Vaccine: XPub Date : 2025-05-26DOI: 10.1016/j.jvacx.2025.100665
Yajing Zhang , Benjie Chai , Fei Huang , Biao Niu , Yangyang Liu , Pengpeng Zhou , Hui Wang , Yue Guo , Zhenfang Fu , Qi An , Dayong Tian
{"title":"Optimization and application of a mouse challenge model for Mumps virus","authors":"Yajing Zhang , Benjie Chai , Fei Huang , Biao Niu , Yangyang Liu , Pengpeng Zhou , Hui Wang , Yue Guo , Zhenfang Fu , Qi An , Dayong Tian","doi":"10.1016/j.jvacx.2025.100665","DOIUrl":"10.1016/j.jvacx.2025.100665","url":null,"abstract":"<div><div>Mumps is an acute respiratory infectious disease that occasionally experiences outbreaks even in countries with high vaccination rates. This indicates potential antigenic differences between currently available vaccine strains and circulating wild-type viruses. Therefore, it is crucial to evaluate the vaccine's protective efficacy against the epidemic strain. In this study, we injected IFN-α/βR<sup>−/−</sup> mice with genotype F or G wild-type strains via the tail vein. The mumps virus rapidly replicated and maintained high levels in the blood. Furthermore, prior immunization of IFN-α/βR<sup>−/−</sup> mice with vaccine strain significantly inhibited viral replication in vivo. Consequently, we have optimized a valuable model for assessing the effectiveness of MuV vaccines.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100665"},"PeriodicalIF":2.7,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144178224","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}
{"title":"A multi-centre, single arm, Phase 3 study to assess the safety and reactogenicity of biological Es Vi-capsular polysaccharide-CRM197 conjugate typhoid vaccine in ≥6 months old infants to ≤45 years old adults.","authors":"Subhash Thuluva , Ramesh V. Matur , Subbareddy Gunneri , Vijay Yerroju , Rammohan Reddy Mogulla , Chirag Dhar , Raju Esanakarra , Savita Verma , Manish Narang , Madhukar Pandey","doi":"10.1016/j.jvacx.2025.100669","DOIUrl":"10.1016/j.jvacx.2025.100669","url":null,"abstract":"<div><h3>Background</h3><div>Typhoid fever is a serious bacterial infection caused by <em>Salmonella Typhi</em>, with a significant burden in low- and middle-income countries, particularly in Sub-Saharan Africa and South/Southeast Asia. To mitigate its spread, the World Health Organization (WHO) advocates for typhoid vaccination programs that particularly target high-risk populations. However, unconjugated polysaccharide vaccines have shown limited efficacy in children under two years of age.</div><div>Biological E has developed a typhoid conjugate vaccine, TYPHIBEV®, which incorporates the Vi-polysaccharide conjugated to the CRM<sub>197</sub> carrier protein. TYPHIBEV®’s safety and immunogenicity were evaluated in Phase 1 and Phase 2/3 clinical trials involving infants, children, adolescents, and adults, compared to an established licensed vaccine. This Phase 3 study was specifically designed to assess the safety profile of TYPHIBEV® in the target population aged ≥6 months to ≤45 years.</div></div><div><h3>Methods</h3><div>A multi-centre, single-arm, non-comparative Phase 3 study was conducted to evaluate the safety, tolerability and reactogenicity of a single intramuscular dose of Biological E's Vi-capsular Polysaccharide-CRM<sub>197</sub> Conjugate Typhoid Vaccine. A total of 1770 subjects were enrolled into three age subsets; infants and toddlers, ≥6 months to <2 years of age; children and adolescents, ≥2 years to <18 years of age; and adults, ≥18 years to ≤45 years of age (<em>n</em> = 590 in each age group). A single dose of THPHIBEV® was administered, and all the subjects were followed up for a period of 42 days. Solicited local and systemic AEs were recorded up until 7 days post-vaccination. Unsolicited AEs, serious AEs (SAEs), and medically attended AEs (MAAEs) were recorded throughout the study duration.</div></div><div><h3>Findings</h3><div>A total of 114 AEs were recorded in 101 (5.71 %) participants. A majority of these AEs were solicited in nature with general disorders and administration site conditions reported in 5.42 % of participants. The most commonly reported AEs were injection site pain and pyrexia. All MAAEs (1.30 % subjects) were solicited and pyrexia (0.85 % of subjects) was the most common reason for medical attention. No severe or serious AEs and/or deaths were reported throughout the study. None of the subjects discontinued the study due to an AE.</div></div><div><h3>Conclusions</h3><div>TYPHIBEV® was found to be safe and well tolerated across different age groups and the safety profile was comparable to other TCVs in terms of reported solicited and unsolicited AEs. No severe or serious AEs were reported during the entire study period.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100669"},"PeriodicalIF":2.7,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144167292","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}
