Pub Date : 2024-08-20DOI: 10.1016/j.jvacx.2024.100549
Grant Murewanhema , Enos Moyo , Mathias Dzobo , Rachel S. Mandishora-Dube , Tafadzwa Dzinamarira
Human papillomaviruses (HPV) cause 99% of all cervical cancer cases globally, with the high-risk genotypes 16 and 18 causing at least 70% of these cases. An estimated 90% of the global cervical cancer burden occurs in low-to-middle-income countries (LMICs), particularly in sub-Saharan Africa (SSA). Primary prevention through the administration of efficacious HPV vaccines is key to the World Health Organization’s global strategy for accelerating the elimination of cervical cancer as a disease of public health concern. The rollout of HPV vaccination in SSA is faced with several challenges, such as the high cost of vaccine procurement, a lack of funding and political will from the central governments of countries, and inadequate infrastructure for vaccine cold chain storage and transport. Stigma, misinformation, lack of education and awareness, and vaccine hesitancy constitute the social factors that affect the successful rollout or implementation of vaccination programs in SSA. Based on the challenges SSA faces in rolling out HPV vaccination, we recommend using strategies that address both the demand-side and supply-side obstacles to HPV vaccination uptake. These include costs and availability, fighting vaccine hesitancy, and increasing vaccine confidence.
{"title":"Human papilloma virus vaccination in the resource-limited settings of sub-Saharan Africa: Challenges and recommendations","authors":"Grant Murewanhema , Enos Moyo , Mathias Dzobo , Rachel S. Mandishora-Dube , Tafadzwa Dzinamarira","doi":"10.1016/j.jvacx.2024.100549","DOIUrl":"10.1016/j.jvacx.2024.100549","url":null,"abstract":"<div><p>Human papillomaviruses (HPV) cause 99% of all cervical cancer cases globally, with the high-risk genotypes 16 and 18 causing at least 70% of these cases. An estimated 90% of the global cervical cancer burden occurs in low-to-middle-income countries (LMICs), particularly in sub-Saharan Africa (SSA). Primary prevention through the administration of efficacious HPV vaccines is key to the World Health Organization’s global strategy for accelerating the elimination of cervical cancer as a disease of public health concern. The rollout of HPV vaccination in SSA is faced with several challenges, such as the high cost of vaccine procurement, a lack of funding and political will from the central governments of countries, and inadequate infrastructure for vaccine cold chain storage and transport. Stigma, misinformation, lack of education and awareness, and vaccine hesitancy constitute the social factors that affect the successful rollout or implementation of vaccination programs in SSA. Based on the challenges SSA faces in rolling out HPV vaccination, we recommend using strategies that address both the demand-side and supply-side obstacles to HPV vaccination uptake. These include costs and availability, fighting vaccine hesitancy, and increasing vaccine confidence.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100549"},"PeriodicalIF":2.7,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001220/pdfft?md5=0c617d253b401e682b1150fd6a0b9b9e&pid=1-s2.0-S2590136224001220-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142047897","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 : 2024-08-16DOI: 10.1016/j.jvacx.2024.100548
Dorthe Maria Vittrup , Andreas Jensen , Michelle Malon , Anne Cathrine Zimakoff , Jesper Kiehn Sørensen , Brickley Littell , Eric A.F. Simões , Jannet Svensson , Lone Graff Stensballe
Background
Assessing the risk of measles outbreaks and identifying the susceptible parts of the population is essential to timely intervention. Infants between 6–12 months are increasingly susceptible to measles but evaluating the performance of high throughput enzyme immunoassays (ELISAs) in infants < 9 months of age is lacking.
Methods
A commercially available ELISA kit (Creative Diagnostics, DEIA359) for estimating measles seroprotection was evaluated in infants 5–7 months of age. In an immunogenicity substudy in the Danish MMR trial conducted between 2019–2021, infants (and mothers at baseline) were sampled before and one month after measles-mumps-rubella vaccination (MMR) or placebo as well as one month after routine MMR at 15 months. Measles IgG ELISA was compared to the gold standard but labor-intensive measles plaque reduction neutralization test (PRNT) by Pearson and Spearman correlations and by estimating sensitivity, specificity, and positive and negative predictive values (PPV and NPV).
Findings
Measles IgG levels compared to PRNT antibodies had a Pearson’s correlation coefficient between 0.10–0.24. Seroprotection rates measured by ELISA in young infants were 10–14% lower than measured by PRNT. The sensitivity of the ELISA to detect serological protection compared to PRNT in the infant population differed markedly across sampling time points and was 14%, 40%, and 92% at baseline, post-intervention, and post-routine MMR, whereas the specificity was 99%, 93%, and 43%, respectively. The PPV and NPV were 68% and 87% in infants at baseline.
