Purpose: The human papillomavirus (HPV) vaccine is safe and effective for preventing HPV-related diseases. However, HPV vaccination rates in Japan are low because the "Ministry of Health, Labour and Welfare" had stopped recommending vaccination. We assessed healthcare workers' (HCWs) current recommendations regarding the HPV vaccine and how the provision of information about HPV vaccination affected their recommendations.
Materials and methods: A survey was conducted among nurses and physicians in Nara prefecture from March 2021 to July 2021. The questionnaire asked about their understanding, recommendations, and opinions regarding HPV vaccination. Before answering the last two questions (optional), the HCWs read evidence-based information quantifying the risks and benefits of HPV vaccination.
Results: A total of 441 HCWs completed the questionnaire. Only 19% of HCWs always recommended HPV vaccination for girls aged 12-16 years. The evidence-based information significantly improved the percentage of HCWs who would "always recommend" vaccination.
Conclusion: This study showed that the proportion of HCWs who recommend HPV vaccination to adolescent girls remains low in Japan. However, we found that evidence-based information describing the causal relationship between adverse events and vaccination, quantifying the risks and benefits, noting the importance of HCW communications with families, and reporting the recommendations of national societies, might increase HCWs' recommendations for HPV vaccination.
{"title":"A survey of healthcare workers' recommendations about human papillomavirus vaccination.","authors":"Hitomi Nishioka, Tomoko Onishi, Taito Kitano, Masahiro Takeyama, Natsuko Imakita, Kei Kasahara, Ryuji Kawaguchi, Jennifer Akiko Masaki, Keiji Nogami","doi":"10.7774/cevr.2022.11.2.149","DOIUrl":"https://doi.org/10.7774/cevr.2022.11.2.149","url":null,"abstract":"<p><strong>Purpose: </strong>The human papillomavirus (HPV) vaccine is safe and effective for preventing HPV-related diseases. However, HPV vaccination rates in Japan are low because the \"Ministry of Health, Labour and Welfare\" had stopped recommending vaccination. We assessed healthcare workers' (HCWs) current recommendations regarding the HPV vaccine and how the provision of information about HPV vaccination affected their recommendations.</p><p><strong>Materials and methods: </strong>A survey was conducted among nurses and physicians in Nara prefecture from March 2021 to July 2021. The questionnaire asked about their understanding, recommendations, and opinions regarding HPV vaccination. Before answering the last two questions (optional), the HCWs read evidence-based information quantifying the risks and benefits of HPV vaccination.</p><p><strong>Results: </strong>A total of 441 HCWs completed the questionnaire. Only 19% of HCWs always recommended HPV vaccination for girls aged 12-16 years. The evidence-based information significantly improved the percentage of HCWs who would \"always recommend\" vaccination.</p><p><strong>Conclusion: </strong>This study showed that the proportion of HCWs who recommend HPV vaccination to adolescent girls remains low in Japan. However, we found that evidence-based information describing the causal relationship between adverse events and vaccination, quantifying the risks and benefits, noting the importance of HCW communications with families, and reporting the recommendations of national societies, might increase HCWs' recommendations for HPV vaccination.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5b/1f/cevr-11-149.PMC9200650.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40480090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-05-01Epub Date: 2022-05-31DOI: 10.7774/cevr.2022.11.2.163
Suparna Mazumder, Valerie Swank, Nina Dvorina, Justin M Johnson, Vincent K Tuohy
Purpose: Epithelial ovarian carcinoma (EOC) is the most lethal of all human gynecologic malignancies. We previously reported that vaccination of female mice with the extracellular domain of anti-Müllerian hormone receptor II (AMHR2-ED) in complete Freund's adjuvant (CFA) generates AMHR2-ED specific immunoglobulin G (IgG) that provides prevention and therapy against murine EOCs. Although CFA is the "gold standard" adjuvant in animal studies, it is not approved for human use because it often induces painful granulomas and abscesses. Thus, the objective of this study is to identify an alternative adjuvant to CFA for use in our ovarian cancer vaccine clinical trials.