Vaccine: XPub Date : 2025-05-22DOI: 10.1016/j.jvacx.2025.100667
Idbarka Abdellatif , Kadim Oumaima , Soulhi Imane , Piro Mohammed , Amrani Nadia , Azrib Rahma , Kadiri Ahlam , Daden Reda , El Allali Khalid
{"title":"Serological evaluation of the immune protection conferred by the canine parvovirus vaccine: A comparative study of a recommended brief protocol and WSAVA protocols","authors":"Idbarka Abdellatif , Kadim Oumaima , Soulhi Imane , Piro Mohammed , Amrani Nadia , Azrib Rahma , Kadiri Ahlam , Daden Reda , El Allali Khalid","doi":"10.1016/j.jvacx.2025.100667","DOIUrl":"10.1016/j.jvacx.2025.100667","url":null,"abstract":"<div><div>Canine parvovirus (CPV) is a highly contagious and often fatal viral disease in puppies, with high morbidity and mortality rates. Despite vaccination, failures have been reported, especially with the short protocol (BP) recommended by some pharmaceutical companies, which may not align with the World Small Animal Veterinary Association (WSAVA) 2024 guidelines.</div><div>This study aimed to evaluate the effectiveness of immunity in puppies vaccinated with the BP protocol and assess whether boosters based on the WSAVA guidelines would improve immunity. Experiment 1 involved unvaccinated puppies receiving the WSAVA vaccination protocol, with four vaccinations at 15-day intervals. Experiment 2 assessed puppies vaccinated with the BP protocol, followed by two additional booster doses administered two weeks apart.</div><div>In Experiment 1, puppies receiving the WSAVA protocol had insufficient maternal antibodies (32.00 ± 14.99) at 12–16 weeks. After four vaccinations, antibody titers significantly increased to 256.00 ± 79.43 by day 45 (<em>p = 0.0166</em>). In Experiment 2, puppies vaccinated with the BP protocol showed antibody titers of 32.00 ± 32.57 at 5 months, below the protective threshold. Two additional boosters raised antibody titers to 512.00 ± 245.0 at day 45 (<em>p = 0.0154</em>). These results indicate that the BP protocol alone does not provide adequate immunity but that Additional boosters can improve immunity. The WSAVA vaccination protocol effectively protects against CPV, while the BP protocol requires additional boosters to meet protective standards. Implementing WSAVA-guideline-based boosters is essential to improve CPV protection in puppies.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100667"},"PeriodicalIF":2.7,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144167411","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}
Vaccine: XPub Date : 2025-05-21DOI: 10.1016/j.jvacx.2025.100658
Shannon Haughney , Seth Clark , Elizabeth Carey , Nelson Lee Afanador , Victoria Stabile , Bernard Kang , Samantha Marrone , Jillian Shingler , Carl Hofmann , Christopher J. Wang , Christopher Ton
{"title":"Optimization for the production of a dengue live-attenuated Quadrivalent vaccine in Vero cells grown on microcarriers","authors":"Shannon Haughney , Seth Clark , Elizabeth Carey , Nelson Lee Afanador , Victoria Stabile , Bernard Kang , Samantha Marrone , Jillian Shingler , Carl Hofmann , Christopher J. Wang , Christopher Ton","doi":"10.1016/j.jvacx.2025.100658","DOIUrl":"10.1016/j.jvacx.2025.100658","url":null,"abstract":"<div><div>Dengue is a mosquito-borne disease and is a major global health threat, especially in tropical and subtropical regions. In this study, we describe the optimization of virus production for a dengue live-attenuated quadrivalent vaccine candidate and demonstrate scalability of a stirred tank bioreactor serum-free microcarrier process. We utilized a design-of-experiment (DoE) methodology to optimize for pH and temperature and evaluate effect of Multiplicity of Infection (MOI) and Time of Infection (TOI) for each serotype during virus production in 2 L and 3 L bioreactors. The optimal pH and temperature for dengue virus production achieved ∼10× higher virus titer at peak virus production for all 4 serotypes compared to baseline condition. Different MOI and TOI did not impact peak virus production. Results from the DoE studies were successfully scaled to the 50 L Single-Use Bioreactor (SUB).</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100658"},"PeriodicalIF":2.7,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144105415","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}