Interpretation
The correlation between measles IgG and PRNT antibodies was low. Seroprotection was underestimated using ELISA. High-accuracy tests are needed to avoid misclassifications and practices that lead to primary or secondary vaccine failure or retention of vaccination in outbreak settings. Baseline PPV and NPV suggested some applicability of ELISA in predicting serological protection in this age group. However, PRNT may be the only accurate estimator of serological protection in young infants.
{"title":"Comparison of measles plaque reduction neutralization test (PRNT) and measles virus-specific IgG ELISA for assessment of immunogenicity of measles-mumps-rubella vaccination at 5–7 months of age and maternal measles antibodies","authors":"Dorthe Maria Vittrup , Andreas Jensen , Michelle Malon , Anne Cathrine Zimakoff , Jesper Kiehn Sørensen , Brickley Littell , Eric A.F. Simões , Jannet Svensson , Lone Graff Stensballe","doi":"10.1016/j.jvacx.2024.100548","DOIUrl":"10.1016/j.jvacx.2024.100548","url":null,"abstract":"<div><h3>Background</h3><p>Assessing the risk of measles outbreaks and identifying the susceptible parts of the population is essential to timely intervention. Infants between 6–12 months are increasingly susceptible to measles but evaluating the performance of high throughput enzyme immunoassays (ELISAs) in infants < 9 months of age is lacking.</p></div><div><h3>Methods</h3><p>A commercially available ELISA kit (Creative Diagnostics, DEIA359) for estimating measles seroprotection was evaluated in infants 5–7 months of age. In an immunogenicity substudy in the Danish MMR trial conducted between 2019–2021, infants (and mothers at baseline) were sampled before and one month after measles-mumps-rubella vaccination (MMR) or placebo as well as one month after routine MMR at 15 months. Measles IgG ELISA was compared to the gold standard but labor-intensive measles plaque reduction neutralization test (PRNT) by Pearson and Spearman correlations and by estimating sensitivity, specificity, and positive and negative predictive values (PPV and NPV).</p></div><div><h3>Findings</h3><p>Measles IgG levels compared to PRNT antibodies had a Pearson’s correlation coefficient between 0.10–0.24. Seroprotection rates measured by ELISA in young infants were 10–14% lower than measured by PRNT. The sensitivity of the ELISA to detect serological protection compared to PRNT in the infant population differed markedly across sampling time points and was 14%, 40%, and 92% at baseline, post-intervention, and post-routine MMR, whereas the specificity was 99%, 93%, and 43%, respectively. The PPV and NPV were 68% and 87% in infants at baseline.</p></div><div><h3>Interpretation</h3><p>The correlation between measles IgG and PRNT antibodies was low. Seroprotection was underestimated using ELISA. High-accuracy tests are needed to avoid misclassifications and practices that lead to primary or secondary vaccine failure or retention of vaccination in outbreak settings. Baseline PPV and NPV suggested some applicability of ELISA in predicting serological protection in this age group. However, PRNT may be the only accurate estimator of serological protection in young infants.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100548"},"PeriodicalIF":2.7,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001219/pdfft?md5=86c68ece9fe4677f8fc2c33d51c94a1e&pid=1-s2.0-S2590136224001219-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142012235","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}
Stringent public health and social measures against COVID-19 infection were implemented to avoid an overwhelming hospital caseload and excessive number of deaths, especially among elderly people. We analyzed population-level immunity and predicted mortality, calculated as the potential number of deaths on a given calendar date in Japan, to develop a science-based exit strategy from stringent control measures.
Methods
Immune proportions were inferred by age group using vaccination coverage data and the estimated number of naturally infected individuals. Immunity against symptomatic illness and death were estimated separately, allowing for inference of the immune fraction that was protected against either COVID-19-related symptomatic infection or death. By multiplying the infection fatality risk by age group for the immune fraction, the potential number of deaths was obtained.
Results
Accounting for a second and third dose of messenger RNA vaccine in the present-day population, approximately 155,000 potential deaths would be expected among people aged ≥ 60 years if all individuals were infected at the very end of 2022. A fourth dose (i.e., second booster) with a coverage identical to that of the third dose could reduce mortality by 60%. In all examined settings, the largest number of deaths occurred among people aged 80 years and older.
Conclusions
Our estimates can help policymakers understand the mortality impact of the COVID-19 epidemic in a quantitative manner and the critical importance of timely immunization so as to assist in decision making.