Materials and methods: Because it has been used successfully without serious adverse effects in numerous human clinical trials, we selected the IgG-inducing squalene-based adjuvant, AddaVax™, for evaluation of its ability to facilitate vaccine-induced prevention and treatment of EOC in mice. To this end, we immunized female C57BL/6 mice with recombinant mouse AMHR2-ED emulsified with either AddaVax or CFA as adjuvant and compared the results.
Results: We found that formulation of the AMHR2-ED vaccine with AddaVax adjuvant induced high serum titers of IgG and significant inhibition of EOC growth with significantly enhanced overall survival of mice using both prevention and therapeutic protocols. These results were compared favorably with results obtained using CFA as an adjuvant in the AMHR2-ED vaccine.
Conclusion: Our data indicate that the AMHR2-ED vaccine formulated with AddaVax may be used in human clinical trials and thereby serve as a novel and effective way to control human EOC.
{"title":"Formulation of an ovarian cancer vaccine with the squalene-based AddaVax adjuvant inhibits the growth of murine epithelial ovarian carcinomas.","authors":"Suparna Mazumder, Valerie Swank, Nina Dvorina, Justin M Johnson, Vincent K Tuohy","doi":"10.7774/cevr.2022.11.2.163","DOIUrl":"https://doi.org/10.7774/cevr.2022.11.2.163","url":null,"abstract":"<p><strong>Purpose: </strong>Epithelial ovarian carcinoma (EOC) is the most lethal of all human gynecologic malignancies. We previously reported that vaccination of female mice with the extracellular domain of anti-Müllerian hormone receptor II (AMHR2-ED) in complete Freund's adjuvant (CFA) generates AMHR2-ED specific immunoglobulin G (IgG) that provides prevention and therapy against murine EOCs. Although CFA is the \"gold standard\" adjuvant in animal studies, it is not approved for human use because it often induces painful granulomas and abscesses. Thus, the objective of this study is to identify an alternative adjuvant to CFA for use in our ovarian cancer vaccine clinical trials.</p><p><strong>Materials and methods: </strong>Because it has been used successfully without serious adverse effects in numerous human clinical trials, we selected the IgG-inducing squalene-based adjuvant, AddaVax™, for evaluation of its ability to facilitate vaccine-induced prevention and treatment of EOC in mice. To this end, we immunized female C57BL/6 mice with recombinant mouse AMHR2-ED emulsified with either AddaVax or CFA as adjuvant and compared the results.</p><p><strong>Results: </strong>We found that formulation of the AMHR2-ED vaccine with AddaVax adjuvant induced high serum titers of IgG and significant inhibition of EOC growth with significantly enhanced overall survival of mice using both prevention and therapeutic protocols. These results were compared favorably with results obtained using CFA as an adjuvant in the AMHR2-ED vaccine.</p><p><strong>Conclusion: </strong>Our data indicate that the AMHR2-ED vaccine formulated with AddaVax may be used in human clinical trials and thereby serve as a novel and effective way to control human EOC.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/be/ee/cevr-11-163.PMC9200654.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40480116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.7774/cevr.2022.11.1.53
A. Al-Mariri, Laila Al-Hallab, Rasha Alabras, Heba Kherbik, Marwa Khawajkiah
Purpose Brucella spp. is a zoonosis that causes undulant fever in humans and abortion in livestock worldwide. Lately, it was conveyed that vaccines developed by irradiation have induced a strong cellular and humoral immune response which have made these types of vaccines highly effective. Materials and Methods In this study, we aimed to use the gamma-irradiated B. ovis as a vaccine and to study the humoral immune response and cytokines production in order to evaluate it for protecting mice against B. abortus 544, B. melitensis 16M, and B. ovis. Results The humoral immune response in immunized mice with gamma-irradiated B. ovis showed a lasting for 8 weeks after immunization. Moreover, immunoglobulin G (IgG), IgG1, IgG2a, and IgG2b isotypes antibodies against B. ovis were observed after 4 and 8 weeks of the last immunization. It was noticed that the production of tumor necrosis factor-α, interferon-γ, and interleukin (IL)-10 continued after 4 and 8 weeks by splenocytes from immunized BALB/c mice, while no production of IL-4 or IL-5 was observed. Conclusion Our results indicate that the protection of BALB/c mice against B. melitensis 16M, B. abortus 544, and B. ovis was induced and the developed vaccine at our laboratory could stimulate similar protection to those induced by the traditional vaccine.