Vaccine: XPub Date : 2025-05-21DOI: 10.1016/j.jvacx.2025.100654
Muhammad Zain Ul Haq , Hamza Irfan , Muhammad Shahmeer Ullah Shah , Anusha Sumbal , Sanila Mughal , Saad Ashraf , Areeba Aamir Ali Basaria , Abdullah , Muhammad Aaqib Chacho , Biruk Demisse Ayalew
{"title":"Immunogenicity, safety and tolerability of 15-valent pneumococcal conjugate vaccine (V114) compared to 13-valent pneumococcal conjugate vaccine (PCV-13) in healthy infants: A systematic review and meta-analysis","authors":"Muhammad Zain Ul Haq , Hamza Irfan , Muhammad Shahmeer Ullah Shah , Anusha Sumbal , Sanila Mughal , Saad Ashraf , Areeba Aamir Ali Basaria , Abdullah , Muhammad Aaqib Chacho , Biruk Demisse Ayalew","doi":"10.1016/j.jvacx.2025.100654","DOIUrl":"10.1016/j.jvacx.2025.100654","url":null,"abstract":"<div><h3>Introduction</h3><div><em>Streptococcus pneumoniae</em> is a major cause of infectious diseases, particularly in children under 5, leading to approximately 300,000 deaths annually. The introduction of pneumococcal conjugate vaccines (PCVs), such as PCV13, has significantly reduced invasive pneumococcal disease (IPD). However, rising cases of IPD caused by non-vaccine serotypes highlight the need for broader coverage vaccines like PCV15 (V114). This study aims to evaluate the immunogenicity and safety of V114 compared to PCV13 in healthy infants.</div></div><div><h3>Methods</h3><div>This systematic review and meta-analysis followed PRISMA guidelines and was registered with PROSPERO (CRD42024576730). Two reviewers searched MEDLINE, Google Scholar, and Cochrane databases for randomized controlled trials (RCTs) comparing V114 and PCV13 in infants. Data were extracted on immunogenicity (IgG response and geometric mean concentration) and safety outcomes. Meta-regression was conducted using R software for variables where heterogeneity could not be explained through subgroup analysis or leave-one-out analysis.</div></div><div><h3>Results</h3><div>A total of 11 RCTs involving 9970 infants were included. Immunogenicity results indicated higher seropositivity for shared serotypes in PCV13, while V114 showed superior responses for unique serotypes (22F and 33F). No significant differences in overall adverse effects were observed between the two vaccines, although injection-site pain was more common with V114 and urticaria was noted more frequently with PCV13.</div></div><div><h3>Conclusion</h3><div>V114 demonstrated enhanced immunogenicity for certain serotypes and comparable safety profiles to PCV13. The findings support the potential of V114 to address the limitations of current vaccines, particularly against non-vaccine serotypes. Further research is necessary to evaluate long-term immunity and real-world effectiveness.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100654"},"PeriodicalIF":2.7,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144124713","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}
Vaccine: XPub Date : 2025-05-21DOI: 10.1016/j.jvacx.2025.100660
Alison E. Simmons , Rafael N. Miranda , Michael W.Z. Li , Gebremedhin B. Gebretekle , Min Xi , Marina I. Salvadori , Bryna Warshawsky , Eva Wong , Raphael Ximenes , Melissa K. Andrew , Sarah Wilson , Matthew Tunis , Ashleigh R. Tuite
{"title":"Cost-utility analysis of current COVID-19 vaccination program recommendations in Canada","authors":"Alison E. Simmons , Rafael N. Miranda , Michael W.Z. Li , Gebremedhin B. Gebretekle , Min Xi , Marina I. Salvadori , Bryna Warshawsky , Eva Wong , Raphael Ximenes , Melissa K. Andrew , Sarah Wilson , Matthew Tunis , Ashleigh R. Tuite","doi":"10.1016/j.jvacx.2025.100660","DOIUrl":"10.1016/j.jvacx.2025.100660","url":null,"abstract":"<div><h3>Background</h3><div>As COVID-19 becomes established as an endemic disease with widespread population immunity, there is uncertainty about the economic benefit of ongoing COVID-19 vaccination programs. We assessed the cost-effectiveness of a COVID-19 vaccination program similar to current Canadian recommendations, modelled as annual vaccination for people aged less than 65 years with chronic medical conditions and biannual vaccination for adults aged 65 years and older.