Thailand incorporated the hepatitis B (HepB) vaccine into the infant combination vaccine known as pentavalent wP-containing vaccines (DTwP-HB-Hib) and hexavalent aP-containing vaccines (DTaP-IPV-HB-Hib). We followed healthy children from the clinical trial (ClinicalTrials.gov NCT02408926) in which children were randomly assigned to receive either pentavalent or hexavalent vaccines for their primary series (administered at 2, 4, and 6 months) and first booster vaccination (at 18 months), following the monovalent HepB vaccine at birth. Blood samples were collected to evaluate the persistence of hepatitis B surface antibody (anti-HBs) at 3, 4, 5, 6 and 7 years of age. The results showed that at 7 years of age, a higher percentage of children in the hexavalent group maintained anti-HBs levels ≥ 10 mIU/mL compared to those in the pentavalent group (86.9 % vs. 59.7 %). This study showed good persistence of anti-HBs among hexavalent-vaccinated children 5.5 years after the last dose of the HepB vaccine.
{"title":"Persistence of hepatitis B surface antibody until 7 years of age following administration of hexavalent and pentavalent vaccines in children at 2, 4, 6, and 18 months","authors":"Nasamon Wanlapakorn , Nasiri Sarawanangkoor , Donchida Srimuan , Thaksaporn Thatsanathorn , Sirapa Klinfueng , Yong Poovorawan","doi":"10.1016/j.jvacx.2024.100561","DOIUrl":"10.1016/j.jvacx.2024.100561","url":null,"abstract":"<div><div>Thailand incorporated the hepatitis B (HepB) vaccine into the infant combination vaccine known as pentavalent wP-containing vaccines (DTwP-HB-Hib) and hexavalent aP-containing vaccines (DTaP-IPV-HB-Hib). We followed healthy children from the clinical trial (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> NCT02408926) in which children were randomly assigned to receive either pentavalent or hexavalent vaccines for their primary series (administered at 2, 4, and 6 months) and first booster vaccination (at 18 months), following the monovalent HepB vaccine at birth. Blood samples were collected to evaluate the persistence of hepatitis B surface antibody (anti-HBs) at 3, 4, 5, 6 and 7 years of age. The results showed that at 7 years of age, a higher percentage of children in the hexavalent group maintained anti-HBs levels ≥ 10 mIU/mL compared to those in the pentavalent group (86.9 % vs. 59.7 %). This study showed good persistence of anti-HBs among hexavalent-vaccinated children 5.5 years after the last dose of the HepB vaccine.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100561"},"PeriodicalIF":2.7,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001347/pdfft?md5=7c1cd77360360e23dcac2e57338715fb&pid=1-s2.0-S2590136224001347-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142313017","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}
Coxsackievirus A16 (CVA16) is one of the primary pathogens that causes hand, foot, and mouth disease (HFMD) in young children. In previous studies, CVA16 vaccine development has encountered several challenges, such as inefficient replication of the CVA16 virus in present culture systems, the induction of only mild neutralizing antibody titers, and neutralizing antibodies induced by certain vaccine candidates that are unable to protect against CVA16 viral challenge. In this study, we constructed a DNA-launched CVA16 infectious clone (CVA16ic) based on the genomic sequence of the CVA16 N5079 strain to minimize interference from viral quasispecies. The biochemical properties of this CVA16ic strain were similar to those of its parental strain. Serum-free HEK293A suspension cells, which produced higher virus titers than Vero cells, were demonstrated to improve CVA16 production yields. In addition, our study showed that inactivated EV-A71 antigens could enhance the immunogenicity of inactivated CVA16 mature/full particles (F-particles), suggesting that a bivalent CVA16 and EV-A71 vaccine may be an effective strategy for CVA16 vaccine development. These findings are expected to provide novel strategies and accelerate the development of bivalent HFMD vaccines.