{"title":"Science-based exit from stringent countermeasures against COVID-19: Mortality prediction using immune landscape between 2021 and 2022 in Japan","authors":"Taishi Kayano , Misaki Sasanami , Hiroshi Nishiura","doi":"10.1016/j.jvacx.2024.100547","DOIUrl":"10.1016/j.jvacx.2024.100547","url":null,"abstract":"<div><h3>Background</h3><p>Stringent public health and social measures against COVID-19 infection were implemented to avoid an overwhelming hospital caseload and excessive number of deaths, especially among elderly people. We analyzed population-level immunity and predicted mortality, calculated as the potential number of deaths on a given calendar date in Japan, to develop a science-based exit strategy from stringent control measures.</p></div><div><h3>Methods</h3><p>Immune proportions were inferred by age group using vaccination coverage data and the estimated number of naturally infected individuals. Immunity against symptomatic illness and death were estimated separately, allowing for inference of the immune fraction that was protected against either COVID-19-related symptomatic infection or death. By multiplying the infection fatality risk by age group for the immune fraction, the potential number of deaths was obtained.</p></div><div><h3>Results</h3><p>Accounting for a second and third dose of messenger RNA vaccine in the present-day population, approximately 155,000 potential deaths would be expected among people aged ≥ 60 years if all individuals were infected at the very end of 2022. A fourth dose (i.e., second booster) with a coverage identical to that of the third dose could reduce mortality by 60%. In all examined settings, the largest number of deaths occurred among people aged 80 years and older.</p></div><div><h3>Conclusions</h3><p>Our estimates can help policymakers understand the mortality impact of the COVID-19 epidemic in a quantitative manner and the critical importance of timely immunization so as to assist in decision making.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100547"},"PeriodicalIF":2.7,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001207/pdfft?md5=488d409c0db01b224917f3cbcbe045b6&pid=1-s2.0-S2590136224001207-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141990709","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 : 2024-08-05DOI: 10.1016/j.jvacx.2024.100546
Oliver Galgut , Fiona Ashford , Alexandra Deeks , Andeep Ghataure , Mimia Islam , Tanvir Sambhi , Yiu Wayn Ker , Christopher J.A. Duncan , Thushan I. de Silva , Susan Hopkins , Victoria Hall , Paul Klenerman , Susanna Dunachie , Alex Richter
Introduction
Health care workers (HCWs) have been at increased risk of infection during the SARS-CoV-2 pandemic and as essential workers have been prioritised for vaccination. Due to increased exposure HCW are considered a predictor of what might happen in the general population, particularly working age adults. This study aims to summarise effect of vaccination in this ‘at risk’ cohort.
Methods
Ovid MEDLINE and Embase were searched, and 358 individual articles were identified. Of these 49 met the inclusion criteria for review and 14 were included in a meta-analysis.
Results
Participants included were predominantly female and working age. Median time to infection was 51 days. Reported vaccine effectiveness against infection, symptomatic infection, and infection requiring hospitalisation were between 5 and 100 %, 34 and 100 %, and 65 and 100 % (respectively). No vaccinated HCW deaths were recorded in any study. Pooled estimates of protection against infection, symptomatic infection, and hospitalisation were, respectively, 84.7 % (95 % CI 72.6–91.5 %, p < 0.0001), 86.0 % (95 % CI 67.2 %-94.0 %; p < 0.0001), and 96.1 % (95 % CI 90.4 %-98.4 %). Waning protection against infection was reported by four studies, although protection against hospitalisation for severe infection persists for at least 6 months post vaccination.
Conclusions
Vaccination against SARS-CoV2 in HCWs is protective against infection, symptomatic infection, and hospitalisation. Waning protection is reported but this awaits more mature studies to understand durability more clearly. This study is limited by varying non-pharmacological responses to COVID-19 between included studies, a predominantly female and working age population, and limited information on asymptomatic transmission or long COVID protection.
{"title":"COVID-19 vaccines are effective at preventing symptomatic and severe infection among healthcare workers: A clinical review","authors":"Oliver Galgut , Fiona Ashford , Alexandra Deeks , Andeep Ghataure , Mimia Islam , Tanvir Sambhi , Yiu Wayn Ker , Christopher J.A. Duncan , Thushan I. de Silva , Susan Hopkins , Victoria Hall , Paul Klenerman , Susanna Dunachie , Alex Richter","doi":"10.1016/j.jvacx.2024.100546","DOIUrl":"10.1016/j.jvacx.2024.100546","url":null,"abstract":"<div><h3>Introduction</h3><p>Health care workers (HCWs) have been at increased risk of infection during the SARS-CoV-2 pandemic and as essential workers have been prioritised for vaccination. Due to increased exposure HCW are considered a predictor of what might happen in the general population, particularly working age adults. This study aims to summarise effect of vaccination in this ‘at risk’ cohort.</p></div><div><h3>Methods</h3><p>Ovid MEDLINE and Embase were searched, and 358 individual articles were identified. Of these 49 met the inclusion criteria for review and 14 were included in a meta-analysis.</p></div><div><h3>Results</h3><p>Participants included were predominantly female and working age. Median time to infection was 51 days. Reported vaccine effectiveness against infection, symptomatic infection, and infection requiring hospitalisation were between 5 and 100 %, 34 and 100 %, and 65 and 100 % (respectively). No vaccinated HCW deaths were recorded in any study. Pooled estimates of protection against infection, symptomatic infection, and hospitalisation were, respectively, 84.7 % (95 % CI 72.6–91.5 %, <em>p</em> < 0.0001), 86.0 % (95 % CI 67.2 %-94.0 %; p < 0.0001), and 96.1 % (95 % CI 90.4 %-98.4 %). Waning protection against infection was reported by four studies, although protection against hospitalisation for severe infection persists for at least 6 months post vaccination.</p></div><div><h3>Conclusions</h3><p>Vaccination against SARS-CoV2 in HCWs is protective against infection, symptomatic infection, and hospitalisation. Waning protection is reported but this awaits more mature studies to understand durability more clearly. This study is limited by varying non-pharmacological responses to COVID-19 between included studies, a predominantly female and working age population, and limited information on asymptomatic transmission or long COVID protection.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100546"},"PeriodicalIF":2.7,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001190/pdfft?md5=1f7b30485082d7dbf6452ef88042fb7f&pid=1-s2.0-S2590136224001190-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141963408","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}
The Herpes Zoster (HZ) poses a significant public health threat, leading to morbidity and occasional mortality in unvaccinated adults aged 50 and older. With over 95 % of individuals in this age group globally having prior exposure to Varicella-Zoster Virus, a substantial portion of the world’s population is susceptible to developing HZ. Without vaccination, individuals reaching 85 years face a 50 % lifetime risk of HZ. Organizational and logistical barriers further hinder vaccination efforts, involving complexities in cost management, demanding vaccine storage requirements, supply limitations, distribution challenges, absence of a streamlined status collection system, and healthcare system deficiencies.
