{"title":"A randomized, observer-blind, controlled phase III clinical trial assessing safety and immunological non-inferiority of Vi-diphtheria toxoid versus Vi-tetanus toxoid typhoid conjugate vaccine in healthy volunteers in eastern Nepal.","authors":"Shipra Chaudhary, Gauri Shankar Shah, Nisha Keshary Bhatta, Prakash Poudel, Basant Rai, Surendra Uranw, Prashant Mani Tripathi, Basudha Khanal, Anup Ghimire, Nikita Rai, Birendra Prasad Gupta, Sridhar Vemula, T Anh Wartel, Sushant Sahastrabuddhe, Tarun Saluja","doi":"10.1080/21645515.2023.2203634","DOIUrl":"10.1080/21645515.2023.2203634","url":null,"abstract":"<p><p>Typhoid remains one of the major serious health concerns for children in developing countries. With extremely drug-resistant cases emerging, preventative measures like sanitation and vaccination, including typhoid conjugate vaccines (TCV) remain the mainstay in its prevention and control. Different types of TCVs are being developed to meet the global demand. This report outlines the results from a study done to assess the immunogenicity and safety of Vi-Diphtheria toxoid (Vi-DT) TCV in Nepal. The study was a randomized, active-controlled, immunological non-inferiority and safety study. Eligible participants from Sunsari and Morang districts of eastern Nepal were randomized into 4 study groups (A-D) within 3 age strata (6 months to <2 years, 2 to <18 years, and 18 to 45 years). Groups A to C received a single dose (25 μg) of Vi-DT test vaccine from any of the 3 lots, while group D received the comparator, Typbar-TCV®, Vi-tetanus toxoid (Vi-TT) vaccine (25 μg) in 1:1:1:1 ratio and evaluated at 4 weeks postvaccination with 6 months follow-up. Amongst 400 randomized participants, anti-Vi-IgG seroconversion rates for all age strata in Vi-DT pooled groups (A+B+C) were 100.00% (97.5% CI 98.34-100.00) vs 98.99% (97.5% CI 93.99-99.85) in Vi-TT group (D) at 4 weeks. Comparable safety events were reported between the groups. Three serious adverse events (1 in Vi-DT; 2 in Vi-TT group) were reported during the 6 months follow-up, none being related to the investigational product. Thus, Vi-DT vaccine is safe, immunogenic, and immunologically non-inferior to Vi-TT when analyzed at 4 weeks postvaccination.</p>","PeriodicalId":13058,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"19 1","pages":"2203634"},"PeriodicalIF":4.8,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10142305/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9756660","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}
Linda Kalunga, Ece Bulut, Ziqian Chen, Yihong Li, Renata Ivanek
{"title":"Increasing vaccine uptake among employees within the non-health related critical infrastructure sectors: A review.","authors":"Linda Kalunga, Ece Bulut, Ziqian Chen, Yihong Li, Renata Ivanek","doi":"10.1080/21645515.2022.2135852","DOIUrl":"10.1080/21645515.2022.2135852","url":null,"abstract":"<p><p>This review aimed to identify barriers to employee vaccination, motivators for vaccination, and vaccine uptake strategies within the critical infrastructure sectors. We focused on non-healthcare-related sectors, including food and agriculture, manufacturing, and education where employee vaccination is rarely mandated. We conducted a search for literature published from 2012 to 2022 from MEDLINE-PubMed, PsycINFO, and Web of Science Core Collection, which resulted in 22 studies that met the inclusion criteria. We found that 1) barriers to vaccination differ by infectious disease and population; 2) common motivators for vaccination were about protecting self, family, and community; and 3) common uptake strategies for influenza (which accounted for 83% of uptake strategies in reviewed studies) addressed convenience and confidence barriers such as vaccination cost and education. Our review highlights the need for employers, policymakers, and researchers to identify infectious disease and population-specific barriers to vaccination and implement strategies aimed at addressing the identified barriers.</p>","PeriodicalId":13058,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"19 1","pages":"2135852"},"PeriodicalIF":4.8,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e1/c9/KHVI_19_2135852.PMC9980543.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10825648","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}
Benjamin Z Kahn, Paul L Reiter, Katherine I Kritikos, Melissa B Gilkey, Tara L Queen, Noel T Brewer