{"title":"Enhanced production of recombinant coxsackievirus A16 using a serum-free HEK293A suspension culture system for bivalent enterovirus vaccine development","authors":"Yi-An Chen , Yu-Sheng Shen , Chih-Yeu Fang , Ting-Ting Chan , Shang-Rung Wu , Jen-Ren Wang , Suh-Chin Wu , Chia-Chyi Liu","doi":"10.1016/j.jvacx.2024.100559","DOIUrl":"10.1016/j.jvacx.2024.100559","url":null,"abstract":"<div><div>Coxsackievirus A16 (CVA16) is one of the primary pathogens that causes hand, foot, and mouth disease (HFMD) in young children. In previous studies, CVA16 vaccine development has encountered several challenges, such as inefficient replication of the CVA16 virus in present culture systems, the induction of only mild neutralizing antibody titers, and neutralizing antibodies induced by certain vaccine candidates that are unable to protect against CVA16 viral challenge. In this study, we constructed a DNA-launched CVA16 infectious clone (CVA16ic) based on the genomic sequence of the CVA16 N5079 strain to minimize interference from viral quasispecies. The biochemical properties of this CVA16ic strain were similar to those of its parental strain. Serum-free HEK293A suspension cells, which produced higher virus titers than Vero cells, were demonstrated to improve CVA16 production yields. In addition, our study showed that inactivated EV-A71 antigens could enhance the immunogenicity of inactivated CVA16 mature/full particles (F-particles), suggesting that a bivalent CVA16 and EV-A71 vaccine may be an effective strategy for CVA16 vaccine development. These findings are expected to provide novel strategies and accelerate the development of bivalent HFMD vaccines.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100559"},"PeriodicalIF":2.7,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001323/pdfft?md5=a8fd1194384d52a6b833966539915481&pid=1-s2.0-S2590136224001323-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142312975","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 : 2024-09-18DOI: 10.1016/j.jvacx.2024.100557
Akim N. Bwanali , Petro Liundi , Adriano F. Lubanga , Samuel L. Mpinganjira , Luis A. Gadama
Introduction
Malawi is one of the countries enduring an enormous burden of cervical cancer. Human Papillomavirus (HPV) vaccination offers a feasible and effective tool for reducing the burden. Such a prospect however, is being impeded by low uptake rates of the HPV vaccine in the country. This study, therefore, sought to identify barriers to caregiver acceptance of the HPV vaccine for their female children in Chileka, Blantyre, Malawi and to establish the consequential willingness to vaccinate their children.
Methodology
A cross-sectional study was conducted using qualitative methods. We conducted 6 Focus Group Discussions (FGDs) with 4 groups of women and 2 groups of men in 4 villages located in a semi-urban area, Chileka, Blantyre. The guiding questionnaire was designed to draw out two main outcomes: barriers to caregiver acceptance of the HPV vaccine and willingness to vaccinate children. The data was analysed by thematic analysis by an inductive approach using NVivo software version 11.
Results
Lack of knowledge on cervical cancer and HPV vaccination coupled with numerous misconceptions are the main barriers discouraging the population from accepting the HPV vaccine. Consequently, there was little desire to get their children vaccinated against HPV. Though responsibility to get the children vaccinated was mainly attributed to women, men argued that they need to have a final say in their children’s vaccination.
Conclusion
In the wake of the revealed barriers and low acceptance of the HPV vaccine, it is imperative to organize effective and sustainable awareness programmes for the improvement of the HPV vaccine’s uptake.
{"title":"Caregiver acceptance of human papillomavirus vaccine for their female children in Chileka, Blantyre, Malawi","authors":"Akim N. Bwanali , Petro Liundi , Adriano F. Lubanga , Samuel L. Mpinganjira , Luis A. Gadama","doi":"10.1016/j.jvacx.2024.100557","DOIUrl":"10.1016/j.jvacx.2024.100557","url":null,"abstract":"<div><h3>Introduction</h3><p>Malawi is one of the countries enduring an enormous burden of cervical cancer. Human Papillomavirus (HPV) vaccination offers a feasible and effective tool for reducing the burden. Such a prospect however, is being impeded by low uptake rates of the HPV vaccine in the country. This study, therefore, sought to identify barriers to caregiver acceptance of the HPV vaccine for their female children in Chileka, Blantyre, Malawi and to establish the consequential willingness to vaccinate their children.</p></div><div><h3>Methodology</h3><p>A cross-sectional study was conducted using qualitative methods. We conducted 6 Focus Group Discussions (FGDs) with 4 groups of women and 2 groups of men in 4 villages located in a semi-urban area, Chileka, Blantyre. The guiding questionnaire was designed to draw out two main outcomes: barriers to caregiver acceptance of the HPV vaccine and willingness to vaccinate children. The data was analysed by thematic analysis by an inductive approach using NVivo software version 11.</p></div><div><h3>Results</h3><p>Lack of knowledge on cervical cancer and HPV vaccination coupled with numerous misconceptions are the main barriers discouraging the population from accepting the HPV vaccine. Consequently, there was little desire to get their children vaccinated against HPV. Though responsibility to get the children vaccinated was mainly attributed to women, men argued that they need to have a final say in their children’s vaccination.</p></div><div><h3>Conclusion</h3><p>In the wake of the revealed barriers and low acceptance of the HPV vaccine, it is imperative to organize effective and sustainable awareness programmes for the improvement of the HPV vaccine’s uptake.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100557"},"PeriodicalIF":2.7,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S259013622400130X/pdfft?md5=2814f9717f2b88fcd8593a492a2db96a&pid=1-s2.0-S259013622400130X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142272099","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}
Adrenocorticotropic hormone (ACTH) therapy is effective for infantile epileptic spasms syndrome (IESS) but can induce immunosuppression. In Japan, Bacille Calmette-Guérin (BCG) vaccination, modified in 2013 to reduce osteitis/osteomyelitis risk, coincides with the peak onset age of IESS. This raises concerns about infection risks when administering ACTH therapy post-vaccination. To evaluate the impact of BCG vaccination timing on treatment decisions, we retrospectively reviewed the medical records of 86 IESS patients at our hospital (1996–2020). Infants who received ACTH therapy within eight weeks of BCG vaccination experienced no serious adverse events. Four patients deferred or opted out of ACTH therapy, with seizure remission taking 2–15 weeks. The overlap between IESS onset and BCG vaccination period presents clinical challenges in determining the appropriate timing for ACTH therapy. Further epidemiological and immunological research is needed to clarify the relationship between ACTH therapy and BCG-associated adverse events and to optimize treatment strategies and vaccination schedules.