Methods
A systematic review was conducted on the studies that examined the logistical and organizational barriers to HZ vaccination among frail and older adults, aligning with the PRISMA guidelines. Eligibility criteria focus on English studies in Europe, excluding pediatric or irrelevant populations. Rayyan AI was used for data extraction, and bias was assessed using the AXIS tool.
Results
After excluding 841 based on titles and abstracts, 22 publications were selected. A thorough analysis identified 4 studies meeting inclusion criteria, conducted between 2009 and 2022, unveiling several barriers on HZ vaccination: challenges with healthcare professionals, obstacles related to patients’ perceptions and knowledge, difficulties in accessibility, structural issues, social dynamics.
Conclusions
The study represents a comprehensive examination, emphasizing the need for targeted interventions to overcome these barriers. The findings underscore the urgency of addressing these challenges to enhance vaccination rates and mitigate the public health burden associated with HZ.
{"title":"Logistic and organizational barriers to herpes zoster vaccination in europe: A systematic review","authors":"Michele Sorrentino , Alessandro Belpiede , Claudio Fiorilla , Michelangelo Mercogliano , Maria Triassi , Raffale Palladino","doi":"10.1016/j.jvacx.2024.100544","DOIUrl":"10.1016/j.jvacx.2024.100544","url":null,"abstract":"<div><h3>Background</h3><p>The Herpes Zoster (HZ) poses a significant public health threat, leading to morbidity and occasional mortality in unvaccinated adults aged 50 and older. With over 95 % of individuals in this age group globally having prior exposure to Varicella-Zoster Virus, a substantial portion of the world’s population is susceptible to developing HZ. Without vaccination, individuals reaching 85 years face a 50 % lifetime risk of HZ. Organizational and logistical barriers further hinder vaccination efforts, involving complexities in cost management, demanding vaccine storage requirements, supply limitations, distribution challenges, absence of a streamlined status collection system, and healthcare system deficiencies.</p></div><div><h3>Methods</h3><p>A systematic review was conducted on the studies that examined the logistical and organizational barriers to HZ vaccination among frail and older adults, aligning with the PRISMA guidelines. Eligibility criteria focus on English studies in Europe, excluding pediatric or irrelevant populations. Rayyan AI was used for data extraction, and bias was assessed using the AXIS tool.</p></div><div><h3>Results</h3><p>After excluding 841 based on titles and abstracts, 22 publications were selected. A thorough analysis identified 4 studies meeting inclusion criteria, conducted between 2009 and 2022, unveiling several barriers on HZ vaccination: challenges with healthcare professionals, obstacles related to patients’ perceptions and knowledge, difficulties in accessibility, structural issues, social dynamics.</p></div><div><h3>Conclusions</h3><p>The study represents a comprehensive examination, emphasizing the need for targeted interventions to overcome these barriers. The findings underscore the urgency of addressing these challenges to enhance vaccination rates and mitigate the public health burden associated with HZ.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100544"},"PeriodicalIF":2.7,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001177/pdfft?md5=f4ee87863946d561157a0701ed2ab1b1&pid=1-s2.0-S2590136224001177-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141962760","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 : 2024-08-03DOI: 10.1016/j.jvacx.2024.100543
Nathaniel A. Rader , Katherine S. Lee , Andrea N. Loes , Olivia A. Miller-Stump , Melissa Cooper , Ting Y. Wong , Dylan T. Boehm , Mariette Barbier , Justin R. Bevere , F. Heath Damron
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), rapidly spread across the globe in 2019. With the emergence of the Omicron variant, COVID-19 shifted into an endemic phase. Given the anticipated rise in cases during the fall and winter seasons, the strategy of implementing seasonal booster vaccines for COVID-19 is becoming increasingly valuable to protect public health. This practice already exists for seasonal influenza vaccines to combat annual influenza seasons. Our goal was to investigate an easily modifiable vaccine platform for seasonal use against SARS-CoV-2. In this study, we evaluated the genetically modified influenza virus ΔNA(RBD) as an intranasal vaccine candidate for COVID-19. This modified virus was engineered to replace the coding sequence for the neuraminidase (NA) protein with a membrane-anchored form of the receptor binding domain (RBD) protein of SARS-CoV-2. We designed experiments to assess the protection of ΔNA(RBD) in K18-hACE2 mice using lethal (Delta) and non-lethal (Omicron) challenge models. Controls of COVID-19 mRNA vaccine and our lab’s previously described intranasal virus like particle vaccine were used as comparisons. Immunization with ΔNA(RBD) expressing ancestral RBD elicited high anti-RBD IgG levels in the serum of mice, high anti-RBD IgA in lung tissue, and improved survival after Delta variant challenge. Modifying ΔNA(RBD) to express Omicron variant RBD shifted variant-specific antibody responses and limited viral burden in the lungs of mice after Omicron variant challenge. Overall, this data suggests that ΔNA(RBD) could be an effective intranasal vaccine platform that generates mucosal and systemic immunity towards SARS-CoV-2.