{"title":"Framing of national HPV vaccine recommendations and willingness to recommend at ages 9-10.","authors":"Benjamin Z Kahn, Paul L Reiter, Katherine I Kritikos, Melissa B Gilkey, Tara L Queen, Noel T Brewer","doi":"10.1080/21645515.2023.2172276","DOIUrl":"10.1080/21645515.2023.2172276","url":null,"abstract":"<p><p>Proactive HPV vaccination at age 9 better prevents infection and improves vaccine series completion. Because national organizations recommend starting the vaccine at different ages, we sought to understand the impact of these recommendation frames. In 2022, we surveyed 2,527 US clinical staff (45% physicians) who provide HPV vaccine for children. We randomized respondents to one of three frames based on HPV vaccine recommendations of national organizations or a no-recommendation control, and assessed willingness to recommend HPV vaccine for children ages 9-10. Respondents also reported perceived benefits of HPV vaccination at ages 9 or 12. Recommending HPV vaccination \"at ages 11-12\" led to lower willingness to vaccinate at ages 9-10 than control (37% vs. 54%, <i>p</i> < .05). Recommending vaccination \"at ages 9-12\" led to similar willingness as control. However, \"starting at age 9\" led to higher willingness than control (63% vs. 54%, <i>p</i> < .05). Results were similar across respondents' training, specialty, or years in practice, or their clinic's rurality or healthcare system membership. More common benefits of recommending at age 9 than 12 were avoiding the topic of sex (24% vs. 10%, OR = 2.78, 95%CI: 2.23, 3.48) and completing the vaccine series before age 13 (56% vs. 47%, OR = 1.44, 95%CI: 1.23, 1.68). Less common benefits for age 9 were having parents ready to talk about HPV vaccine and agreeing to vaccination (both <i>p</i> < .05). An effective way to encourage proactive HPV vaccination is to say that it starts at age 9. Aligning national recommendations to start at age 9 can promote timely vaccination.</p>","PeriodicalId":13058,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"19 1","pages":"2172276"},"PeriodicalIF":4.8,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6b/d2/KHVI_19_2172276.PMC10012934.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9696276","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}
{"title":"Reply to the letter to the editor titled \"Guillain-Barre / Miller-Fisher overlap syndrome or acute, motor and sensory, axonal neuropathy with cranial nerve involvement?\"","authors":"Hao Liang, Wei Zhong, Jia Liu, Hong Chen","doi":"10.1080/21645515.2023.2206358","DOIUrl":"10.1080/21645515.2023.2206358","url":null,"abstract":"","PeriodicalId":13058,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"19 1","pages":"2206358"},"PeriodicalIF":4.8,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/77/91/KHVI_19_2206358.PMC10142310.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9399621","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}
Tomasz Sobierajski, Ilona Małecka, Ewa Augustynowicz
{"title":"Feminized vaccine? Parents' attitudes toward HPV vaccination of adolescents in Poland: A representative study.","authors":"Tomasz Sobierajski, Ilona Małecka, Ewa Augustynowicz","doi":"10.1080/21645515.2023.2186105","DOIUrl":"10.1080/21645515.2023.2186105","url":null,"abstract":"<p><p>In 2023, the process of gradually introducing universal, free HPV vaccination into the vaccination program for children in Poland began. For this reason, the attitudes of parents of adolescents toward these vaccinations were examined in this study. The survey was conducted among 360 parents of children (girls and boys) aged 9-15. To achieve the best possible representativeness of the sample, parents were selected for the survey using a random-quota method. The survey was carried out using the CATI. The surveyed parents declared a high level of knowledge about HPV and awareness of HPV vaccination (74.2% of parents had heard of HPV, and 61.4% had heard of the HPV vaccine). The study showed a statistically significant relationship between parents' education and knowledge of HPV infection - the higher the parent's (mother or father) education, the higher the declared knowledge. Education was also a statistically significant factor influencing the declaration of vaccinating a child against HPV. In addition to parental education, the gender of the child was also a significant factor influencing willingness to vaccinate against HPV. Parents of boys were significantly more likely - than parents of girls - to declare that they would not vaccinate their sons against HPV. A significant factor influencing declarations to vaccinate against HPV was the child's vaccination against COVID-19. The study results indicate a strong correlation between parental education and parental knowledge and attitudes about HPV and the HPV vaccine.</p>","PeriodicalId":13058,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"19 1","pages":"2186105"},"PeriodicalIF":4.8,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/78/58/KHVI_19_2186105.PMC10064925.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9354495","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}
