3 influenza viruses were developed and characterized for the elicitation of immediate and long-term protective immunity in both immunologically naïve or influenza pre-immune animal models. These results were compared to animals vaccinated with IIV vaccines expressing wild-type H1 or H3 HA proteins (WT-IIV). The COBRA-IIV elicited long-lasting broadly reactive antibodies that had hemagglutination-inhibition (HAI) activity against drifted influenza variants.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11152115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141200995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31Epub Date: 2024-05-20DOI: 10.1080/21645515.2024.2344983
Jing Chen, Page E Abrahamson, Yu Ke, Chin Rong Ong, Raunak Parikh, Sumitra Shantakumar
Herpes zoster (HZ) is a painful rash which typically affects older adults. This is of concern in Asia-Pacific given its aging population. As HZ epidemiology and burden are evolving, this systematic literature review aimed to update the current understanding of HZ burden and associated costs for selected Asia-Pacific locales. MEDLINE and Embase were searched for English articles of HZ studies conducted in Australia, China, Hong Kong, Japan, Korea, New Zealand, Singapore, and Taiwan. Eligible outcomes included HZ incidence and prevalence, occurrence of HZ-related complications, healthcare resource utilization, costs, and HZ-associated quality of life outcomes. This paper focused on HZ data in the general adult population (N = 90 articles). Substantial HZ-related disease and economic burden were observed in these locales, consistent with global trends. These findings reinforce the increasing burden of HZ and need for preventive strategies, which may include raising awareness and encouraging timely vaccination.
{"title":"A systematic literature review of the epidemiology and burden of herpes zoster in selected locales in Asia Pacific.","authors":"Jing Chen, Page E Abrahamson, Yu Ke, Chin Rong Ong, Raunak Parikh, Sumitra Shantakumar","doi":"10.1080/21645515.2024.2344983","DOIUrl":"10.1080/21645515.2024.2344983","url":null,"abstract":"<p><p>Herpes zoster (HZ) is a painful rash which typically affects older adults. This is of concern in Asia-Pacific given its aging population. As HZ epidemiology and burden are evolving, this systematic literature review aimed to update the current understanding of HZ burden and associated costs for selected Asia-Pacific locales. MEDLINE and Embase were searched for English articles of HZ studies conducted in Australia, China, Hong Kong, Japan, Korea, New Zealand, Singapore, and Taiwan. Eligible outcomes included HZ incidence and prevalence, occurrence of HZ-related complications, healthcare resource utilization, costs, and HZ-associated quality of life outcomes. This paper focused on HZ data in the general adult population (<i>N</i> = 90 articles). Substantial HZ-related disease and economic burden were observed in these locales, consistent with global trends. These findings reinforce the increasing burden of HZ and need for preventive strategies, which may include raising awareness and encouraging timely vaccination.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11110703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141066192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31Epub Date: 2024-05-23DOI: 10.1080/21645515.2024.2344970
Tessa Hosman, Roy van Heesbeen, Arangassery Rosemary Bastian, Weihong Hu, Christy Comeaux, Nynke Ligtenberg, Bart van Montfort, Benoît Callendret, Esther Heijnen
This study assessed three Ad26.RSV.preF/RSV preF protein combinations, combining different Ad26.RSV.preF doses and naturally aged preF protein, representing the expected critical vaccine quality attributes close to release, around intermediate shelf-life (ISL) and near-presumed end-of-shelf-life (EoSL), as a way to evaluate the vaccine immunogenicity and safety throughout its shelf-life. A single dose of Ad26.RSV.preF/RSV preF protein vaccine was administered to adults 60-75 years of age. Solicited adverse events (AEs), unsolicited AEs, and serious AEs (SAEs) were assessed for 7-day, 28-day, and 6-month periods after vaccination, respectively. RSV preF-binding antibody concentrations and RSV neutralizing titers were measured 14 days post-vaccination as primary and secondary endpoints, respectively; binding antibodies were also measured 6 months post-vaccination. The RSV preF-binding antibody responses induced by Ad26.RSV.preF/RSV preF protein vaccine lots representing the critical quality attributes around ISL and near presumed EoSL were noninferior to the responses induced by the vaccine lot representing the critical quality attributes near release. The RSV preF-binding and RSV neutralizing antibody levels measured 14 days post-vaccination were similar across the 3 groups. RSV preF-binding antibody concentrations were also similar 6 months post-vaccination. Solicited AEs were mostly mild to moderate in intensity, and a decreased reactogenicity was observed from the Release group to the ISL and EoSL group. None of the reported SAEs were considered related to study vaccination. The study provided evidence of sustained immunogenicity and safety over the intended shelf-life of the Ad26.RSV.pref/RSV preF protein vaccine. The three vaccine lots had acceptable safety profiles.
