Haemophilus influenzae type a (Hia) disease is associated with fatality and morbidity, predominantly in children from Northern indigenous communities in Canada and Alaska. Symptoms include but are not limited to meningitis, sepsis, pneumonia, otitis media and bacteremia. A key virulence factor associated with Hia pathogenesis is the bacterial capsular polysaccharides. Prophylactic vaccines targeting the capsular polysaccharide (CPS) antigens is considered a promising intervention strategy given the effectiveness of polysaccharide-protein conjugate vaccines against diverse bacterial pathogens. In the same vein, we in this study have presented the development of Hia conjugate vaccine involving hydrazide-polyethylene glycol-hydrazide linker with rCRM197 as a carrier protein. Preclinical immunogenicity data indicated induction of robust serum bactericidal antibody responses at a 10-μg CPS antigen dose in rabbits like the PedvaxHIB® comparator, leading to evaluation of the Hia vaccine candidate in Phase I clinical trials.
{"title":"Preclinical immunogenicity studies of Haemophilus influenzae type a glycoconjugate vaccine","authors":"Gowri Chellappan , Florence Seal , Winston Umakanth Balasundaram , Yutai Zhao , Giriraj Chalke , Shangdong Guo , Gowthami Jagruthi Penumaka , Geetha Karengil , Amandeep Grewal , Rashmi Ghayal , Jen Gan , Richa Puri , Dimple Reshma Machado , Aakriti Bajracharya , Pradip Ghate , Anup Datta , Subhash V. Kapre","doi":"10.1016/j.vaccine.2026.128242","DOIUrl":"10.1016/j.vaccine.2026.128242","url":null,"abstract":"<div><div><em>Haemophilus influenzae</em> type a (Hia) disease is associated with fatality and morbidity, predominantly in children from Northern indigenous communities in Canada and Alaska. Symptoms include but are not limited to meningitis, sepsis, pneumonia, otitis media and bacteremia. A key virulence factor associated with Hia pathogenesis is the bacterial capsular polysaccharides. Prophylactic vaccines targeting the capsular polysaccharide (CPS) antigens is considered a promising intervention strategy given the effectiveness of polysaccharide-protein conjugate vaccines against diverse bacterial pathogens. In the same vein, we in this study have presented the development of Hia conjugate vaccine involving hydrazide-polyethylene glycol-hydrazide linker with rCRM197 as a carrier protein. Preclinical immunogenicity data indicated induction of robust serum bactericidal antibody responses at a 10-μg CPS antigen dose in rabbits like the PedvaxHIB® comparator, leading to evaluation of the Hia vaccine candidate in Phase I clinical trials.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128242"},"PeriodicalIF":4.5,"publicationDate":"2026-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146004800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-18DOI: 10.1016/j.vaccine.2026.128226
Ariel B. Handy , Boyu Ren , Laura C. Seidman , Steven W. Granger , Laura A. Payne
Purpose
Changes in menstrual cycle characteristics following COVID-19 vaccination have been reported in women and adolescent girls, yet the biological mechanisms underlying these changes remain poorly understood. Inflammation, though frequently hypothesized as a possible mechanism underlying this finding, has yet to be explicitly studied. Thus, the present study examined the relationships of ovarian hormones and inflammatory processes pre- and post-COVID-19 booster vaccination to menstrual changes among adolescent girls.
Methods
47 adolescent girls aged 13–20 who received a COVID-19 booster vaccination provided saliva samples and completed self-reported measures at five time points across the menstrual cycle. Saliva samples were assayed for inflammatory markers IL-1β, IL-6, TNF-α and ovarian hormones estradiol (E2) and progesterone.
Results
Higher levels of IL-1β, measured 24 h post-vaccination, were significantly associated with shorter cycle length in the cycle during which the booster was administered. No significant effects were found for ovarian hormones or other inflammatory markers. Cluster analyses based on anti-spike immunoglobulin G (IgG) levels identified two distinct immune response profiles (high and low responders), though this was not significantly associated with menstrual cycle changes.