{"title":"Influenza virus strains expressing SARS-CoV-2 receptor binding domain protein confer immunity in K18-hACE2 mice","authors":"Nathaniel A. Rader , Katherine S. Lee , Andrea N. Loes , Olivia A. Miller-Stump , Melissa Cooper , Ting Y. Wong , Dylan T. Boehm , Mariette Barbier , Justin R. Bevere , F. Heath Damron","doi":"10.1016/j.jvacx.2024.100543","DOIUrl":"10.1016/j.jvacx.2024.100543","url":null,"abstract":"<div><p>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), rapidly spread across the globe in 2019. With the emergence of the Omicron variant, COVID-19 shifted into an endemic phase. Given the anticipated rise in cases during the fall and winter seasons, the strategy of implementing seasonal booster vaccines for COVID-19 is becoming increasingly valuable to protect public health. This practice already exists for seasonal influenza vaccines to combat annual influenza seasons. Our goal was to investigate an easily modifiable vaccine platform for seasonal use against SARS-CoV-2. In this study, we evaluated the genetically modified influenza virus ΔNA(RBD) as an intranasal vaccine candidate for COVID-19. This modified virus was engineered to replace the coding sequence for the neuraminidase (NA) protein with a membrane-anchored form of the receptor binding domain (RBD) protein of SARS-CoV-2. We designed experiments to assess the protection of ΔNA(RBD) in K18-hACE2 mice using lethal (Delta) and non-lethal (Omicron) challenge models. Controls of COVID-19 mRNA vaccine and our lab’s previously described intranasal virus like particle vaccine were used as comparisons. Immunization with ΔNA(RBD) expressing ancestral RBD elicited high anti-RBD IgG levels in the serum of mice, high anti-RBD IgA in lung tissue, and improved survival after Delta variant challenge. Modifying ΔNA(RBD) to express Omicron variant RBD shifted variant-specific antibody responses and limited viral burden in the lungs of mice after Omicron variant challenge. Overall, this data suggests that ΔNA(RBD) could be an effective intranasal vaccine platform that generates mucosal and systemic immunity towards SARS-CoV-2.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100543"},"PeriodicalIF":2.7,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001165/pdfft?md5=3b5fb587e718d82fcf1fa3214035e3db&pid=1-s2.0-S2590136224001165-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141963409","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 : 2024-08-03DOI: 10.1016/j.jvacx.2024.100545
Sang-Jin Park , Joung‐Wook Seo , Kang-Hyun Han , Byoung-Seok Lee , Chanyeong Lee , Young Bong Kim , Kyong-Cheol Ko , Yong-Bum Kim
The coronavirus disease 2019 (COVID-19) emerged as a major global health crisis, posing significant health, economic, and social challenges. Vaccine development has been a crucial response to the severe-acute-respiratory-syndrome-related coronavirus-2 pandemic owing to the critical role of immunization in controlling infectious diseases, leading to the expedited development of several effective vaccines. Although mRNA platform-based COVID-19 vaccines authorized under emergency-use authorization have been administered globally, concerns regarding the vaccines have increased owing to the occurrence of various side effects. The present study aimed to evaluate the safety of a non-replicating recombinant baculovirus expressing the human endogenous retrovirus envelope gene (AcHERV) vaccine encoding SARS-CoV-2 antigens. Owing to the limited number of existing safety pharmacology studies on AcHERV as a viral vector vaccine, we conducted neurobehavior (Modified Irwin’s Test), body temperature, and respiratory function studies in rats and cardiovascular system studies in male beagle dogs, which were administered the AcHERV-COVID-19 vaccine using telemetry. The safety assessment revealed no significant toxicological alterations. However, in rats, both sexes administered with the AcHERV-COVID-19 vaccine exhibited a temporary increase in body temperature, which normalized or showed signs of recovery. In conclusion, AcHERV-COVID-19 demonstrates a sufficient safety profile that supports its potential evaluation in future clinical trials.