Rakesh Awasthi, Harald J Maier, Jie Zhang, Stephen Lim
{"title":"Kymriah® (tisagenlecleucel) - An overview of the clinical development journey of the first approved CAR-T therapy.","authors":"Rakesh Awasthi, Harald J Maier, Jie Zhang, Stephen Lim","doi":"10.1080/21645515.2023.2210046","DOIUrl":"10.1080/21645515.2023.2210046","url":null,"abstract":"<p><p>The emergence of cell and gene therapies has dramatically changed the treatment paradigm in oncology and other therapeutic areas. Kymriah® (tisagenlecleucel), a CD19-directed genetically modified autologous T-cell immunotherapy, is currently approved in major markets for the treatment of relapsed/refractory (r/r) pediatric and young adult acute lymphoblastic leukemia, r/r diffuse large B-cell lymphoma, and r/r follicular lymphoma. This article presents a high-level overview of the clinical development journey of tisagenlecleucel, including its efficacy outcomes and safety considerations.</p>","PeriodicalId":13058,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"19 1","pages":"2210046"},"PeriodicalIF":4.8,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4b/4f/KHVI_19_2210046.PMC10294746.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9706829","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}
Moe H Kyaw, Julia Spinardi, Ling Zhang, Helen May Lin Oh, Amit Srivastava
{"title":"Evidence synthesis and pooled analysis of vaccine effectiveness for COVID-19 mRNA vaccine BNT162b2 as a heterologous booster after inactivated SARS-CoV-2 virus vaccines.","authors":"Moe H Kyaw, Julia Spinardi, Ling Zhang, Helen May Lin Oh, Amit Srivastava","doi":"10.1080/21645515.2023.2165856","DOIUrl":"10.1080/21645515.2023.2165856","url":null,"abstract":"<p><p>Introduction of primary COVID-19 vaccination has helped reduce severe disease and death caused by SARS-CoV-2 infection. Understanding the protection conferred by heterologous booster regimens informs alternative vaccination strategies that enable programmatic resilience and can catalyze vaccine confidence and coverage. Inactivated SARS-CoV-2 vaccines are among the most widely used vaccines worldwide. This review synthesizes the available evidence identified as of May 26, 2022, on the safety, immunogenicity, and effectiveness of a heterologous BNT162b2 (Pfizer-BioNTech) mRNA vaccine booster dose after an inactivated SARS-CoV-2 vaccine primary series, to help protect against COVID-19. Evidence showed that the heterologous BNT16b2 mRNA vaccine booster enhances immunogenicity and improves vaccine effectiveness against COVID-19, and no new safety concerns were identified with heterologous inactivated primary series with mRNA booster combinations.</p>","PeriodicalId":13058,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"19 1","pages":"2165856"},"PeriodicalIF":4.8,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d7/49/KHVI_19_2165856.PMC9980688.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10286783","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}
Luigi Roberto Biasio, Patrizio Zanobini, Chiara Lorini, Pietro Monaci, Alice Fanfani, Veronica Gallinoro, Gabriele Cerini, Giuseppe Albora, Marco Del Riccio, Sergio Pecorelli, Guglielmo Bonaccorsi
{"title":"COVID-19 vaccine literacy: A scoping review.","authors":"Luigi Roberto Biasio, Patrizio Zanobini, Chiara Lorini, Pietro Monaci, Alice Fanfani, Veronica Gallinoro, Gabriele Cerini, Giuseppe Albora, Marco Del Riccio, Sergio Pecorelli, Guglielmo Bonaccorsi","doi":"10.1080/21645515.2023.2176083","DOIUrl":"10.1080/21645515.2023.2176083","url":null,"abstract":"<p><p>To address vaccine hesitancy, specific self-rated tools have been developed to assess vaccine literacy (VL) related to COVID-19, including additional variables, such as beliefs, behavior, and willingness to be vaccinated. To explore the recent literature a search was performed selecting articles published between January 2020 and October 2022: 26 papers were identified using these tools in the context of COVID-19. Descriptive analysis showed that the levels of VL observed in the studies were generally in agreement, with functional VL score often lower than the interactive-critical dimension, as if the latter was stimulated by the COVID-19-related infodemic. Factors associated with VL included vaccination status, age, educational level, and, possibly, gender. Effective communication based on VL when promoting vaccination is critical to sustaining immunization against COVID-19 and other communicable diseases. The VL scales developed to date have shown good consistency. However, further research is needed to improve these tools and develop new ones.