Conclusions
Pro-inflammatory cytokine IL-1β plays a significant role in explaining the shortening of the menstrual cycle following COVID-19 vaccination in adolescent girls, primarily impacting the cycle in which the vaccine was received This finding suggests that vaccine-induced inflammation can influence menstrual cycle regulation in adolescents, possibly due to the immaturity of the HPO-axes during adolescence.
{"title":"Inflammatory mechanisms of menstrual cycle changes following COVID-19 vaccination in adolescents","authors":"Ariel B. Handy , Boyu Ren , Laura C. Seidman , Steven W. Granger , Laura A. Payne","doi":"10.1016/j.vaccine.2026.128226","DOIUrl":"10.1016/j.vaccine.2026.128226","url":null,"abstract":"<div><h3>Purpose</h3><div>Changes in menstrual cycle characteristics following COVID-19 vaccination have been reported in women and adolescent girls, yet the biological mechanisms underlying these changes remain poorly understood. Inflammation, though frequently hypothesized as a possible mechanism underlying this finding, has yet to be explicitly studied. Thus, the present study examined the relationships of ovarian hormones and inflammatory processes pre- and post-COVID-19 booster vaccination to menstrual changes among adolescent girls.</div></div><div><h3>Methods</h3><div>47 adolescent girls aged 13–20 who received a COVID-19 booster vaccination provided saliva samples and completed self-reported measures at five time points across the menstrual cycle. Saliva samples were assayed for inflammatory markers IL-1β, IL-6, TNF-α and ovarian hormones estradiol (E2) and progesterone.</div></div><div><h3>Results</h3><div>Higher levels of IL-1β, measured 24 h post-vaccination, were significantly associated with shorter cycle length in the cycle during which the booster was administered. No significant effects were found for ovarian hormones or other inflammatory markers. Cluster analyses based on anti-spike immunoglobulin G (IgG) levels identified two distinct immune response profiles (high and low responders), though this was not significantly associated with menstrual cycle changes.</div></div><div><h3>Conclusions</h3><div>Pro-inflammatory cytokine IL-1β plays a significant role in explaining the shortening of the menstrual cycle following COVID-19 vaccination in adolescent girls, primarily impacting the cycle in which the vaccine was received This finding suggests that vaccine-induced inflammation can influence menstrual cycle regulation in adolescents, possibly due to the immaturity of the HPO-axes during adolescence.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128226"},"PeriodicalIF":4.5,"publicationDate":"2026-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146004808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-17DOI: 10.1016/j.vaccine.2026.128228
Tafadzwa Dzinamarira , Oscar Mano , Godfrey Musuka , Roda Madziva , Noah Mataruse , Elliot Mbunge , Sphamandla Josias Nkambule , Enos Moyo
Background
Despite global progress in childhood immunization, Sub-Saharan Africa (SSA) continues to report suboptimal coverage and high under-five mortality. This systematic review and meta-analysis assessed the prevalence and determinants of full immunization among children under five in SSA between 2013 and 2025.
Methods
We systematically searched six electronic databases for studies published between January 2013 and May 2025 that reported the prevalence and/or determinants of full immunization in SSA. Eligible studies were original, peer-reviewed quantitative research. Data were analysed using random-effects meta-analysis, with subgroup and sensitivity analyses conducted to explore heterogeneity. Determinants were synthesised using pooled odds ratios (ORs) where applicable.
Results
Thirty-one studies comprising 299,898 children were included. The pooled prevalence of full immunization was 51% (95% CI: 45%–58%), with substantial heterogeneity (I2 = 100%). Prevalence varied widely across studies from 6% to 96%. Subgroup analyses revealed lower coverage in recent years and in studies with larger sample sizes. Key positive determinants of full immunization included maternal education (OR = 2.70), paternal education (OR = 2.48), antenatal care attendance (OR = 0.23 for non-attendance), institutional delivery (OR = 2.99), and household wealth (OR = 2.45). Children in rural areas (OR = 0.55) and those with mothers of higher parity (OR = 0.67) were less likely to be fully immunised.
Conclusion
Full immunization coverage in SSA remains well below global targets, with wide disparities by country, socioeconomic status, and maternal healthcare utilization. Strengthening maternal health services, improving education, and addressing health system barriers are critical to improving coverage and reducing preventable child deaths in the region.