{"title":"Immunogenicity and safety of Ad26.RSV.preF/RSV preF protein vaccine at predicted intermediate- and end-of-shelf-life as an evaluation of potency throughout shelf life.","authors":"Tessa Hosman, Roy van Heesbeen, Arangassery Rosemary Bastian, Weihong Hu, Christy Comeaux, Nynke Ligtenberg, Bart van Montfort, Benoît Callendret, Esther Heijnen","doi":"10.1080/21645515.2024.2344970","DOIUrl":"10.1080/21645515.2024.2344970","url":null,"abstract":"<p><p>This study assessed three Ad26.RSV.preF/RSV preF protein combinations, combining different Ad26.RSV.preF doses and naturally aged preF protein, representing the expected critical vaccine quality attributes close to release, around intermediate shelf-life (ISL) and near-presumed end-of-shelf-life (EoSL), as a way to evaluate the vaccine immunogenicity and safety throughout its shelf-life. A single dose of Ad26.RSV.preF/RSV preF protein vaccine was administered to adults 60-75 years of age. Solicited adverse events (AEs), unsolicited AEs, and serious AEs (SAEs) were assessed for 7-day, 28-day, and 6-month periods after vaccination, respectively. RSV preF-binding antibody concentrations and RSV neutralizing titers were measured 14 days post-vaccination as primary and secondary endpoints, respectively; binding antibodies were also measured 6 months post-vaccination. The RSV preF-binding antibody responses induced by Ad26.RSV.preF/RSV preF protein vaccine lots representing the critical quality attributes around ISL and near presumed EoSL were noninferior to the responses induced by the vaccine lot representing the critical quality attributes near release. The RSV preF-binding and RSV neutralizing antibody levels measured 14 days post-vaccination were similar across the 3 groups. RSV preF-binding antibody concentrations were also similar 6 months post-vaccination. Solicited AEs were mostly mild to moderate in intensity, and a decreased reactogenicity was observed from the Release group to the ISL and EoSL group. None of the reported SAEs were considered related to study vaccination. The study provided evidence of sustained immunogenicity and safety over the intended shelf-life of the Ad26.RSV.pref/RSV preF protein vaccine. The three vaccine lots had acceptable safety profiles.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11135872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141089166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31Epub Date: 2024-05-09DOI: 10.1080/21645515.2024.2341505
Bryony Treston, Sarah Geoghegan
Respiratory Syncytial Virus poses a significant global public health threat, particularly affecting infants aged less than one year of age. Recently, two forms of passive immunization against infant RSV have been developed and brought to market; nirsevimab a long-acting monoclonal antibody (mAb) and RSV-PreF, a maternal RSV vaccine. The acceptability and uptake of these products will play a pivotal role in determining the success of any national immunization strategy aimed at safeguarding infants from RSV. It is crucial at this time to reflect on the factors that influence parental decisions surrounding immunization to facilitate more informed discussions, enhance healthcare communication, and contribute to the design of effective RSV prevention strategies that resonate with the concerns and aspirations of parents worldwide.