{"title":"Protection against virulent Brucella spp. by gamma-irradiated B. ovis in BALB/c mice model","authors":"A. Al-Mariri, Laila Al-Hallab, Rasha Alabras, Heba Kherbik, Marwa Khawajkiah","doi":"10.7774/cevr.2022.11.1.53","DOIUrl":"https://doi.org/10.7774/cevr.2022.11.1.53","url":null,"abstract":"Purpose Brucella spp. is a zoonosis that causes undulant fever in humans and abortion in livestock worldwide. Lately, it was conveyed that vaccines developed by irradiation have induced a strong cellular and humoral immune response which have made these types of vaccines highly effective. Materials and Methods In this study, we aimed to use the gamma-irradiated B. ovis as a vaccine and to study the humoral immune response and cytokines production in order to evaluate it for protecting mice against B. abortus 544, B. melitensis 16M, and B. ovis. Results The humoral immune response in immunized mice with gamma-irradiated B. ovis showed a lasting for 8 weeks after immunization. Moreover, immunoglobulin G (IgG), IgG1, IgG2a, and IgG2b isotypes antibodies against B. ovis were observed after 4 and 8 weeks of the last immunization. It was noticed that the production of tumor necrosis factor-α, interferon-γ, and interleukin (IL)-10 continued after 4 and 8 weeks by splenocytes from immunized BALB/c mice, while no production of IL-4 or IL-5 was observed. Conclusion Our results indicate that the protection of BALB/c mice against B. melitensis 16M, B. abortus 544, and B. ovis was induced and the developed vaccine at our laboratory could stimulate similar protection to those induced by the traditional vaccine.","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48490374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.7774/cevr.2022.11.1.12
Shaimaa Abulmagd, A. E. Khattab, H. Zedan
Purpose In the present study, whole diphtheria toxin (dt) and fragment B (dtb) genes from Corynebacterium diphtheriae Park William were cloned into Escherichia coli, the purified expressed proteins were evaluated for ultimately using as a candidate vaccine. Materials and Methods The dt and dtb genes were isolated from bacterial strain ATCC (American Type Culture Collection) no. 13812. Plasmid pET29a+ was extracted by DNA-spin TM plasmid purification kit where genes were inserted using BamHI and HindIII-HF. Cloned pET29a+dt and pET29a+dtb plasmids were transformed into E. coli BL21(DE3)PlysS as expression host. The identity of the sequences was validated by blasting the sequence (BLASTn) against all the reported nucleotide sequences in the NCBI (National Center for Biotechnology Information) GenBank. Production of proteins in high yield by different types and parameters of fermentation to determine optimal conditions. Lastly, the purified concentrated rdtx and rdtb were injected to BALB/c mice and antibody titers were detected. Results The genetic transformation of E. coli DH5α and E. coli BL21 with the pET-29a(+) carrying the dt and dtb genes was confirmed by colony polymerase chain reaction assay and were positive to grow on Luria-Bertani/kanamycin medium. The open reading frame of dt and dtb sequences consisted of 1,600 bp and 1,000 bp, were found to be 100% identical to dt and dtb sequence of C. diphtheriae (accession number KX702999.1 and KX702993.1) respectively. The optimal condition for high cell density is fed-batch fermentation production to express the rdtx and rdtb at 280 and 240 Lf/mL, dissolved oxygen was about 24% and 22% and the dry cell weight of bacteria was 2.41 g/L and 2.18 g/L, respectively. Conclusion This study concluded with success in preparing genetically modified two strains for the production of a diphtheria vaccine, and to reach ideal production conditions to achieve the highest productivity.