</div></div><div><h3>Methods</h3><div>Using a static individual-based model of medically attended COVID-19 in a population of one million people, we estimated costs (in 2023 Canadian dollars), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). We used health system and societal perspectives and a 1.5 % discount rate. Parameters were based on recent COVID-19 epidemiology, vaccine characteristics, and costs.</div></div><div><h3>Results</h3><div>Between July 2024 and September 2025, a program similar to current Canadian recommendations was estimated to avert 3.1 % (95 % credible interval (CrI): 3.0 to 3.2 %) of outpatient cases, 8.8 % (95 % CrI: 7.3 to 10.4 %) of inpatient cases, 3.6 % (95 % CrI: 2.8 to 4.3 %) of PCC cases, and 9.4 % (95 % CrI: 5.6 to 13.8 %) of deaths compared to no vaccination. The number needed to vaccinate to prevent one hospitalization and one death was 1121 (95 % CrI: 941 to 1357) and 8656 (95 % CrI: 5848 to 14,915), respectively. For the health system perspective, the program would cost an additional $4.695 million but result in 221.17 QALYs gained, leading to an ICER of $21,227 per QALY compared to no vaccination. Vaccine price influenced cost-effectiveness, with higher prices reducing the likelihood the program met common cost-effectiveness thresholds.</div></div><div><h3>Conclusions</h3><div>A program similar to current COVID-19 recommendations in Canada is likely effective and cost-effective compared to no vaccination. However, unlike some other research studies, alternate vaccination strategies that may offer better value for money were not evaluated.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100660"},"PeriodicalIF":2.7,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144124686","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}
Vaccine: XPub Date : 2025-05-21DOI: 10.1016/j.jvacx.2025.100659
Alexa Dierig , Martina Kristof , Christina Dold , Elodie Lesne , Catpagavalli Asokanathan , Luke Blackwell , Barbara Bolgiano , Andrew R. Gorringe , Andrew J. Pollard , Kevin Markey , Christine S. Rollier
{"title":"Adenoviral-vectored vaccine against Bordetella pertussis fimbrial antigen induces partial protection in a mouse model","authors":"Alexa Dierig , Martina Kristof , Christina Dold , Elodie Lesne , Catpagavalli Asokanathan , Luke Blackwell , Barbara Bolgiano , Andrew R. Gorringe , Andrew J. Pollard , Kevin Markey , Christine S. Rollier","doi":"10.1016/j.jvacx.2025.100659","DOIUrl":"10.1016/j.jvacx.2025.100659","url":null,"abstract":"<div><div>Pertussis has been resurgent in many countries worldwide despite good vaccine coverage. One hypothesis for this resurgence is that the current acellular pertussis (aP) vaccines, used in most developed countries, induce short-term protection, and do not prevent asymptomatic infection and transmission of pertussis infection. As a first step to address these issues we developed novel <em>Bordetella pertussis</em> vaccine candidates using viral-vectored vaccine technology with the aim of producing durable functional antibodies that prevent nasal colonization. Fimbrial antigens Fim2 and Fim3 are protective in mouse models of <em>B. pertussis</em> disease and are included in some aP vaccines. Fim2, Fim3 and FimD were selected, and their genes cloned into entry plasmids for the creation of the corresponding human adenovirus serotype 5 (AdHu5) vectors. Groups of mice were vaccinated with a single dose of either of the three AdHu5 vaccines, or a mixture of them, or control vaccines, which consisted of one or two reduced doses of a whole-cell pertussis vaccine or 5-component aP vaccine. The Fim2 and Fim3 adenovirus-based vaccines and their combinations alone or with FimD induced antigen-specific antibodies, as assessed by whole cell ELISA assay. Strong IgG binding to a Fim3-expressing strain was observed using flow cytometry and these antibodies also mediated complement deposition onto this strain. The AdHu5 Fim3 vaccine induced partial protection against lung infection following aerosol exposure of mice to <em>B. pertussis</em> expressing Fim3. These results indicate that adenovirus vectors have the potential to be effective vaccine platforms for bacterial disease.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100659"},"PeriodicalIF":2.7,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144131437","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}
Vaccine: XPub Date : 2025-05-20DOI: 10.1016/j.jvacx.2025.100661