{"title":"Exploring parental perspectives: Maternal RSV vaccination versus infant RSV monoclonal antibody.","authors":"Bryony Treston, Sarah Geoghegan","doi":"10.1080/21645515.2024.2341505","DOIUrl":"10.1080/21645515.2024.2341505","url":null,"abstract":"<p><p>Respiratory Syncytial Virus poses a significant global public health threat, particularly affecting infants aged less than one year of age. Recently, two forms of passive immunization against infant RSV have been developed and brought to market; nirsevimab a long-acting monoclonal antibody (mAb) and RSV-PreF, a maternal RSV vaccine. The acceptability and uptake of these products will play a pivotal role in determining the success of any national immunization strategy aimed at safeguarding infants from RSV. It is crucial at this time to reflect on the factors that influence parental decisions surrounding immunization to facilitate more informed discussions, enhance healthcare communication, and contribute to the design of effective RSV prevention strategies that resonate with the concerns and aspirations of parents worldwide.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11085959/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140899695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Respiratory syncytial virus (RSV) is a highly contagious virus that affects the lungs and respiratory passages of many vulnerable people. It is a leading cause of lower respiratory tract infections and clinical complications, particularly among infants and elderly. It can develop into serious complications such as pneumonia and bronchiolitis. The development of RSV vaccine or immunoprophylaxis remains highly active and a global health priority. Currently, GSK's Arexvy™ vaccine is approved for the prevention of lower respiratory tract disease in older adults (>60 years). Palivizumab and currently nirsevimab are the approved monoclonal antibodies (mAbs) for RSV prevention in high-risk patients. Many studies are ongoing to develop additional therapeutic antibodies for preventing RSV infections among newborns and other susceptible groups. Recently, additional antibodies have been discovered and shown greater potential for development as therapeutic alternatives to palivizumab and nirsevimab. Plant expression platforms have proven successful in producing recombinant proteins, including antibodies, offering a potential cost-effective alternative to mammalian expression platforms. Hence in this study, an attempt was made to use a plant expression platform to produce two anti-RSV fusion (F) mAbs 5C4 and CR9501. The heavy-chain and light-chain sequences of both these antibodies were transiently expressed in Nicotiana benthamiana plants using a geminiviral vector and then purified using single-step protein A affinity column chromatography. Both these plant-produced mAbs showed specific binding to the RSV fusion protein and demonstrate effective viral neutralization activity in vitro. These preliminary findings suggest that plant-produced anti-RSV mAbs are able to neutralize RSV in vitro.
{"title":"Neutralizing activity of anti-respiratory syncytial virus monoclonal antibody produced in <i>Nicotiana benthamiana</i>.","authors":"Nuttapat Pisuttinusart, Kaewta Rattanapisit, Chanya Srisaowakarn, Arunee Thitithanyanont, Richard Strasser, Balamurugan Shanmugaraj, Waranyoo Phoolcharoen","doi":"10.1080/21645515.2024.2327142","DOIUrl":"10.1080/21645515.2024.2327142","url":null,"abstract":"<p><p>Respiratory syncytial virus (RSV) is a highly contagious virus that affects the lungs and respiratory passages of many vulnerable people. It is a leading cause of lower respiratory tract infections and clinical complications, particularly among infants and elderly. It can develop into serious complications such as pneumonia and bronchiolitis. The development of RSV vaccine or immunoprophylaxis remains highly active and a global health priority. Currently, GSK's Arexvy™ vaccine is approved for the prevention of lower respiratory tract disease in older adults (>60 years). Palivizumab and currently nirsevimab are the approved monoclonal antibodies (mAbs) for RSV prevention in high-risk patients. Many studies are ongoing to develop additional therapeutic antibodies for preventing RSV infections among newborns and other susceptible groups. Recently, additional antibodies have been discovered and shown greater potential for development as therapeutic alternatives to palivizumab and nirsevimab. Plant expression platforms have proven successful in producing recombinant proteins, including antibodies, offering a potential cost-effective alternative to mammalian expression platforms. Hence in this study, an attempt was made to use a plant expression platform to produce two anti-RSV fusion (F) mAbs 5C4 and CR9501. The heavy-chain and light-chain sequences of both these antibodies were transiently expressed in <i>Nicotiana benthamiana</i> plants using a geminiviral vector and then purified using single-step protein A affinity column chromatography. Both these plant-produced mAbs showed specific binding to the RSV fusion protein and demonstrate effective viral neutralization activity <i>in vitro</i>. These preliminary findings suggest that plant-produced anti-RSV mAbs are able to neutralize RSV <i>in vitro</i>.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10956629/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140177311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31Epub Date: 2024-03-22DOI: 10.1080/21645515.2024.2330768