{"title":"Safety pharmacology of human endogenous retrovirus-enveloped baculoviral DNA vaccines against SARS-CoV-2 in Sprague-Dawley rats and beagle dogs","authors":"Sang-Jin Park , Joung‐Wook Seo , Kang-Hyun Han , Byoung-Seok Lee , Chanyeong Lee , Young Bong Kim , Kyong-Cheol Ko , Yong-Bum Kim","doi":"10.1016/j.jvacx.2024.100545","DOIUrl":"10.1016/j.jvacx.2024.100545","url":null,"abstract":"<div><p>The coronavirus disease 2019 (COVID-19) emerged as a major global health crisis, posing significant health, economic, and social challenges. Vaccine development has been a crucial response to the severe-acute-respiratory-syndrome-related coronavirus-2 pandemic owing to the critical role of immunization in controlling infectious diseases, leading to the expedited development of several effective vaccines. Although mRNA platform-based COVID-19 vaccines authorized under emergency-use authorization have been administered globally, concerns regarding the vaccines have increased owing to the occurrence of various side effects. The present study aimed to evaluate the safety of a non-replicating recombinant baculovirus expressing the human endogenous retrovirus envelope gene (AcHERV) vaccine encoding SARS-CoV-2 antigens. Owing to the limited number of existing safety pharmacology studies on AcHERV as a viral vector vaccine, we conducted neurobehavior (Modified Irwin’s Test), body temperature, and respiratory function studies in rats and cardiovascular system studies in male beagle dogs, which were administered the AcHERV-COVID-19 vaccine using telemetry. The safety assessment revealed no significant toxicological alterations. However, in rats, both sexes administered with the AcHERV-COVID-19 vaccine exhibited a temporary increase in body temperature, which normalized or showed signs of recovery. In conclusion, AcHERV-COVID-19 demonstrates a sufficient safety profile that supports its potential evaluation in future clinical trials.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100545"},"PeriodicalIF":2.7,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001189/pdfft?md5=f8a5cad510f471864968f8b33d6d2177&pid=1-s2.0-S2590136224001189-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141953151","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 : 2024-08-02DOI: 10.1016/j.jvacx.2024.100527
Mohammad Tanashat , Obieda Altobaishat , Abdulrahman Sharaf , Mostafa Hossam El Din Moawad , Mohammad Al-Jafari , Abdulqadir J. Nashwan
Background
Prevention and treatment of the monkeypox virus (Mpox) remain challenging in areas where it is endemic. This systematic review and meta-analysis aimed to collect this information from various studies in one study to give a comprehensive view of people's opinions, fears, and behaviors about this virus.
Methods
We searched PubMed, Scopus, Web of Science, the Cochrane Library, and Google Scholar for descriptive cross-sectional study designs conducted in 2022 and 2023 addressing knowledge, attitude, perception, preparedness, willingness to get vaccinated, and practices against Mpox infection.
Results
Among the included studies, 16 studies assessed the level of knowledge of study participants regarding Mpox with a total of 9066 participants. Among them, 4222 (46.6 %) were reported to have good knowledge, and 4844 (53.4%) were reported to have poor knowledge about Mpox. Regarding willingness to get vaccinated against Mpox, 14 studies with a total of 10,696 participants were included. Among them, 7006 (65 %) were willing to get vaccinated while 3690 (35 %) weren’t willing to be vaccinated.
Conclusion
Knowledge about Mpox should be increased and awareness should be spread regarding the importance of preventive measures such as vaccination to protect the population from another COVID-19-like pandemic.