目的本研究将白喉棒状杆菌Park William的白喉毒素（dt）和B片段（dtb）基因克隆到大肠杆菌中，并对纯化的表达蛋白进行评价，最终用作候选疫苗。材料和方法从ATCC（American Type Culture Collection）13812菌株中分离出dt和dtb基因。质粒pET29a+通过DNA spin-TM质粒纯化试剂盒提取，其中使用BamHI和HindIII-HF插入基因。将克隆的pET29a+dt和pET29a+dtb质粒转化到大肠杆菌BL21（DE3）PlysS中作为表达宿主。通过对NCBI（国家生物技术信息中心）GenBank中所有报道的核苷酸序列爆破序列（BLASTn）来验证序列的同一性。通过不同类型和参数的发酵来确定高产蛋白质的最佳条件。最后，将纯化的浓缩rdtx和rdtb注射到BALB/c小鼠中，并检测抗体滴度。结果用携带dt和dtb基因的pET-29a（+）对大肠杆菌DH5α和大肠杆菌BL21进行了遗传转化，并在Luria Bertani/卡那霉素培养基上呈阳性生长。发现由1600bp和1000bp组成的dt和dtb序列的开放阅读框分别与白喉杆菌的dt和dtb序列（登录号KX702999.1和KX702993.1）100%相同。高细胞密度的最佳条件是补料分批发酵生产，以280和240Lf/mL表达rdtx和rdtb，溶解氧约为24%和22%，细菌干细胞重量分别为2.41g/L和2.18g/L。结论本研究成功地制备了两株用于生产白喉疫苗的转基因菌株，并达到了理想的生产条件，达到了最高的生产效率。
{"title":"Expression of full and fragment-B of diphtheria toxin genes in Escherichia coli for generating of recombinant diphtheria vaccines","authors":"Shaimaa Abulmagd, A. E. Khattab, H. Zedan","doi":"10.7774/cevr.2022.11.1.12","DOIUrl":"https://doi.org/10.7774/cevr.2022.11.1.12","url":null,"abstract":"Purpose In the present study, whole diphtheria toxin (dt) and fragment B (dtb) genes from Corynebacterium diphtheriae Park William were cloned into Escherichia coli, the purified expressed proteins were evaluated for ultimately using as a candidate vaccine. Materials and Methods The dt and dtb genes were isolated from bacterial strain ATCC (American Type Culture Collection) no. 13812. Plasmid pET29a+ was extracted by DNA-spin TM plasmid purification kit where genes were inserted using BamHI and HindIII-HF. Cloned pET29a+dt and pET29a+dtb plasmids were transformed into E. coli BL21(DE3)PlysS as expression host. The identity of the sequences was validated by blasting the sequence (BLASTn) against all the reported nucleotide sequences in the NCBI (National Center for Biotechnology Information) GenBank. Production of proteins in high yield by different types and parameters of fermentation to determine optimal conditions. Lastly, the purified concentrated rdtx and rdtb were injected to BALB/c mice and antibody titers were detected. Results The genetic transformation of E. coli DH5α and E. coli BL21 with the pET-29a(+) carrying the dt and dtb genes was confirmed by colony polymerase chain reaction assay and were positive to grow on Luria-Bertani/kanamycin medium. The open reading frame of dt and dtb sequences consisted of 1,600 bp and 1,000 bp, were found to be 100% identical to dt and dtb sequence of C. diphtheriae (accession number KX702999.1 and KX702993.1) respectively. The optimal condition for high cell density is fed-batch fermentation production to express the rdtx and rdtb at 280 and 240 Lf/mL, dissolved oxygen was about 24% and 22% and the dry cell weight of bacteria was 2.41 g/L and 2.18 g/L, respectively. Conclusion This study concluded with success in preparing genetically modified two strains for the production of a diphtheria vaccine, and to reach ideal production conditions to achieve the highest productivity.","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47447762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01Epub Date: 2022-01-31DOI: 10.7774/cevr.2022.11.1.96
Alexander Krüttgen, Gerhard Haase, Helga Haefner, Matthias Imöhl, Michael Kleines
Purpose: Studies on the immune responses to severe acute respiratory syndrome coronavirus 2 vaccines are necessary to evaluate the ongoing vaccination programs by correlating serological response data and clinical effectiveness data. We performed a longitudinal immunological profiling of health care workers vaccinated with mRNA-1273 (Moderna, Cambridge, MA, USA). Half of these vaccinees had experienced a mild coronavirus disease 2019 (COVID-19) infection in the spring of 2020 ("COVID-recovered" cohort), whereas the other half of the vaccinees had no previous COVID-19 infection ("COVID-naive" cohort).