Dung T Huynh, Emanuele Nolfi, Lobna Medfai, Peter van Ulsen, Wouter S P Jong, Alice J A M Sijts, Joen Luirink
Chlamydia trachomatis is an obligate intracellular pathogen responsible for the most prevalent bacterial sexually transmitted disease globally. The high prevalence of chlamydial infections underscores the urgent need for licensed and effective vaccines to prevent transmission in populations. Bacterial outer membrane vesicles (OMVs) have emerged as promising mucosal vaccine carriers due to their inherent adjuvant properties and the ability to display heterologous antigens. In this proof-of-concept study, we evaluated the immunogenicity of Salmonella OMVs decorated with C. trachomatis MOMP-derived CTH522 or HtrA antigens in mice. Following a prime-boost intranasal vaccination approach, two OMV-based C. trachomatis vaccines elicited significant humoral responses specific to the antigens in both systemic and vaginal compartments. Furthermore, we demonstrated strong antigen-specific IFN-γ and IL17a responses in splenocytes and cervical lymph node cells of vaccinated mice, indicating CD4+ Th1 and Th17 biased immune responses. Notably, the OMV-CTH522 vaccine also induced the production of spleen-derived CD8+ T cells expressing IFN-γ. In conclusion, these results highlight the potential of OMV-based C. trachomatis vaccines for successful use in future challenge studies and demonstrate the suitability of our modular OMV platform for intranasal vaccine applications.
{"title":"Intranasal delivery of <i>Salmonella</i> OMVs decorated with <i>Chlamydia trachomatis</i> antigens induces specific local and systemic immune responses.","authors":"Dung T Huynh, Emanuele Nolfi, Lobna Medfai, Peter van Ulsen, Wouter S P Jong, Alice J A M Sijts, Joen Luirink","doi":"10.1080/21645515.2024.2330768","DOIUrl":"10.1080/21645515.2024.2330768","url":null,"abstract":"<p><p><i>Chlamydia trachomatis</i> is an obligate intracellular pathogen responsible for the most prevalent bacterial sexually transmitted disease globally. The high prevalence of chlamydial infections underscores the urgent need for licensed and effective vaccines to prevent transmission in populations. Bacterial outer membrane vesicles (OMVs) have emerged as promising mucosal vaccine carriers due to their inherent adjuvant properties and the ability to display heterologous antigens. In this proof-of-concept study, we evaluated the immunogenicity of <i>Salmonella</i> OMVs decorated with <i>C. trachomatis</i> MOMP-derived CTH522 or HtrA antigens in mice. Following a prime-boost intranasal vaccination approach, two OMV-based <i>C. trachomatis</i> vaccines elicited significant humoral responses specific to the antigens in both systemic and vaginal compartments. Furthermore, we demonstrated strong antigen-specific IFN-γ and IL17a responses in splenocytes and cervical lymph node cells of vaccinated mice, indicating CD4<sup>+</sup> Th1 and Th17 biased immune responses. Notably, the OMV-CTH522 vaccine also induced the production of spleen-derived CD8<sup>+</sup> T cells expressing IFN-γ. In conclusion, these results highlight the potential of OMV-based <i>C. trachomatis</i> vaccines for successful use in future challenge studies and demonstrate the suitability of our modular OMV platform for intranasal vaccine applications.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962599/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31Epub Date: 2024-03-21DOI: 10.1080/21645515.2024.2304974
Prasad S Kulkarni, Chandrasekaran Padmapriyadarsini, Johan Vekemans, Ashish Bavdekar, Madhu Gupta, Praveen Kulkarni, B S Garg, Nithya J Gogtay, Muralidhar Tambe, Sanjay Lalwani, Kiranjit Singh, Renuka Munshi, Sushant Meshram, T S Selvavinayagam, Krishna Pandey, Devi Madhavi Bhimarasetty, S R Ramakrishnan, Chetanraj Bhamare, Abhijeet Dharmadhikari, Chandrashekhar Budhawant, Cyrille J Bonhomme, Madhuri Thakar, Swarali N Kurle, Elizabeth J Kelly, Manish Gautam, Nivedita Gupta, Samiran Panda, Balram Bhargava, Cyrus S Poonawalla, Umesh Shaligram, Dhananjay Kapse, Bhagwat Gunale
AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41-0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44-1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated.