{"title":"Prevalence and determinants of full immunization among children under five in sub-Saharan Africa: A systematic review and meta-analysis (2013–2025)","authors":"Tafadzwa Dzinamarira , Oscar Mano , Godfrey Musuka , Roda Madziva , Noah Mataruse , Elliot Mbunge , Sphamandla Josias Nkambule , Enos Moyo","doi":"10.1016/j.vaccine.2026.128228","DOIUrl":"10.1016/j.vaccine.2026.128228","url":null,"abstract":"<div><h3>Background</h3><div>Despite global progress in childhood immunization, Sub-Saharan Africa (SSA) continues to report suboptimal coverage and high under-five mortality. This systematic review and meta-analysis assessed the prevalence and determinants of full immunization among children under five in SSA between 2013 and 2025.</div></div><div><h3>Methods</h3><div>We systematically searched six electronic databases for studies published between January 2013 and May 2025 that reported the prevalence and/or determinants of full immunization in SSA. Eligible studies were original, peer-reviewed quantitative research. Data were analysed using random-effects meta-analysis, with subgroup and sensitivity analyses conducted to explore heterogeneity. Determinants were synthesised using pooled odds ratios (ORs) where applicable.</div></div><div><h3>Results</h3><div>Thirty-one studies comprising 299,898 children were included. The pooled prevalence of full immunization was 51% (95% CI: 45%–58%), with substantial heterogeneity (I<sup>2</sup> = 100%). Prevalence varied widely across studies from 6% to 96%. Subgroup analyses revealed lower coverage in recent years and in studies with larger sample sizes. Key positive determinants of full immunization included maternal education (OR = 2.70), paternal education (OR = 2.48), antenatal care attendance (OR = 0.23 for non-attendance), institutional delivery (OR = 2.99), and household wealth (OR = 2.45). Children in rural areas (OR = 0.55) and those with mothers of higher parity (OR = 0.67) were less likely to be fully immunised.</div></div><div><h3>Conclusion</h3><div>Full immunization coverage in SSA remains well below global targets, with wide disparities by country, socioeconomic status, and maternal healthcare utilization. Strengthening maternal health services, improving education, and addressing health system barriers are critical to improving coverage and reducing preventable child deaths in the region.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128228"},"PeriodicalIF":4.5,"publicationDate":"2026-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145981900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-17DOI: 10.1016/j.vaccine.2026.128220
Pranaya M. Mishra , Suman Chaudhary , Ravi S. Manhas , Sakshi R. Lokwani , Diksha Sharma , Dipak Dutta , Manoj K. Baranwal , Ravi P.N. Mishra
Staphylococcus aureus is a leading cause of nosocomial infections, including sepsis, bacteraemia, pneumonia, and endocarditis, and continues to pose a major public health challenge due to escalating multidrug resistance and the absence of an effective vaccine. To address this unmet clinical need, we employed a machine learning–guided reverse vaccinology approach to systematically interrogate the S. aureus proteome for novel vaccine antigens. This strategy led to the identification of eight previously uncharacterized hypothetical proteins with predicted immunogenic properties. Among these, SAUSA300_1684 protein (designated IMTS8) was prioritized for detailed translational evaluation. IMTS8 was found to be highly conserved across major clinical S. aureus lineages and expressed throughout growth phases of the methicillin-resistant strain USA300-FPR3757. Analysis of the surface-shaved proteome revealed that IMTS8 is likely exposed on the bacterial surface, a finding further substantiated by immunofluorescence microscopy. Immunization of mice with recombinant adjuvanted IMTS8 elicited strong antigen-specific IgG responses and conferred near-complete protection in a murine staphylococcal infection model. Collectively, these findings identify IMTS8 as a promising protein subunit vaccine candidate for the prevention of multidrug-resistant Staphylococcus aureus infections. In addition, this study highlights the translational utility of machine learning–based reverse vaccinology as an effective platform for accelerating antigen discovery against antimicrobial-resistant bacterial pathogens.