Materials and methods: Serum was drawn at multiple time points and subjected to assays measuring anti-Spike immunoglobulin G (IgG), avidity of anti-Spike IgG, avidity of anti-receptor binding domain (RBD) IgG, virus neutralizing activity, and interferon-γ release from stimulated lymphocytes.
Results: Between both cohorts and within each cohort, we found remarkable inter-individual differences regarding cellular and humoral immune responses to the Moderna mRNA-1273 vaccine.
Conclusion: First, our study indicates that the success of mRNA-1273 vaccinations should be verified by serological assays in order to identify "low-responders" to vaccination. Second, the kinetics of anti-S IgG and neutralizing activity correlate well with clinical effectiveness data, thus explaining incipient protection against infection 2 weeks after the first dose of mRNA-1273 in COVID-naive vaccinees. Third, our IgG-avidity data indicate that this incipient protection is mediated by low-avidity anti-RBD IgG and low-avidity anti-S IgG.
{"title":"Large inter-individual variability of cellular and humoral immunological responses to mRNA-1273 (Moderna) vaccination against SARS-CoV-2 in health care workers.","authors":"Alexander Krüttgen, Gerhard Haase, Helga Haefner, Matthias Imöhl, Michael Kleines","doi":"10.7774/cevr.2022.11.1.96","DOIUrl":"10.7774/cevr.2022.11.1.96","url":null,"abstract":"<p><strong>Purpose: </strong>Studies on the immune responses to severe acute respiratory syndrome coronavirus 2 vaccines are necessary to evaluate the ongoing vaccination programs by correlating serological response data and clinical effectiveness data. We performed a longitudinal immunological profiling of health care workers vaccinated with mRNA-1273 (Moderna, Cambridge, MA, USA). Half of these vaccinees had experienced a mild coronavirus disease 2019 (COVID-19) infection in the spring of 2020 (\"COVID-recovered\" cohort), whereas the other half of the vaccinees had no previous COVID-19 infection (\"COVID-naive\" cohort).</p><p><strong>Materials and methods: </strong>Serum was drawn at multiple time points and subjected to assays measuring anti-Spike immunoglobulin G (IgG), avidity of anti-Spike IgG, avidity of anti-receptor binding domain (RBD) IgG, virus neutralizing activity, and interferon-γ release from stimulated lymphocytes.</p><p><strong>Results: </strong>Between both cohorts and within each cohort, we found remarkable inter-individual differences regarding cellular and humoral immune responses to the Moderna mRNA-1273 vaccine.</p><p><strong>Conclusion: </strong>First, our study indicates that the success of mRNA-1273 vaccinations should be verified by serological assays in order to identify \"low-responders\" to vaccination. Second, the kinetics of anti-S IgG and neutralizing activity correlate well with clinical effectiveness data, thus explaining incipient protection against infection 2 weeks after the first dose of mRNA-1273 in COVID-naive vaccinees. Third, our IgG-avidity data indicate that this incipient protection is mediated by low-avidity anti-RBD IgG and low-avidity anti-S IgG.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8844675/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44525660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.7774/cevr.2022.11.1.121
Hanna Klingel, Maike Lauen, A. Krüttgen, M. Imöhl, M. Kleines
Knowledge about mRNA-1273 elicited T-cell response is limited. We investigated adverse reactions and interferon gamma release by specific T-cells among mRNA-1273 vaccinated health care workers. Seven to 13 weeks after complete vaccination low levels of specific T-cells were detected not correlating with antibody response. Severity of symptoms after first and number of symptoms after second immunization were associated with T-cell response. Assessment of T-cell response in addition to antibody response is crucial because even few specific T-cells could add to protection against infection. Investigation of mRNA-1273 induced inflammatory processes might help improve reactogenicity and immunogenicity.