{"title":"Impact of Bacille Calmette-Guérin vaccination on the therapeutic schedule of infantile epileptic spasms syndrome: A 25-year Japanese single-center survey","authors":"Hikaru Kobayashi , Hirofumi Inoue , Takeshi Matsushige , Madoka Hoshide , Fumitaka Kohno , Ippei Hidaka , Shunji Hasegawa","doi":"10.1016/j.jvacx.2024.100558","DOIUrl":"10.1016/j.jvacx.2024.100558","url":null,"abstract":"<div><p>Adrenocorticotropic hormone (ACTH) therapy is effective for infantile epileptic spasms syndrome (IESS) but can induce immunosuppression. In Japan, Bacille Calmette-Guérin (BCG) vaccination, modified in 2013 to reduce osteitis/osteomyelitis risk, coincides with the peak onset age of IESS. This raises concerns about infection risks when administering ACTH therapy post-vaccination. To evaluate the impact of BCG vaccination timing on treatment decisions, we retrospectively reviewed the medical records of 86 IESS patients at our hospital (1996–2020). Infants who received ACTH therapy within eight weeks of BCG vaccination experienced no serious adverse events. Four patients deferred or opted out of ACTH therapy, with seizure remission taking 2–15 weeks. The overlap between IESS onset and BCG vaccination period presents clinical challenges in determining the appropriate timing for ACTH therapy. Further epidemiological and immunological research is needed to clarify the relationship between ACTH therapy and BCG-associated adverse events and to optimize treatment strategies and vaccination schedules.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100558"},"PeriodicalIF":2.7,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001311/pdfft?md5=8600e016d83bced5f39e6f116a7bc6b7&pid=1-s2.0-S2590136224001311-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142272231","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 : 2024-09-13DOI: 10.1016/j.jvacx.2024.100554
Joukje E. Willemsen , Femke S. Vernooij , Farina L. Shaaban , Chilufya Chikoti , Louis J. Bont , Julia Drylewicz , the RSV GOLD study group
The current understanding of the RSV-related mortality age distribution in low- and lower-middle-income countries (LMICs) relies on a limited number of disease incidence studies reporting wide age bands, and lacking specificity to Gavi-eligible countries. Understanding the age distribution of RSV-related deaths is crucial for the implementation of RSV interventions in LMICs that rely on support from Gavi. This study aims to provide the age profile of RSV mortality specifically in Gavi-eligible countries.
Utilizing data from the RSV GOLD project, an ongoing global online mortality registry focusing on children under the age of 5 with laboratory-confirmed RSV infection, we employed two models (Complete Data Model and Prospective Data Model) to estimate the age profiles. To mitigate biases related to age group representation, we applied post-stratification weighting in our analysis.
We included 423 pediatric deaths, including 145 from the community, under 2 years of age from 15 Gavi-eligible countries. Both models identified a peak age at 1 month and found that the majority of RSV-related mortality cases (59–77 %) from Gavi-eligible countries occur before 6 months of life. However, the models exhibited disparities in other age-related metrics. We present fitted age-at-time-of-death probability distributions to aid impact and cost-effectiveness studies.
We expect that implementing infant RSV immunization strategies, such as maternal vaccination or infant immunoprophylaxis, will have high impact on RSV-related mortality in Gavi-eligible countries. The divergent results from the two models underscore the importance of carefully considering potential biases in retrospective and surveillance data when interpreting the age profile of RSV mortality cases in future research.