{"title":"A novel hypothetical protein (SAUSA300_1684) confers excellent protection against multi-drug-resistant Staphylococcus aureus infection in the murine model","authors":"Pranaya M. Mishra , Suman Chaudhary , Ravi S. Manhas , Sakshi R. Lokwani , Diksha Sharma , Dipak Dutta , Manoj K. Baranwal , Ravi P.N. Mishra","doi":"10.1016/j.vaccine.2026.128220","DOIUrl":"10.1016/j.vaccine.2026.128220","url":null,"abstract":"<div><div><em>Staphylococcus aureus</em> is a leading cause of nosocomial infections, including sepsis, bacteraemia, pneumonia, and endocarditis, and continues to pose a major public health challenge due to escalating multidrug resistance and the absence of an effective vaccine. To address this unmet clinical need, we employed a machine learning–guided reverse vaccinology approach to systematically interrogate the <em>S. aureus</em> proteome for novel vaccine antigens. This strategy led to the identification of eight previously uncharacterized hypothetical proteins with predicted immunogenic properties. Among these, SAUSA300_1684 protein (designated IMTS8) was prioritized for detailed translational evaluation. IMTS8 was found to be highly conserved across major clinical <em>S. aureus</em> lineages and expressed throughout growth phases of the methicillin-resistant strain USA300-FPR3757. Analysis of the surface-shaved proteome revealed that IMTS8 is likely exposed on the bacterial surface, a finding further substantiated by immunofluorescence microscopy. Immunization of mice with recombinant adjuvanted IMTS8 elicited strong antigen-specific IgG responses and conferred near-complete protection in a murine staphylococcal infection model. Collectively, these findings identify IMTS8 as a promising protein subunit vaccine candidate for the prevention of multidrug-resistant <em>Staphylococcus aureus</em> infections. In addition, this study highlights the translational utility of machine learning–based reverse vaccinology as an effective platform for accelerating antigen discovery against antimicrobial-resistant bacterial pathogens.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128220"},"PeriodicalIF":4.5,"publicationDate":"2026-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145981904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-17DOI: 10.1016/j.vaccine.2026.128227
L. Yesenia Rodríguez-Tanta , Raquel Delgado-Escalante , Tania del Pilar Solis-Yucra , Enrique Cachay Rojas , Guisela Alva Lozada , Liz E. Veramendi-Espinoza , Vladimir Espinoza-Ildefonso , Violeta Saromo-Meléndez , Anaís Lazarte-Ramos , Juan Carlos Aldave , Mariela Milla Pimentel , Carla Garcia Torres , Claudia Rentería Valdiviezo , Víctor E. Lechuga-Noa
Introduction
The inactivated SARS-CoV-2 vaccine (BBIBP-CorV) was first introduced in Peru among healthcare workers. We evaluated its safety profile by analyzing adverse events following immunization (AEFI) reports and conducting clinical and causality assessments for cases meeting criteria for adverse events of special interest (AESI) and serious adverse events (SAEs).
Methods
We conducted a retrospective analysis using data from the Pharmacovigilance Center of EsSalud. We identified, estimated the overall reporting rate, and described key characteristics of AEFI reports, including differences by gender and age group. Clinicians trained in vaccine safety performed clinical assessments for AESIs and SAEs based on medical records and conducted formal causality assessments.
Results
From February to August 2021, we identified 2280 AEFI reports (1052 per 100,000 doses; 95% CI 1009–1097), corresponding to 4376 adverse event terms. Of these, 22 met AESI criteria, with only two anaphylaxis cases causally linked to the vaccine (A1). The remaining 4354 events were grouped into 14 MedDRA SOC categories, with nervous system disorders (30%) and injection site reactions (11%) most frequent. Gastrointestinal events were more common in women (12.6% vs. 7.9%, p < 0.001), while men reported more general disorders (16% vs. 10.9%, p < 0.001). Adults ≥65 years reported more vascular and eye disorders. Fifteen events were categorized as SAEs and classified as category C.
Conclusions
This first post-marketing safety evaluation of BBIBP-CorV among Peruvian healthcare personnel found a low AEFI reporting rate, with mostly mild events. Access to medical records enabled accurate assessment, supporting local pharmacovigilance and public health decision-making.