{"title":"Severity of adverse reactions is associated with T-cell response in mRNA-1273 vaccinated health care workers","authors":"Hanna Klingel, Maike Lauen, A. Krüttgen, M. Imöhl, M. Kleines","doi":"10.7774/cevr.2022.11.1.121","DOIUrl":"https://doi.org/10.7774/cevr.2022.11.1.121","url":null,"abstract":"Knowledge about mRNA-1273 elicited T-cell response is limited. We investigated adverse reactions and interferon gamma release by specific T-cells among mRNA-1273 vaccinated health care workers. Seven to 13 weeks after complete vaccination low levels of specific T-cells were detected not correlating with antibody response. Severity of symptoms after first and number of symptoms after second immunization were associated with T-cell response. Assessment of T-cell response in addition to antibody response is crucial because even few specific T-cells could add to protection against infection. Investigation of mRNA-1273 induced inflammatory processes might help improve reactogenicity and immunogenicity.","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44645273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.7774/cevr.2022.11.1.104
A. Sanyaolu, A. Marinkovic, S. Prakash, P. Desai, N. Haider, A. Abbasi, Nasima Mehraban, Isha Jain, Amarachi Ekeh, Omar Shazley, C. Okorie, V. Orish
Purpose In the United States, Pfizer-BioNTech, Moderna, and Janssen’s coronavirus disease 2019 (COVID-19) vaccines have been granted Emergency Use Authorization (EUA) with the Pfizer-BioNTech vaccine presently approved by the US Food and Drug Administration. The purpose of this study is to analyze passive surveillance data on COVID-19 vaccine adverse reaction in the United States. Materials and Methods We analyzed passive surveillance data on COVID-19 vaccine adverse reactions which were retrieved from the Vaccine Adverse Event Reporting System database. Retrieved records on demographic information as well as the top 10 common vaccine adverse events were extracted and assessed from 200 of the most recently reported cases for the study analysis. Results Local and systemic adverse reactions were reported in the study. A significant difference (p<0.05) was recorded for the top 10 systemic reactions by age category (0.041) and by gender (0.002). Analysis of the top five systemic reactions, stratified by vaccine type yielded a significant difference (p<0.05) for chills (p=0.044), and when stratified by age group and type of vaccination received, it yielded a significant difference (p<0.05) for fatigue (p=0.023). Overall, Pfizer had 182 persons (91.0%) reporting adverse events, Moderna with 13 (6.5%), and Janssen with 5 (2.5%). Conclusion Mild side effects were reported following vaccination with the EUA COVID-19 vaccines in the United States. Thus, continuous monitoring and reporting of all adverse events are recommended to ensure the safety of vaccination.