{"title":"Assessment of the knowledge, attitude, and perception of the world's population towards monkeypox and its vaccines: A systematic review and descriptive analysis of cross-sectional studies","authors":"Mohammad Tanashat , Obieda Altobaishat , Abdulrahman Sharaf , Mostafa Hossam El Din Moawad , Mohammad Al-Jafari , Abdulqadir J. Nashwan","doi":"10.1016/j.jvacx.2024.100527","DOIUrl":"10.1016/j.jvacx.2024.100527","url":null,"abstract":"<div><h3>Background</h3><p>Prevention and treatment of the monkeypox virus (Mpox) remain challenging in areas where it is endemic. This systematic review and meta-analysis aimed to collect this information from various studies in one study to give a comprehensive view of people's opinions, fears, and behaviors about this virus.</p></div><div><h3>Methods</h3><p>We searched PubMed, Scopus, Web of Science, the Cochrane Library, and Google Scholar for descriptive cross-sectional study designs conducted in 2022 and 2023 addressing knowledge, attitude, perception, preparedness, willingness to get vaccinated, and practices against Mpox infection.</p></div><div><h3>Results</h3><p>Among the included studies, 16 studies assessed the level of knowledge of study participants regarding Mpox with a total of 9066 participants. Among them, 4222 (46.6 %) were reported to have good knowledge, and 4844 (53.4%) were reported to have poor knowledge about Mpox. Regarding willingness to get vaccinated against Mpox, 14 studies with a total of 10,696 participants were included. Among them, 7006 (65 %) were willing to get vaccinated while 3690 (35 %) weren’t willing to be vaccinated.</p></div><div><h3>Conclusion</h3><p>Knowledge about Mpox should be increased and awareness should be spread regarding the importance of preventive measures such as vaccination to protect the population from another COVID-19-like pandemic.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100527"},"PeriodicalIF":2.7,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001001/pdfft?md5=7ed49664bd31d328604d9baf4a9393c5&pid=1-s2.0-S2590136224001001-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141953152","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 : 2024-08-01DOI: 10.1016/j.jvacx.2024.100531
Liqi Liu, Zi Li, Jia Liu, Xiyan Li, Jianfang Zhou, Ning Xiao, Lei Yang, Dayan Wang
Since 2022, three human cases of a novel H3N8 avian influenza virus infection have been reported in three provinces in China. Specific vaccines are important means of preparing for the potential influenza pandemic. Thus, H3N8 viruses [A/Henan/cnic410/2022 (HN410) and A/Changsha/1000/2022(CS1000)] were isolated from the infected patients as prototype viruses to develop candidate vaccine viruses (CVVs) using the reverse genetics (RG) technology. Five reassortant viruses with different HA and NA combinations were constructed based on the two viruses to get a high-yield and safe CVV. The results showed that all viruses had similar antigenicity but different growth characteristics. Reassortant viruses carrying NA from CS1000 exhibited better growth ability and NA enzyme activity than the ones carrying HN410 NA. Furthermore, the NA gene of CS1000 had one more potential N-glycosylation site at position 46 compared with HN410. The substitution of position 46 showed that adding or removing N-glycosylation sites to different reassortant viruses had different effects on growth ability. A reassortant virus carrying HN410 HA and CS1000 NA with high growth ability was selected as a CVV, which met the requirements for a CVV. These data suggest that different surface gene combinations and the presence or absence of potential N-glycosylation sites on position 46 in the NA gene affect the growth characteristics of H3N8 CVVs.
自 2022 年以来,中国三个省份报告了三例人感染新型 H3N8 禽流感病毒的病例。特异性疫苗是应对潜在流感大流行的重要手段。因此,我们从感染者身上分离出 H3N8 病毒 [A/河南/cnic410/2022(HN410)和 A/长沙/1000/2022(CS1000)],作为利用反向遗传学(RG)技术开发候选疫苗病毒(CVV)的原型病毒。以这两种病毒为基础,构建了5种不同HA和NA组合的变种病毒,以获得高产、安全的候选疫苗病毒。结果表明,所有病毒的抗原性相似,但生长特性不同。与携带 HN410 NA 的病毒相比,携带 CS1000 NA 的后裔病毒具有更好的生长能力和 NA 酶活性。此外,与 HN410 相比,CS1000 的 NA 基因在第 46 位多了一个潜在的 N-糖基化位点。第 46 位的替换表明,在不同的变种病毒中添加或去除 N-糖基化位点对其生长能力有不同的影响。一种携带 HN410 HA 和 CS1000 NA、生长能力强的重交病毒被选为 CVV,符合 CVV 的要求。这些数据表明,不同的表面基因组合以及 NA 基因第 46 位潜在 N-糖基化位点的存在与否会影响 H3N8 CVV 的生长特性。
{"title":"Effects of different HA and NA gene combinations on the growth characteristics of the H3N8 influenza candidate vaccine virus","authors":"Liqi Liu, Zi Li, Jia Liu, Xiyan Li, Jianfang Zhou, Ning Xiao, Lei Yang, Dayan Wang","doi":"10.1016/j.jvacx.2024.100531","DOIUrl":"10.1016/j.jvacx.2024.100531","url":null,"abstract":"<div><p>Since 2022, three human cases of a novel H3N8 avian influenza virus infection have been reported in three provinces in China. Specific vaccines are important means of preparing for the potential influenza pandemic. Thus, H3N8 viruses [A/Henan/cnic410/2022 (HN410) and A/Changsha/1000/2022(CS1000)] were isolated from the infected patients as prototype viruses to develop candidate vaccine viruses (CVVs) using the reverse genetics (RG) technology. Five reassortant viruses with different HA and NA combinations were constructed based on the two viruses to get a high-yield and safe CVV. The results showed that all viruses had similar antigenicity but different growth characteristics. Reassortant viruses carrying NA from CS1000 exhibited better growth ability and NA enzyme activity than the ones carrying HN410 NA. Furthermore, the NA gene of CS1000 had one more potential N-glycosylation site at position 46 compared with HN410. The substitution of position 46 showed that adding or removing N-glycosylation sites to different reassortant viruses had different effects on growth ability. A reassortant virus carrying HN410 HA and CS1000 NA with high growth ability was selected as a CVV, which met the requirements for a CVV. These data suggest that different surface gene combinations and the presence or absence of potential N-glycosylation sites on position 46 in the NA gene affect the growth characteristics of H3N8 CVVs.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100531"},"PeriodicalIF":2.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001049/pdfft?md5=f7cdf2466fc67d18eea671a1e35c55b6&pid=1-s2.0-S2590136224001049-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141839083","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 : 2024-08-01DOI: 10.1016/j.jvacx.2024.100526
Pawan Kumar , Arindam Ray , Amrita Kumari , Amanjot Kaur , Rhythm Hora , Kapil Singh , Rashmi Mehra , Seema S Koshal , Shipra Verma , Syed F. Quadri , Arup Deb Roy
Background
India became the first country in the WHO South-East Asia Region (SEAR) to introduce the rotavirus vaccine (RVV) in the Universal immunization programme (UIP) in 2016 with nationwide expansion by 2019. It was a landmark move to reduce the diarrheal disease burden in under-five children. To assess the implementation process of introduction of RVV, Post Introduction Evaluation (PIE) was conducted in March 2022.