灭活SARS-CoV-2疫苗(BBIBP-CorV)首先在秘鲁的卫生保健工作者中引入。我们通过分析免疫后不良事件(AEFI)报告,并对符合特殊不良事件(AESI)和严重不良事件(SAEs)标准的病例进行临床和因果关系评估,来评估其安全性。方法回顾性分析山东省药物警戒中心的资料。我们确定、估计了总体报告率,并描述了AEFI报告的关键特征,包括性别和年龄组的差异。接受过疫苗安全培训的临床医生根据医疗记录对aesi和SAEs进行临床评估,并进行正式的因果关系评估。从2021年2月至8月,我们共发现2280例AEFI报告(1052 / 10万剂;95% CI 1009-1097),对应4376例不良事件。其中22例符合AESI标准,只有2例过敏反应与疫苗有因果关系(A1)。其余4354例事件分为14个MedDRA SOC类别,其中神经系统疾病(30%)和注射部位反应(11%)最为常见。胃肠道事件在女性中更常见(12.6%对7.9%,p < 0.001),而男性报告更多的一般疾病(16%对10.9%,p < 0.001)。≥65岁的成年人报告了更多的血管和眼部疾病。结论首次对秘鲁医护人员进行的BBIBP-CorV上市后安全性评估发现,AEFI报告率较低,且大多为轻度事件。获得医疗记录有助于进行准确的评估,支持当地的药物警戒和公共卫生决策。
{"title":"Post-marketing safety surveillance of the BBIBP-CorV (Sinopharm) COVID-19 vaccine in Peruvian healthcare workers: A retrospective analysis of a Pharmacovigilance Center","authors":"L. Yesenia Rodríguez-Tanta , Raquel Delgado-Escalante , Tania del Pilar Solis-Yucra , Enrique Cachay Rojas , Guisela Alva Lozada , Liz E. Veramendi-Espinoza , Vladimir Espinoza-Ildefonso , Violeta Saromo-Meléndez , Anaís Lazarte-Ramos , Juan Carlos Aldave , Mariela Milla Pimentel , Carla Garcia Torres , Claudia Rentería Valdiviezo , Víctor E. Lechuga-Noa","doi":"10.1016/j.vaccine.2026.128227","DOIUrl":"10.1016/j.vaccine.2026.128227","url":null,"abstract":"<div><h3>Introduction</h3><div>The inactivated SARS-CoV-2 vaccine (BBIBP-CorV) was first introduced in Peru among healthcare workers. We evaluated its safety profile by analyzing adverse events following immunization (AEFI) reports and conducting clinical and causality assessments for cases meeting criteria for adverse events of special interest (AESI) and serious adverse events (SAEs).</div></div><div><h3>Methods</h3><div>We conducted a retrospective analysis using data from the Pharmacovigilance Center of EsSalud. We identified, estimated the overall reporting rate, and described key characteristics of AEFI reports, including differences by gender and age group. Clinicians trained in vaccine safety performed clinical assessments for AESIs and SAEs based on medical records and conducted formal causality assessments.</div></div><div><h3>Results</h3><div>From February to August 2021, we identified 2280 AEFI reports (1052 per 100,000 doses; 95% CI 1009–1097), corresponding to 4376 adverse event terms. Of these, 22 met AESI criteria, with only two anaphylaxis cases causally linked to the vaccine (A1). The remaining 4354 events were grouped into 14 MedDRA SOC categories, with nervous system disorders (30%) and injection site reactions (11%) most frequent. Gastrointestinal events were more common in women (12.6% vs. 7.9%, <em>p</em> < 0.001), while men reported more general disorders (16% vs. 10.9%, p < 0.001). Adults ≥65 years reported more vascular and eye disorders. Fifteen events were categorized as SAEs and classified as category C.</div></div><div><h3>Conclusions</h3><div>This first post-marketing safety evaluation of BBIBP-CorV among Peruvian healthcare personnel found a low AEFI reporting rate, with mostly mild events. Access to medical records enabled accurate assessment, supporting local pharmacovigilance and public health decision-making.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128227"},"PeriodicalIF":4.5,"publicationDate":"2026-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145981901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-16DOI: 10.1016/j.vaccine.2026.128235
Ohseok Jeong , Wooyoung Choi , Hyebin Ahn , Seonghyun Lee , Yong Wook Park , Hun Kim , Jae-Hwan Nam