{"title":"Reactogenicity to COVID-19 vaccination in the United States of America","authors":"A. Sanyaolu, A. Marinkovic, S. Prakash, P. Desai, N. Haider, A. Abbasi, Nasima Mehraban, Isha Jain, Amarachi Ekeh, Omar Shazley, C. Okorie, V. Orish","doi":"10.7774/cevr.2022.11.1.104","DOIUrl":"https://doi.org/10.7774/cevr.2022.11.1.104","url":null,"abstract":"Purpose In the United States, Pfizer-BioNTech, Moderna, and Janssen’s coronavirus disease 2019 (COVID-19) vaccines have been granted Emergency Use Authorization (EUA) with the Pfizer-BioNTech vaccine presently approved by the US Food and Drug Administration. The purpose of this study is to analyze passive surveillance data on COVID-19 vaccine adverse reaction in the United States. Materials and Methods We analyzed passive surveillance data on COVID-19 vaccine adverse reactions which were retrieved from the Vaccine Adverse Event Reporting System database. Retrieved records on demographic information as well as the top 10 common vaccine adverse events were extracted and assessed from 200 of the most recently reported cases for the study analysis. Results Local and systemic adverse reactions were reported in the study. A significant difference (p<0.05) was recorded for the top 10 systemic reactions by age category (0.041) and by gender (0.002). Analysis of the top five systemic reactions, stratified by vaccine type yielded a significant difference (p<0.05) for chills (p=0.044), and when stratified by age group and type of vaccination received, it yielded a significant difference (p<0.05) for fatigue (p=0.023). Overall, Pfizer had 182 persons (91.0%) reporting adverse events, Moderna with 13 (6.5%), and Janssen with 5 (2.5%). Conclusion Mild side effects were reported following vaccination with the EUA COVID-19 vaccines in the United States. Thus, continuous monitoring and reporting of all adverse events are recommended to ensure the safety of vaccination.","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43802973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.7774/cevr.2022.11.1.129
G. Gallo, L. Mastorino, L. Tonella, S. Ribero, P. Quaglino
The coronavirus disease 2019 (COVID-19) vaccines are authorized for use in numerous countries worldwide. Several cutaneous findings are reported after severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) vaccination. Here, we report the case of a patient with a rapid onset of alopecia areata immediately after receiving the second dose of the COVID-19 vaccine. Alopecia areata is a common autoimmune disease leading to non-scarring hair loss. Among the many cutaneous adverse effects reported after the anti-SARS-COV2 vaccination, no episodes of alopecia areata have been described to date. In this paper, we report the first case of alopecia areata after COVID-19 vaccination described in the literature with a revision of cases of alopecia areata reported after other types of vaccination. Although the significance of these skin reactions is not yet known, further studies will certainly clarify whether the development of alopecia areata or other forms of immune-mediated reactions could represent a positive prognostic factor regarding immune protection from SARS-CoV-2.
{"title":"Alopecia areata after COVID-19 vaccination","authors":"G. Gallo, L. Mastorino, L. Tonella, S. Ribero, P. Quaglino","doi":"10.7774/cevr.2022.11.1.129","DOIUrl":"https://doi.org/10.7774/cevr.2022.11.1.129","url":null,"abstract":"The coronavirus disease 2019 (COVID-19) vaccines are authorized for use in numerous countries worldwide. Several cutaneous findings are reported after severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) vaccination. Here, we report the case of a patient with a rapid onset of alopecia areata immediately after receiving the second dose of the COVID-19 vaccine. Alopecia areata is a common autoimmune disease leading to non-scarring hair loss. Among the many cutaneous adverse effects reported after the anti-SARS-COV2 vaccination, no episodes of alopecia areata have been described to date. In this paper, we report the first case of alopecia areata after COVID-19 vaccination described in the literature with a revision of cases of alopecia areata reported after other types of vaccination. Although the significance of these skin reactions is not yet known, further studies will certainly clarify whether the development of alopecia areata or other forms of immune-mediated reactions could represent a positive prognostic factor regarding immune protection from SARS-CoV-2.","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42708568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.7774/cevr.2022.11.1.89