{"title":"Characteristics of inpatient and outpatient respiratory syncytial virus mortality in Gavi-eligible countries","authors":"Joukje E. Willemsen , Femke S. Vernooij , Farina L. Shaaban , Chilufya Chikoti , Louis J. Bont , Julia Drylewicz , the RSV GOLD study group","doi":"10.1016/j.jvacx.2024.100554","DOIUrl":"10.1016/j.jvacx.2024.100554","url":null,"abstract":"<div><p>The current understanding of the RSV-related mortality age distribution in low- and lower-middle-income countries (LMICs) relies on a limited number of disease incidence studies reporting wide age bands, and lacking specificity to Gavi-eligible countries. Understanding the age distribution of RSV-related deaths is crucial for the implementation of RSV interventions in LMICs that rely on support from Gavi. This study aims to provide the age profile of RSV mortality specifically in Gavi-eligible countries.</p><p>Utilizing data from the RSV GOLD project, an ongoing global online mortality registry focusing on children under the age of 5 with laboratory-confirmed RSV infection, we employed two models (Complete Data Model and Prospective Data Model) to estimate the age profiles. To mitigate biases related to age group representation, we applied post-stratification weighting in our analysis.</p><p>We included 423 pediatric deaths, including 145 from the community, under 2 years of age from 15 Gavi-eligible countries. Both models identified a peak age at 1 month and found that the majority of RSV-related mortality cases (59–77 %) from Gavi-eligible countries occur before 6 months of life. However, the models exhibited disparities in other age-related metrics. We present fitted age-at-time-of-death probability distributions to aid impact and cost-effectiveness studies.</p><p>We expect that implementing infant RSV immunization strategies, such as maternal vaccination or infant immunoprophylaxis, will have high impact on RSV-related mortality in Gavi-eligible countries. The divergent results from the two models underscore the importance of carefully considering potential biases in retrospective and surveillance data when interpreting the age profile of RSV mortality cases in future research.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100554"},"PeriodicalIF":2.7,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S259013622400127X/pdfft?md5=850fa51577397dbda17e74955f743f72&pid=1-s2.0-S259013622400127X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142232615","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}
Understanding the waning of immunity after booster vaccinations is important to identify which immune-low populations should be prioritized.
Methods
We investigated longitudinal cellular and humoral immunity after the third vaccine dose in both high- and low-cellular and humoral immunity groups at the peak immunity phase after the booster vaccination in a large community-based cohort. Blood samples were collected from 1045 participants at peak (T1: median 54 days post-third dose) and decay (T2: median 145 days post-third dose) phases to assess IgG(S), neutralizing activity, and ELISpot responses. Participants were categorized into high/low ELISpot/IgG(S) groups at T1. Cellular and humoral responses were tracked for approximately five months after the third vaccination.
Results
In total, 983 participants were included in the cohort. IgG(S) geometric mean fold change between timepoints revealed greater waning in the >79 years age group (T2/T1 fold change: 0.27) and higher IgG(S) fold change in the low-ELISpot group at T1 (T2/T1 fold change: 0.32–0.33) than in the other groups, although ELISpot geometric mean remained stable.
Conclusions
Antibody level of those who did not respond well to third dose vaccination waned rapidly than those who responded well. Evidence-based vaccine strategies are essential in preventing potential health issues caused by vaccines, including side-effects.