Single Radial Immunodiffusion (SRID) assay remains the gold standard for determining influenza vaccine potency. Accurate SRID assays require high-purity antigens and strain-specific antisera that closely match circulating viruses. However, mutations in influenza viruses propagated in traditional egg-based systems affect antigenicity and assay accuracy. Therefore, we optimized bromelain-cleaved hemagglutinin (BHA) production from cell culture-derived influenza viruses, specifically targeting A/H3N2 and B/Victoria lineage strains. We employed a sequential enzymatic digestion strategy and successfully generated highly purified BHA with improved antigen yield and minimal neuraminidase contamination. The resulting antisera demonstrated strong, strain-specific reactivity. Subsequent SRID assays confirmed that homologous antigen–antiserum pairs derived from cell culture-derived materials provided significantly more accurate hemagglutinin quantification than the heterologous or egg-derived combinations. These findings highlight the need to match antigen and antiserum sources. Further, cell culture-derived reagents could be used to enhance assay reliability, advancing influenza vaccine standardization and quality control in cell-based vaccine production. By demonstrating the importance of antigen–antiserum matching and optimizing BHA production from cell culture-derived influenza viruses, this study establishes a practical foundation for improving the reliability of SRID-based potency testing and advancing the standardization of next-generation influenza vaccines.
{"title":"Bromelain-cleaved hemagglutinin production from cell culture-derived influenza viruses enhances vaccine potency quantification by single radial immunodiffusion assay","authors":"Ohseok Jeong , Wooyoung Choi , Hyebin Ahn , Seonghyun Lee , Yong Wook Park , Hun Kim , Jae-Hwan Nam","doi":"10.1016/j.vaccine.2026.128235","DOIUrl":"10.1016/j.vaccine.2026.128235","url":null,"abstract":"<div><div>Single Radial Immunodiffusion (SRID) assay remains the gold standard for determining influenza vaccine potency. Accurate SRID assays require high-purity antigens and strain-specific antisera that closely match circulating viruses. However, mutations in influenza viruses propagated in traditional egg-based systems affect antigenicity and assay accuracy. Therefore, we optimized bromelain-cleaved hemagglutinin (BHA) production from cell culture-derived influenza viruses, specifically targeting A/H3N2 and B/Victoria lineage strains. We employed a sequential enzymatic digestion strategy and successfully generated highly purified BHA with improved antigen yield and minimal neuraminidase contamination. The resulting antisera demonstrated strong, strain-specific reactivity. Subsequent SRID assays confirmed that homologous antigen–antiserum pairs derived from cell culture-derived materials provided significantly more accurate hemagglutinin quantification than the heterologous or egg-derived combinations. These findings highlight the need to match antigen and antiserum sources. Further, cell culture-derived reagents could be used to enhance assay reliability, advancing influenza vaccine standardization and quality control in cell-based vaccine production. By demonstrating the importance of antigen–antiserum matching and optimizing BHA production from cell culture-derived influenza viruses, this study establishes a practical foundation for improving the reliability of SRID-based potency testing and advancing the standardization of next-generation influenza vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128235"},"PeriodicalIF":4.5,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145981903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-16DOI: 10.1016/j.vaccine.2026.128208
Ahamed Lazim Vattoth , Mary S. Hayney , Amir Masoud Forati , Brandy Warren , Raj Kalkeri , Miranda R. Cai , Zhaohui Cai , MingZhu Zhu , Shane Cloney-Clark , Joyce S. Plested , Sandesh Parajuli , Freddy Caldera
Introduction
Immunosuppressed individuals are at increased risk of coronavirus disease (COVID-19). Although mRNA vaccines have shown efficacy in these populations, data on protein-based vaccines remain limited. We evaluated the immunogenicity and safety of Novavax COVID-19 vaccine (NVX-CoV2601) in immunosuppressed patients.