J. Wibowo, R. Heriyanto, F. Wijovi, D. A. Halim, C. Claudia, E. Marcella, B. Susanto, Michele Indrawan, Nadia Khoirunnisa Heryadi, Michelle Imanuelly, Jonathan Juniard Anurantha, T. Hariyanto, C.P.G.P.P. Marcellin, Terry Devita Sinaga, Saraswati Anindita Rizki, N. Sieto, J. Siregar, N. Lugito, A. Kurniawan
Purpose As coronavirus disease 2019 (COVID-19) continues to spread rapidly causing approximately 186 million confirmed cases around the world, the urgency to reach herd immunity through vaccination is increasing. However, vaccine safety is a top priority to limit the occurrence of adverse events. Henceforth, this study aims to recognize and perceive COVID-19 vaccine safety in Indonesia during the pandemic. Materials and Methods This is a cross-sectional study and was conducted in Indonesia during the COVID-19 pandemic using an online survey of demographic information and a qualitative questionnaire. Responses were recorded and the association between demographic characteristics from survey questions was tested using chi-square with a risk estimate and 95% confidence interval. Results A total of 311 participants from 33 out of 34 provinces in Indonesia participated in this study. Recorded responses showed multiple side effects of the COVID-19 vaccine both short- and long-term experienced by the participants. Significant associations were found between demographic factors and COVID-19 vaccine side effects such as female gender with short-term puncture site (odds ratio [OR], 0.463; 95% confidence interval [CI], 0.263–0.816) and short-term other reactions (OR, 0.463; 95% CI, 0.263–0.816), domicile outside Java island with long-term puncture site (OR, 4.219; 95% CI, 1.401–12.701) and immune reactions (OR, 3.375; 95% CI, 1.356–8.398), also between married marital status and long-term vagal reaction (OR, 4.655; 95% CI, 1.321–16.409). Conclusion Gender, domicile and marital status factors were associated with COVID-19 vaccine side effects in Indonesian people.
{"title":"Factors associated with side effects of COVID-19 vaccine in Indonesia","authors":"J. Wibowo, R. Heriyanto, F. Wijovi, D. A. Halim, C. Claudia, E. Marcella, B. Susanto, Michele Indrawan, Nadia Khoirunnisa Heryadi, Michelle Imanuelly, Jonathan Juniard Anurantha, T. Hariyanto, C.P.G.P.P. Marcellin, Terry Devita Sinaga, Saraswati Anindita Rizki, N. Sieto, J. Siregar, N. Lugito, A. Kurniawan","doi":"10.7774/cevr.2022.11.1.89","DOIUrl":"https://doi.org/10.7774/cevr.2022.11.1.89","url":null,"abstract":"Purpose As coronavirus disease 2019 (COVID-19) continues to spread rapidly causing approximately 186 million confirmed cases around the world, the urgency to reach herd immunity through vaccination is increasing. However, vaccine safety is a top priority to limit the occurrence of adverse events. Henceforth, this study aims to recognize and perceive COVID-19 vaccine safety in Indonesia during the pandemic. Materials and Methods This is a cross-sectional study and was conducted in Indonesia during the COVID-19 pandemic using an online survey of demographic information and a qualitative questionnaire. Responses were recorded and the association between demographic characteristics from survey questions was tested using chi-square with a risk estimate and 95% confidence interval. Results A total of 311 participants from 33 out of 34 provinces in Indonesia participated in this study. Recorded responses showed multiple side effects of the COVID-19 vaccine both short- and long-term experienced by the participants. Significant associations were found between demographic factors and COVID-19 vaccine side effects such as female gender with short-term puncture site (odds ratio [OR], 0.463; 95% confidence interval [CI], 0.263–0.816) and short-term other reactions (OR, 0.463; 95% CI, 0.263–0.816), domicile outside Java island with long-term puncture site (OR, 4.219; 95% CI, 1.401–12.701) and immune reactions (OR, 3.375; 95% CI, 1.356–8.398), also between married marital status and long-term vagal reaction (OR, 4.655; 95% CI, 1.321–16.409). Conclusion Gender, domicile and marital status factors were associated with COVID-19 vaccine side effects in Indonesian people.","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46645747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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