{"title":"Kinetics of humoral and cellular immune responses 5 months post-COVID-19 booster dose by immune response groups at the peak immunity phase: An observational historical cohort study using the Fukushima vaccination community survey","authors":"Yurie Kobashi , Takeshi Kawamura , Yuzo Shimazu , Yudai Kaneko , Yoshitaka Nishikawa , Akira Sugiyama , Yuta Tani , Aya Nakayama , Makoto Yoshida , Tianchen Zho , Chika Yamamoto , Hiroaki Saito , Morihito Takita , Masatoshi Wakui , Tatsuhiko Kodama , Masaharu Tsubokura","doi":"10.1016/j.jvacx.2024.100553","DOIUrl":"10.1016/j.jvacx.2024.100553","url":null,"abstract":"<div><h3>Background</h3><p>Understanding the waning of immunity after booster vaccinations is important to identify which immune-low populations should be prioritized.</p></div><div><h3>Methods</h3><p>We investigated longitudinal cellular and humoral immunity after the third vaccine dose in both high- and low-cellular and humoral immunity groups at the peak immunity phase after the booster vaccination in a large community-based cohort. Blood samples were collected from 1045 participants at peak (T1: median 54 days post-third dose) and decay (T2: median 145 days post-third dose) phases to assess IgG(S), neutralizing activity, and ELISpot responses. Participants were categorized into high/low ELISpot/IgG(S) groups at T1. Cellular and humoral responses were tracked for approximately five months after the third vaccination.</p></div><div><h3>Results</h3><p>In total, 983 participants were included in the cohort. IgG(S) geometric mean fold change between timepoints revealed greater waning in the >79 years age group (T2/T1 fold change: 0.27) and higher IgG(S) fold change in the low-ELISpot group at T1 (T2/T1 fold change: 0.32–0.33) than in the other groups, although ELISpot geometric mean remained stable.</p></div><div><h3>Conclusions</h3><p>Antibody level of those who did not respond well to third dose vaccination waned rapidly than those who responded well. Evidence-based vaccine strategies are essential in preventing potential health issues caused by vaccines, including side-effects.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100553"},"PeriodicalIF":2.7,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001268/pdfft?md5=91a1943ae91b3c68e8eb9a183dfe94f7&pid=1-s2.0-S2590136224001268-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142228621","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 : 2024-09-12DOI: 10.1016/j.jvacx.2024.100555
Emily Briskin , Stéphane Hans Bateyi Mustafa , Rachel Mahamba , Deka Kabunga , Janvier Kubuya , Klaudia Porten , Epicentre-MSF DRC cholera working group, Laurent Akilimali , Placide Okitayemba Welo , Anaïs Broban
Background
In 2019–2020, preventative Oral Cholera Vaccine campaigns were conducted in 24/32 non-contiguous health areas of Goma, DR Congo. In August 2022, we measured coverage and factors potentially influencing success of the delivery strategy.
Methods
We used random geo-sampled stratified cluster survey to estimate OCV coverage and assess population movement, diarrhea history, and reasons for non-vaccination.
Results
603 households were visited. Coverage with at least one dose was 46.4 % (95 %CI: 41.8–51.0), and 50.1 % (95 %CI: 45.4–54.8) in areas targeted by vaccination compared to 26.3 % (95 %CI: 19.2–34.9) in non-targeted areas. Additionally, 7.0 % of participants reported moving from outside Goma since 2019, and 5.4 % reported history of severe diarrhea. Absence and unawareness were the main reasons for non-vaccination.
Conclusion
Results suggest that targeting non-contiguous urban areas had a coverage-diluting effect. Targeting entire geographically contiguous areas, adapted distribution, and regular catch-up campaigns are operational recommendations to reach higher coverages arising from the study.
{"title":"Oral cholera vaccine coverage in Goma, Democratic Republic of the Congo, 2022, following 2019–2020 targeted preventative mass campaigns","authors":"Emily Briskin , Stéphane Hans Bateyi Mustafa , Rachel Mahamba , Deka Kabunga , Janvier Kubuya , Klaudia Porten , Epicentre-MSF DRC cholera working group, Laurent Akilimali , Placide Okitayemba Welo , Anaïs Broban","doi":"10.1016/j.jvacx.2024.100555","DOIUrl":"10.1016/j.jvacx.2024.100555","url":null,"abstract":"<div><h3>Background</h3><p>In 2019–2020, preventative Oral Cholera Vaccine campaigns were conducted in 24/32 non-contiguous health areas of Goma, DR Congo. In August 2022, we measured coverage and factors potentially influencing success of the delivery strategy.</p></div><div><h3>Methods</h3><p>We used random geo-sampled stratified cluster survey to estimate OCV coverage and assess population movement, diarrhea history, and reasons for non-vaccination.</p></div><div><h3>Results</h3><p>603 households were visited. Coverage with at least one dose was 46.4 % (95 %CI: 41.8–51.0), and 50.1 % (95 %CI: 45.4–54.8) in areas targeted by vaccination compared to 26.3 % (95 %CI: 19.2–34.9) in non-targeted areas. Additionally, 7.0 % of participants reported moving from outside Goma since 2019, and 5.4 % reported history of severe diarrhea. Absence and unawareness were the main reasons for non-vaccination.</p></div><div><h3>Conclusion</h3><p>Results suggest that targeting non-contiguous urban areas had a coverage-diluting effect. Targeting entire geographically contiguous areas, adapted distribution, and regular catch-up campaigns are operational recommendations to reach higher coverages arising from the study.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100555"},"PeriodicalIF":2.7,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001281/pdfft?md5=603a8d922ebe9636ffce586b9a2ac585&pid=1-s2.0-S2590136224001281-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142228620","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 : 2024-09-06DOI: 10.1016/j.jvacx.2024.100552
Chia-Chi Ku , Cheng-Yu Lin , Chin-Rur Yang , Yu-Chih Yang , Po-Ling Chen , Yi-Te Lin , Pei-Ru Wang , Min-Shi Lee , Shu-Mei Liang , Pei-Wen Hsiao
Background
Recent outbreaks of clade 2.3.4.4b highly pathogenic avian influenza (HPAI) H5N1 viruses in regions previously less affected since 2020 have raised global concerns. Implementing mass immunization or ring vaccination in poultry should be a countermeasure ready to contain disease outbreaks. This study focuses on developing a recombinant H5N2 vaccine based on virus-like particles (VLPs) against clade 2.3.4.4c, the predominant HPAI subclade in Taiwan since its emergence, leading to a large outbreak in 2015.