Methods
This single-center, prospective ARMOR study included adults with inflammatory bowel disease (IBD) or solid organ transplant recipients receiving immunosuppressive therapy who had received ≥3 prior COVID-19 vaccine doses. Participants received one NVX-CoV2601 booster with follow-up at one and six months. The primary outcome was change in humoral immunogenicity from baseline to one month post-vaccination.
Results
Twenty-one immunosuppressed patients (18 IBD, 3 solid organ transplant recipients) were enrolled and compared with 57 age/sex-matched healthy controls. In ARMOR participants, anti-spike IgG GMT increased significantly post-immunization (22,969 to 66,639 EU/mL; 2.9-fold increase, p = 0.001). Healthy controls increased from 54,812 to 129,813 EU/mL (2.4-fold increase; p < 0.001). After baseline adjustment, no significant difference existed between groups at day 28. At 6 months, antibodies waned faster in immunosuppressed subjects. NVX-CoV2601 was well tolerated without IBD flares or organ rejection.
Conclusion
NVX-CoV2601 was safe and immunogenic with similar humoral responses compared to healthy controls, making it a viable alternative for immunosuppressed patients.
{"title":"Immunogenicity and safety of a recombinant spike protein COVID vaccine in patients with inflammatory bowel disease and transplant recipient","authors":"Ahamed Lazim Vattoth , Mary S. Hayney , Amir Masoud Forati , Brandy Warren , Raj Kalkeri , Miranda R. Cai , Zhaohui Cai , MingZhu Zhu , Shane Cloney-Clark , Joyce S. Plested , Sandesh Parajuli , Freddy Caldera","doi":"10.1016/j.vaccine.2026.128208","DOIUrl":"10.1016/j.vaccine.2026.128208","url":null,"abstract":"<div><h3>Introduction</h3><div>Immunosuppressed individuals are at increased risk of coronavirus disease (COVID-19). Although mRNA vaccines have shown efficacy in these populations, data on protein-based vaccines remain limited. We evaluated the immunogenicity and safety of Novavax COVID-19 vaccine (NVX-CoV2601) in immunosuppressed patients.</div></div><div><h3>Methods</h3><div>This single-center, prospective ARMOR study included adults with inflammatory bowel disease (IBD) or solid organ transplant recipients receiving immunosuppressive therapy who had received ≥3 prior COVID-19 vaccine doses. Participants received one NVX-CoV2601 booster with follow-up at one and six months. The primary outcome was change in humoral immunogenicity from baseline to one month post-vaccination.</div></div><div><h3>Results</h3><div>Twenty-one immunosuppressed patients (18 IBD, 3 solid organ transplant recipients) were enrolled and compared with 57 age/sex-matched healthy controls. In ARMOR participants, anti-spike IgG GMT increased significantly post-immunization (22,969 to 66,639 EU/mL; 2.9-fold increase, <em>p</em> = 0.001). Healthy controls increased from 54,812 to 129,813 EU/mL (2.4-fold increase; <em>p</em> < 0.001). After baseline adjustment, no significant difference existed between groups at day 28. At 6 months, antibodies waned faster in immunosuppressed subjects. NVX-CoV2601 was well tolerated without IBD flares or organ rejection.</div></div><div><h3>Conclusion</h3><div>NVX-CoV2601 was safe and immunogenic with similar humoral responses compared to healthy controls, making it a viable alternative for immunosuppressed patients.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128208"},"PeriodicalIF":4.5,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145981902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-15DOI: 10.1016/j.vaccine.2026.128250
Rolando Paternina-De La Ossa, Maria Carolina Oliveira, Jorge Alberto Achcar, Djúlio César Zanin- Silva, Thalita Cristina Mello Costa, Luiz Guilherme Darrigo-Junior, Fernando Bellissimo-Rodrigues
Introduction
Among hematopoietic stem cell transplant (HSCT) recipients, morbidity and mortality are largely related to infectious diseases, many of which are vaccine-preventable. The present study aimed to assess the immune response of HSCT patients to the tetanus, diphtheria, and acellular pertussis inactivated vaccine (Tdap).