Bernie Endyarni Medise , I. Gusti Ayu Trisna Windiani , Dominicus Husada , Rini Sekartini , Hartono Gunardi , Angga Wirahmadi , Dwiyanti Puspitasari , Leny Kartina , I. Gusti Agung Ngurah Sugitha Adnyana , I. Gusti Lanang Sidiartha , I. Made Dwi Lingga Utama , I. Ketut Agus Somia , Iris Rengganis , Sukamto Koesnoe , Hindra Irawan Satari , Soedjatmiko Soedjatmiko , Sri Rezeki Hadinegoro , Ismoedijanto Ismoedijanto , Parwati Setiono Basuki , Gatot Soegiarto , Sushant Sahastrabuddhe
{"title":"One-month evaluation of safety and immunogenicity of a Vi-DT typhoid conjugate vaccine (Bio-TCV®) in Indonesian subjects 6 months to 45 years: A phase III randomized clinical trial","authors":"Bernie Endyarni Medise , I. Gusti Ayu Trisna Windiani , Dominicus Husada , Rini Sekartini , Hartono Gunardi , Angga Wirahmadi , Dwiyanti Puspitasari , Leny Kartina , I. Gusti Agung Ngurah Sugitha Adnyana , I. Gusti Lanang Sidiartha , I. Made Dwi Lingga Utama , I. Ketut Agus Somia , Iris Rengganis , Sukamto Koesnoe , Hindra Irawan Satari , Soedjatmiko Soedjatmiko , Sri Rezeki Hadinegoro , Ismoedijanto Ismoedijanto , Parwati Setiono Basuki , Gatot Soegiarto , Sushant Sahastrabuddhe","doi":"10.1016/j.jvacx.2025.100661","DOIUrl":"10.1016/j.jvacx.2025.100661","url":null,"abstract":"<div><h3>Background</h3><div>Typhoid fever typically affects children and young adults and is a considerable cause of morbidity and mortality. Vaccination is the most effective preventive strategy to control typhoid fever in the short to medium term. However, in most endemic countries do not have a typhoid vaccine that is suitable for children below 2 years old.</div></div><div><h3>Methods</h3><div>This is a randomized, observer blinded phase III trial using Vi-DT typhoid conjugate vaccine and an already WHO licensed prequalified (PQed) typhoid conjugate vaccine (Typbar TCV) as control. About 936 healthy subjects were recruited and divided into 3 age groups: infants group aged 6–24 months, children group aged 2–11 years, adolescents and adults group aged 12–45 years, and followed up till 28 days post vaccination. Blood sample was taken at pre-vaccination and at 28th day post vaccination to evaluate immunogenicity.</div></div><div><h3>Results</h3><div>The most common immediate local reaction was pain in all age groups, followed by redness. The most common immediate systemic reaction in the infant group was irritability while in the adults and children group was muscle pain. The intensity of reactions was mostly mild and moderate. Severe reactions were in the form of pain and fever. Reactions mostly resolved within 48 h. Seroconversion at 28 days in the Vi-DT group was higher in both adults and children compared to the PQed typhoid conjugate vaccine, Typbar-TCV (<em>p</em> = 1.000; <em>p</em> = 0.250), respectively. The Geometric Mean Titer (GMT) in the Vi-DT group was higher in adults (<em>p</em> = 0134), whereas the PQed typhoid conjugate vaccine Typbar-TCV demonstrated a higher GMT in children and infants (<em>p</em> = 0.277; <em>p</em> = 0.884), respectively.</div></div><div><h3>Conclusion</h3><div>Vi-DT typhoid conjugate vaccine (Bio-TCV®) is safe and immunogenic in subjects 6 months to 45 years old.</div><div>Clinical trial registration number.</div><div><span><span>NCT04051268</span><svg><path></path></svg></span>, registration date: 09/08/2019.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100661"},"PeriodicalIF":2.7,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144167410","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}
Vaccine: XPub Date : 2025-05-20DOI: 10.1016/j.jvacx.2025.100662
Wendy Boivin , Mark Loeb , Peter Openshaw , Mansoor Ashraf , Graham Pawelec
{"title":"Seasonal influenza vaccination: Overcoming immunosenescence with enhanced vaccines","authors":"Wendy Boivin , Mark Loeb , Peter Openshaw , Mansoor Ashraf , Graham Pawelec","doi":"10.1016/j.jvacx.2025.100662","DOIUrl":"10.1016/j.jvacx.2025.100662","url":null,"abstract":"<div><div>Influenza causes substantial morbidity and mortality worldwide. Risks are increased in older adults aged 50–64 and ≥ 65 years. They are further exacerbated in those with age-related comorbidities. Immunosenescence (strictly defined here as detrimental age-related decline in the function of some or all parts of the immune system) is associated with increased susceptibility to influenza infection and more severe disease, a process that begins at approximately 50 years of age. Age-associated chronic low-level inflammation (inflammaging) may also increase influenza risk