Methods
The study aimed to confirm the effectiveness of clade 2.3.4.4c H5N2 VLPs in protecting chickens and identify the best adjuvants for the VLP vaccine. We used Montanide 71VG-adjuvanted inactivated RG6 to establish the immunization protocol, followed by prime-boost H5N2-VLP immunizations. We compared adjuvants: 71VG, 71VG with VP3, and Alum with VP3. Serum samples were tested for antibodies against homologous vaccine antigens and cross-clade antigens by hemagglutination inhibition (HI) assays. Finally, we evaluated the protective efficacy by lethally challenging immunized chickens with H5 viruses from clade 1 or 2.3.4.4c.
Results
Poultry adjuvant 71VG significantly enhanced antibody responses in chickens with inactivated RG6 compared to unadjuvanted inactivated virus. While increasing antigen dosage enhanced 71VG adjuvanted RG6-induced antibody titers, the vaccine displayed minimal cross-reactivity against locally circulating HPAI H5N2. In contrast, H5N2-VLP containing the HA protein of clade 2.3.4.4c, adjuvanted with (FMDV) VP3 in 71VG, significantly promoted HI antibody responses. All H5N2-VLP immunized chickens survived lethal challenges with the local clade 2.3.4.4c H5 strain.
Conclusion
The study demonstrated the immunogenic potential of the VLP vaccine in chickens. Our findings offer insights for optimizing VLP vaccines, allowing the incorporation of the HA of currently circulating H5 viruses to effectively mitigate the impact of the rapidly evolving clade 2.3.4.4 H5 outbreaks.
{"title":"Vaccine optimization for highly pathogenic avian influenza: Assessment of antibody responses and protection for virus-like particle vaccines in chickens","authors":"Chia-Chi Ku , Cheng-Yu Lin , Chin-Rur Yang , Yu-Chih Yang , Po-Ling Chen , Yi-Te Lin , Pei-Ru Wang , Min-Shi Lee , Shu-Mei Liang , Pei-Wen Hsiao","doi":"10.1016/j.jvacx.2024.100552","DOIUrl":"10.1016/j.jvacx.2024.100552","url":null,"abstract":"<div><h3>Background</h3><p>Recent outbreaks of clade 2.3.4.4b highly pathogenic avian influenza (HPAI) H5N1 viruses in regions previously less affected since 2020 have raised global concerns. Implementing mass immunization or ring vaccination in poultry should be a countermeasure ready to contain disease outbreaks. This study focuses on developing a recombinant H5N2 vaccine based on virus-like particles (VLPs) against clade 2.3.4.4c, the predominant HPAI subclade in Taiwan since its emergence, leading to a large outbreak in 2015.</p></div><div><h3>Methods</h3><p>The study aimed to confirm the effectiveness of clade 2.3.4.4c H5N2 VLPs in protecting chickens and identify the best adjuvants for the VLP vaccine. We used Montanide 71VG-adjuvanted inactivated RG6 to establish the immunization protocol, followed by prime-boost H5N2-VLP immunizations. We compared adjuvants: 71VG, 71VG with VP3, and Alum with VP3. Serum samples were tested for antibodies against homologous vaccine antigens and cross-clade antigens by hemagglutination inhibition (HI) assays. Finally, we evaluated the protective efficacy by lethally challenging immunized chickens with H5 viruses from clade 1 or 2.3.4.4c.</p></div><div><h3>Results</h3><p>Poultry adjuvant 71VG significantly enhanced antibody responses in chickens with inactivated RG6 compared to unadjuvanted inactivated virus. While increasing antigen dosage enhanced 71VG adjuvanted RG6-induced antibody titers, the vaccine displayed minimal cross-reactivity against locally circulating HPAI H5N2. In contrast, H5N2-VLP containing the HA protein of clade 2.3.4.4c, adjuvanted with (FMDV) VP3 in 71VG, significantly promoted HI antibody responses. All H5N2-VLP immunized chickens survived lethal challenges with the local clade 2.3.4.4c H5 strain.</p></div><div><h3>Conclusion</h3><p>The study demonstrated the immunogenic potential of the VLP vaccine in chickens. Our findings offer insights for optimizing VLP vaccines, allowing the incorporation of the HA of currently circulating H5 viruses to effectively mitigate the impact of the rapidly evolving clade 2.3.4.4 H5 outbreaks.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100552"},"PeriodicalIF":2.7,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001256/pdfft?md5=862567a96a8d3dc9674175a63e9a691c&pid=1-s2.0-S2590136224001256-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142167200","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 : 2024-09-01DOI: 10.1016/j.jvacx.2024.100551
Tian Tian , Leiwen Fu , Bingyi Wang , Xinyi Zhou , Yi-Fan Lin , Yanxiao Gao , Yuwei Li , Yinghui Sun , Jianghong Dai , Huachun Zou
Background
Clearance of human papillomavirus (HPV) among adolescent men who have sex with men (MSM) is not well studied. This study aimed to evaluate the clearance of HPV DNA and antibodies among adolescent MSM.