</p>","PeriodicalId":13058,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"19 1","pages":"2176083"},"PeriodicalIF":4.8,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/20/a4/KHVI_19_2176083.PMC10026896.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9211437","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}
{"title":"Progression of hemolysis in a patient with hereditary spherocytosis after the second dose of COVID-19 mRNA vaccine.","authors":"Jun Nomura, Masafumi Seki, Syori Abe, Tadahiro Kobayashi, Yoko Okitsu, Noriko Fukuhara, Shinichiro Takahashi, Hideo Harigae, Junichi Kameoka","doi":"10.1080/21645515.2023.2165381","DOIUrl":"10.1080/21645515.2023.2165381","url":null,"abstract":"<p><p>Herein, we report the case of a 22-year-old woman with hereditary spherocytosis (HS) whose condition worsened after administration of the coronavirus disease 2019 (COVID-19), mRNA vaccine 'BNT162b2 Pfizer-BioNTech.' The woman had been diagnosed with HS in 2005, and her condition remained stable until February 2021. In March 2021, she received the first dose of the above vaccine and experienced pain at the injection site. After the second dose in April 2021, she developed fever and general malaise. Investigations revealed progression of hemolysis, which improved after a few days. To the best of our knowledge, this is the first report of progression of hemolysis in a patient with HS after administration of the mRNA vaccine COVID-19, BNT162b2 'Pfizer-BioNTech.'</p>","PeriodicalId":13058,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"19 1","pages":"2165381"},"PeriodicalIF":4.8,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a1/7d/KHVI_19_2165381.PMC10012938.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9920376","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}
{"title":"Immune checkpoint inhibitors as first-line therapy for non-small cell lung cancer: A systematic evaluation and meta-analysis.","authors":"Yu Lu, Xiaoyan Zhang, Jiyu Ning, Manyan Zhang","doi":"10.1080/21645515.2023.2169531","DOIUrl":"10.1080/21645515.2023.2169531","url":null,"abstract":"<p><p>Recently, immune checkpoint inhibitors (ICIs) present promising application prospects in treating non-small cell lung cancer (NSCLC). This study aimed to investigate optimal treatment strategy by comparing the first-line treatment strategies with ICIs in NSCLC. We retrieved relevant studies on first-line therapy of NSCLC with ICIs. Primary outcomes were overall survival (OS) and progression-free survival (PFS). Secondary outcomes were treatment-related serious adverse events (tr-SAEs) with grade 3 or higher and objective response rate (ORR). We also conducted a Bayesian network meta-analysis. We included 14 studies involving 7,823 patients and compared seven different interventions. In PD-L1 nonselective NSCLC, nivolumab+ipilimumab had good PFS and ORR, pembrolizumab significantly prolonged OS, and nivolumab had the fewest adverse events (AEs). For PD-L1-positive patients, nivolumab remarkably prolonged OS. For those with negative PD-L1, nivolumab+ipilimumab also showed an advantage. In addition, nivolumab+ipilimumab significantly prolonged the PFS in both PD-L1-negative and -positive patients. For patients with PD-L1 tumor proportion score (TPS) within 1-49%, atezolizumab+chemotherapy remarkably prolonged PFS and OS. For those with PD-L1 TPS ≥50%, pembrolizumab prolonged OS and atezolizumab+chemotherapy significantly prolonged PFS. Nivolumab combined with ipilimumab showed advantages in OS, PFS and ORR in most patients. Nivolumab+ipilimumab may be the optimal first-line therapy for NSCLC.</p>","PeriodicalId":13058,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"19 1","pages":"2169531"},"PeriodicalIF":4.8,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/22/00/KHVI_19_2169531.PMC10038046.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9929646","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}