and is associated with more serious disease but may also enhance responses to high-dose vaccines in older adults. The frequency of comorbidities also increases with age. Frail older adults are at highest risk of influenza complications, but adults with high-risk comorbidities also show improved immune responses to enhanced influenza vaccines (high-dose, adjuvanted, recombinant). Moreover, clinical studies with some enhanced influenza vaccines show improved immunogenicity and greater efficacy or effectiveness, not only for persons aged ≥65 years but also in those aged 50–64 years. Reduced immunogenicity in persons aged 50–64 years may be even greater in those with comorbidities who would specifically benefit from receiving enhanced vaccines. Thus, accelerated immunosenescence, inflammaging, and chronic disease may place some adults aged 50–64 years at high risk of influenza, justifying meeting an unmet need in vaccination with enhanced vaccines normally used in persons ≥65 years of age.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100662"},"PeriodicalIF":2.7,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144105414","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}
Vaccine: XPub Date : 2025-05-20DOI: 10.1016/j.jvacx.2025.100657
Arman Majidulla , Amelia K. Gerste , Anurima Baidya , Onimitein Georgewill , Kirthini K. Muralidharan , Degu J. Dare , Joeri S. Buis , Michelle M. Gill , Julie A. Denison , Andrew D. Kerkhoff , Rupali J. Limaye
{"title":"Adolescent vaccine introductions scoping review: A decade of insights from low- and middle-income countries (2013−2023)","authors":"Arman Majidulla , Amelia K. Gerste , Anurima Baidya , Onimitein Georgewill , Kirthini K. Muralidharan , Degu J. Dare , Joeri S. Buis , Michelle M. Gill , Julie A. Denison , Andrew D. Kerkhoff , Rupali J. Limaye","doi":"10.1016/j.jvacx.2025.100657","DOIUrl":"10.1016/j.jvacx.2025.100657","url":null,"abstract":"<div><h3>Background</h3><div>Adolescents benefit from vaccines before infection – such as HPV – but parental consent and frequent social interactions complicate their introductions. We conducted a scoping review of the literature (2013 to 2023) on adolescent vaccine introduction efforts in low- and middle-income countries to examine lessons learned.</div></div><div><h3>Method</h3><div>Following the PRISMA guideline, we searched four databases, screened abstracts and reviewed full text articles for inclusion. We included English full text articles which provided insights based on primary data collection into vaccine introductions for adolescents over the past ten years (i.e., 2013 onwards). We further searched the citations of included articles. We coded included articles for key characteristics and analyzed for thematic commonalities.</div></div><div><h3>Results</h3><div>Twenty-six studies met our inclusion criteria, and the findings clustered across three distinct phases of new vaccine introduction: planning, implementation/delivery, and post-implementation/delivery. During the planning phase, the early engagement of stakeholders – particularly ministries of health and education - was critical for coordination and readiness. During implementation, school-based delivery was the most common approach, often supplemented by community outreach and mop-up activities to reach out-of-school adolescents. Opt-out consent was used as a strategy in some contexts in keeping with existing adolescent vaccine protocols. Vaccine rumors and conspiracy needed to be actively managed in some contexts. Post-introduction, health systems impacts were generally minimal and temporary, although human resource constraints and cold-chain gaps emerged in some settings. Several countries reported positive spillover effects, such as strengthened collaboration between health and education sectors, expanded adolescent health promotion, and investments in vaccine infrastructure.</div></div><div><h3>Conclusion</h3><div>Adolescent vaccine introductions required multisectoral collaboration, flexible delivery models, and proactive community engagement. Future vaccine introductions would benefit from early stakeholder coordination and attention to context-specific delivery and consent strategies to ensure that vaccines are accepted, accessible, and equitably delivered.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100657"},"PeriodicalIF":2.7,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144178226","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}