Methods
In our cohort study, we enrolled adolescent MSM in Melbourne between October 2010 and September 2013. At baseline, 3, 6, and 12 months, anal and penile swabs for HPV DNA and serum for HPV antibodies against genotypes 6, 11, 16, and 18, were collected. Definite clearance was defined as HPV DNA (same site) /antibodies for the same genotype undetected following a positive HPV DNA /antibodies test at baseline or month 3. Possible clearance was defined as HPV DNA (same site) /antibodies for the same genotype undetected at month 12 following a positive HPV DNA/antibodies test at month 6. Overall clearance was defined as either definite or possible clearance. The agreement between HPV DNA clearance and antibodies clearance was calculated.
Results
A total of 183 MSM were included (median age: 19 years, interquartile [IQR]: 18 to 20). At the anus, overall clearance rate was 21.6 (95 % confidence interval[CI]: 7.9 to 47.0), 44.8 (19.3 to 88.3), 51.9 (20.9 to 106.9) and 33.7 (7.0 to 98.5) per 1000 person months (PM) for HPV 6, 11, 16 and 18. At the penis, overall clearance rate was 64.5 (13.3 to 188.5), 71.3 (14.7 to 208.2), 96.5 (31.3 to 225.3) and 333.3 (8.4 to 1857.2) per 1000 PM for HPV 6, 11, 16 and 18. For antibodies, overall clearance rate was 22.2 (9.6 to 43.7), 18.8 (3.9 to 55.0), 10.8 (0.3 to 60.1) and 19.0 (2.3 to 68.8) per 1000 PM. Agreement between anal/penile HPV DNA clearance and antibodies clearance was low: kappa = -0.18 (95 % CI: −0.28 to 0.08)/-0.13 (−0.24 to −0.02), 0.04 (−0.29 to 0.36)/0.22 (−0.32 to 0.76), −0.10 (−0.27 to 0.08)/-0.14 (−0.37 to 0.10) and −0.14 (−0.28 to 0.01)/-0.14 (−0.33 to 0.06) for HPV 6, 11, 16 and 18, respectively.
Conclusion
Clearance rates of HPV DNA were low and varied by genotypes and anatomical sites among adolescent MSM. Antibodies against HPV were stable during the study period.
{"title":"Clearance of anal and penile HPV 6, 11, 16, and 18 DNA and antibodies among adolescent men who have sex with men (HYPER): An observational cohort study","authors":"Tian Tian , Leiwen Fu , Bingyi Wang , Xinyi Zhou , Yi-Fan Lin , Yanxiao Gao , Yuwei Li , Yinghui Sun , Jianghong Dai , Huachun Zou","doi":"10.1016/j.jvacx.2024.100551","DOIUrl":"10.1016/j.jvacx.2024.100551","url":null,"abstract":"<div><h3>Background</h3><p>Clearance of human papillomavirus (HPV) among adolescent men who have sex with men (MSM) is not well studied. This study aimed to evaluate the clearance of HPV DNA and antibodies among adolescent MSM.</p></div><div><h3>Methods</h3><p>In our cohort study, we enrolled adolescent MSM in Melbourne between October 2010 and September 2013. At baseline, 3, 6, and 12 months, anal and penile swabs for HPV DNA and serum for HPV antibodies against genotypes 6, 11, 16, and 18, were collected. Definite clearance was defined as HPV DNA (same site) /antibodies for the same genotype undetected following a positive HPV DNA /antibodies test at baseline or month 3. Possible clearance was defined as HPV DNA (same site) /antibodies for the same genotype undetected at month 12 following a positive HPV DNA/antibodies test at month 6. Overall clearance was defined as either definite or possible clearance. The agreement between HPV DNA clearance and antibodies clearance was calculated.</p></div><div><h3>Results</h3><p>A total of 183 MSM were included (median age: 19 years, interquartile [IQR]: 18 to 20). At the anus, overall clearance rate was 21.6 (95 % confidence interval[CI]: 7.9 to 47.0), 44.8 (19.3 to 88.3), 51.9 (20.9 to 106.9) and 33.7 (7.0 to 98.5) per 1000 person months (PM) for HPV 6, 11, 16 and 18. At the penis, overall clearance rate was 64.5 (13.3 to 188.5), 71.3 (14.7 to 208.2), 96.5 (31.3 to 225.3) and 333.3 (8.4 to 1857.2) per 1000 PM for HPV 6, 11, 16 and 18. For antibodies, overall clearance rate was 22.2 (9.6 to 43.7), 18.8 (3.9 to 55.0), 10.8 (0.3 to 60.1) and 19.0 (2.3 to 68.8) per 1000 PM. Agreement between anal/penile HPV DNA clearance and antibodies clearance was low: <em>kappa</em> = -0.18 (95 % CI: −0.28 to 0.08)/-0.13 (−0.24 to −0.02), 0.04 (−0.29 to 0.36)/0.22 (−0.32 to 0.76), −0.10 (−0.27 to 0.08)/-0.14 (−0.37 to 0.10) and −0.14 (−0.28 to 0.01)/-0.14 (−0.33 to 0.06) for HPV 6, 11, 16 and 18, respectively.