AZD1222(ChAdOx1 nCoV-19)是一种复制缺陷型腺病毒载体冠状病毒病-19(COVID-19)疫苗,由印度血清研究所有限公司(Serum Institute of India Pvt Ltd)根据牛津大学/阿斯利康公司(Oxford University/AstraZeneca)的技术转让生产,名为 SII-ChAdOx1 nCoV-19。SII-ChAdOx1 nCoV-19 与 AZD1222 的非劣效性先前已在一项观察盲、2/3 期免疫桥接研究中得到证实(试验登记:CTRI/2020/08/027170)。在首次接种后 6 个月(第 180 天)的免疫原性和安全性数据分析中,1,601 名参与者按 3:1 的比例随机接种了 SII-ChAdOx1 nCoV-19 或 AZD1222(免疫原性/反应原性队列 n = 401),并按 3:1 的比例随机接种了 SII-ChAdOx1 nCoV-19 或安慰剂(安全性队列 n = 1,200)。免疫原性通过抗严重急性呼吸系统综合征冠状病毒 2 尖峰(抗-S)结合免疫球蛋白 G 和中和抗体(nAb)滴度来测定。两组疫苗接种者的抗-S滴度均出现下降,但SII-ChAdOx1 nCoV-19接种者的下降幅度更大(几何平均滴度[GMT]比值[SII-ChAdOx1 nCoV-19与AZD1222的95%置信区间(CI)]:0.60 [0.41-0.60]] :0.60 [0.41-0.87]).不同疫苗组之间的 nAb 滴度下降幅度相似(GMT 比值[95% CI]:0.88 [0.44-1.73])。接种疫苗后未出现严重的 COVID-19 病例,而安慰剂组出现了一例。180天内未报告任何与因果关系相关的严重不良事件。没有特别值得关注的血栓栓塞或自身免疫不良事件报告。总之,这些数据表明,SII-ChAdOx1 nCoV-19 在接种后 6 个月内保持了较高的免疫原性。SII-ChAdOx1 nCoV-19 安全且耐受性良好。
{"title":"Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults.","authors":"Prasad S Kulkarni, Chandrasekaran Padmapriyadarsini, Johan Vekemans, Ashish Bavdekar, Madhu Gupta, Praveen Kulkarni, B S Garg, Nithya J Gogtay, Muralidhar Tambe, Sanjay Lalwani, Kiranjit Singh, Renuka Munshi, Sushant Meshram, T S Selvavinayagam, Krishna Pandey, Devi Madhavi Bhimarasetty, S R Ramakrishnan, Chetanraj Bhamare, Abhijeet Dharmadhikari, Chandrashekhar Budhawant, Cyrille J Bonhomme, Madhuri Thakar, Swarali N Kurle, Elizabeth J Kelly, Manish Gautam, Nivedita Gupta, Samiran Panda, Balram Bhargava, Cyrus S Poonawalla, Umesh Shaligram, Dhananjay Kapse, Bhagwat Gunale","doi":"10.1080/21645515.2024.2304974","DOIUrl":"10.1080/21645515.2024.2304974","url":null,"abstract":"<p><p>AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort <i>n</i> = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort <i>n</i> = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41-0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44-1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962622/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}