Methods
The evaluation was conducted across 14 states, 28 districts and 28 health facilities to obtain a nationwide geographical inclusion. Stakeholders involved in program decision-making, planning, training, vaccine delivery, logistics, and communication from all levels (National, state, district, health facility, health worker, caregiver) were interviewed using standardized data collection tool for PIE (adapted from the standard WHO PIE questionnaire) and scripted on a digital tool.
Results
A total of 260 interviews were conducted. Political willingness, well-planned preparedness activities, securing vaccines timely, strong supply chain monitoring, availability of domestic RVV products, quality trainings and intense communication activities were the key factors identified for the successful RVV introduction. Key activities during the introduction included cold chain space assessment, trainings of healthcare workforce, dissemination of job aids, updation of recording & reporting formats and strengthening of AEFI surveillance. Lack of community awareness for immunization in a few areas, fear of AEFI amongst some caregivers and local issues with Alternate Vaccine Delivery (AVD) were some reported challenges in achieving high coverage for RVV.
Conclusions
Overall, the nationwide roll-out of RVV was smooth and the vaccine has been well-accepted in the community. The assessment emphasizes on having a well-strategized operational and communication planning, which is very crucial for any new vaccine introduction.
{"title":"Post-introduction evaluation (PIE) of rotavirus vaccine in India","authors":"Pawan Kumar , Arindam Ray , Amrita Kumari , Amanjot Kaur , Rhythm Hora , Kapil Singh , Rashmi Mehra , Seema S Koshal , Shipra Verma , Syed F. Quadri , Arup Deb Roy","doi":"10.1016/j.jvacx.2024.100526","DOIUrl":"10.1016/j.jvacx.2024.100526","url":null,"abstract":"<div><h3>Background</h3><p>India became the first country in the WHO South-East Asia Region (SEAR) to introduce the rotavirus vaccine (RVV) in the Universal immunization programme (UIP) in 2016 with nationwide expansion by 2019. It was a landmark move to reduce the diarrheal disease burden in under-five children. To assess the implementation process of introduction of RVV, Post Introduction Evaluation (PIE) was conducted in March 2022.</p></div><div><h3>Methods</h3><p>The evaluation was conducted across 14 states, 28 districts and 28 health facilities to obtain a nationwide geographical inclusion. Stakeholders involved in program decision-making, planning, training, vaccine delivery, logistics, and communication from all levels (National, state, district, health facility, health worker, caregiver) were interviewed using standardized data collection tool for PIE (adapted from the standard WHO PIE questionnaire) and scripted on a digital tool.</p></div><div><h3>Results</h3><p>A total of 260 interviews were conducted. Political willingness, well-planned preparedness activities, securing vaccines timely, strong supply chain monitoring, availability of domestic RVV products, quality trainings and intense communication activities were the key factors identified for the successful RVV introduction. Key activities during the introduction included cold chain space assessment, trainings of healthcare workforce, dissemination of job aids, updation of recording & reporting formats and strengthening of AEFI surveillance. Lack of community awareness for immunization in a few areas, fear of AEFI amongst some caregivers and local issues with Alternate Vaccine Delivery (AVD) were some reported challenges in achieving high coverage for RVV.</p></div><div><h3>Conclusions</h3><p>Overall, the nationwide roll-out of RVV was smooth and the vaccine has been well-accepted in the community. The assessment emphasizes on having a well-strategized operational and communication planning, which is very crucial for any new vaccine introduction.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100526"},"PeriodicalIF":2.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000998/pdfft?md5=333ec60cdd772a04b8519154e93a1ca3&pid=1-s2.0-S2590136224000998-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141840668","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}