</p></div><div><h3>Conclusion</h3><p>Clearance rates of HPV DNA were low and varied by genotypes and anatomical sites among adolescent MSM. Antibodies against HPV were stable during the study period.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100551"},"PeriodicalIF":2.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001244/pdfft?md5=456806e08a34c17c107d9285d1ce16af&pid=1-s2.0-S2590136224001244-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142136524","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 aim of the research is to analyze and improve the performance of the vaccine quality control queuing system to reduce delays and achieve the firm’s long-term goal on vaccine production capacity. The research focuses on the Bacterial Vaccine Quality Control (BVQC) at the largest vaccine manufacturers in Indonesia and Southeast Asia. The vaccines handled by BVQC include TT, DTP, BCG, BioTT, BioTd, DT, Td, and DTP-Hb-Hib. The BVQC operates a queuing system with eight servers, each assigned a fixed task. The existing system experienced delays ranging from 13 % to 61 % from January to June 2022. After identifying the queuing characteristics of the existing system, improvement proposals were suggested by modifying the assignment of the servers. This proposal was then simulated in November 2022, resulting in improved performance with no delays, a reduction in the length of the queue in the system (Lq) from 2.88 to 2.59, and a reduction in the average time spent in the system (Ws) from 0.0099 to 0.0044. The research suggests that modifying server assignments can be an effective method for improving the performance of a queuing system in vaccine quality control. This can lead to reduced delays, optimized queue lengths, and improved overall efficiency, potentially enhancing the firm’s ability to meet vaccine demand in the future.
{"title":"Queuing analysis for improving performance in bacterial vaccine quality control process","authors":"Sallyta Ayu Martha , Akhmad Yunani , Wega Setiabudi , Budi Harsanto","doi":"10.1016/j.jvacx.2024.100550","DOIUrl":"10.1016/j.jvacx.2024.100550","url":null,"abstract":"<div><p>The aim of the research is to analyze and improve the performance of the vaccine quality control queuing system to reduce delays and achieve the firm’s long-term goal on vaccine production capacity. The research focuses on the Bacterial Vaccine Quality Control (BVQC) at the largest vaccine manufacturers in Indonesia and Southeast Asia. The vaccines handled by BVQC include TT, DTP, BCG, BioTT, BioTd, DT, Td, and DTP-Hb-Hib. The BVQC operates a queuing system with eight servers, each assigned a fixed task. The existing system experienced delays ranging from 13 % to 61 % from January to June 2022. After identifying the queuing characteristics of the existing system, improvement proposals were suggested by modifying the assignment of the servers. This proposal was then simulated in November 2022, resulting in improved performance with no delays, a reduction in the length of the queue in the system (Lq) from 2.88 to 2.59, and a reduction in the average time spent in the system (Ws) from 0.0099 to 0.0044. The research suggests that modifying server assignments can be an effective method for improving the performance of a queuing system in vaccine quality control. This can lead to reduced delays, optimized queue lengths, and improved overall efficiency, potentially enhancing the firm’s ability to meet vaccine demand in the future.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100550"},"PeriodicalIF":2.7,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001232/pdfft?md5=f4a6faefedab08ee4b05b5ca3a76da11&pid=1-s2.0-S2590136224001232-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142047898","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}
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