Patients and methods
This quasi-experimental study, with individually matched data collection in HSCT patients from January 2018 to December 2020, evaluated sixteen patients for their immune response to each of the Tdap components. The immunization schedule included three doses of Tdap, with a minimum interval of 30 days between each dose, starting at 6 months post-transplantation. Immune competence was measured before vaccination by quantifying CD4+, CD8+, and CD19+ frequencies, as well as serum immunoglobulin levels.
Results
After the complete immunization schedule, for diphtheria, we observed a Geometric Mean Concentration (GMC) rise from 0.2509 IU/mL at baseline to 0.7544 IU/mL post-vaccination, p = 0.001. For tetanus, GMC increased from 0.353 to 1.153 IU/mL, p = 0.001. For pertussis, GMC was 31.9 IU/mL before and 99.3 IU/mL after vaccination. Due to the non-normal distribution of pertussis data and a marginal frequentist result (p = 0.077), we used Bayesian analysis assuming an exponential distribution. This model identified a significant increase in antibody levels, with a posterior mean difference (θ) of 58.55 IU/mL and a 95% Credibility Interval (23.9–109.0) that excluded zero, confirming an adequate vaccine response.
For the entire Tdap vaccination period, CD4+ cell frequencies remained low, while CD8+, CD19+, and immunoglobulin titers remained within normal range. Immune responses to each of the Tdap vaccine components were not affected (p > 0.05) by any of the clinical, demographic, or immunological variables assessed.
Conclusions
The overall Tdap vaccine post-transplant response was considered adequate for diphtheria, tetanus, and pertussis. These findings highlight the immune response to Tdap in transplanted patients and may inform future vaccination guidelines.
在造血干细胞移植(HSCT)受者中,发病率和死亡率在很大程度上与传染病有关,其中许多是可以通过疫苗预防的。本研究旨在评估造血干细胞移植患者对破伤风、白喉和无细胞百日咳灭活疫苗(Tdap)的免疫反应。患者和方法这项准实验研究收集了2018年1月至2020年12月HSCT患者的单独匹配数据,评估了16名患者对每种Tdap成分的免疫反应。免疫计划包括三剂Tdap,每次剂量之间至少间隔30天,从移植后6个月开始。免疫能力在接种前通过定量CD4+、CD8+和CD19+频率以及血清免疫球蛋白水平来测定。结果在完成免疫计划后,我们观察到白喉的几何平均浓度(GMC)从基线时的0.2509 IU/mL上升到接种后的0.7544 IU/mL, p = 0.001。破伤风的GMC由0.353增加到1.153 IU/mL, p = 0.001。百日咳接种前GMC为31.9 IU/mL,接种后GMC为99.3 IU/mL。由于百日咳数据的非正态分布和边际频率结果(p = 0.077),我们使用假设指数分布的贝叶斯分析。该模型发现抗体水平显著增加,后验平均差(θ)为58.55 IU/mL, 95%可信区间(23.9-109.0)排除零,证实疫苗反应足够。在整个Tdap疫苗接种期间,CD4+细胞频率保持较低,而CD8+、CD19+和免疫球蛋白滴度保持在正常范围内。对每一种百白破疫苗成分的免疫应答不受任何临床、人口统计学或免疫学变量的影响(p > 0.05)。结论Tdap疫苗移植后的总体反应被认为是足够的,用于白喉、破伤风和百日咳。这些发现强调了移植患者对Tdap的免疫反应,并可能为未来的疫苗接种指南提供信息。
{"title":"Immunological responses to tetanus, diphtheria, pertussis (Tdap) vaccine in Brazilian hematopoietic stem cell transplant recipients","authors":"Rolando Paternina-De La Ossa, Maria Carolina Oliveira, Jorge Alberto Achcar, Djúlio César Zanin- Silva, Thalita Cristina Mello Costa, Luiz Guilherme Darrigo-Junior, Fernando Bellissimo-Rodrigues","doi":"10.1016/j.vaccine.2026.128250","DOIUrl":"10.1016/j.vaccine.2026.128250","url":null,"abstract":"<div><h3>Introduction</h3><div>Among hematopoietic stem cell transplant (HSCT) recipients, morbidity and mortality are largely related to infectious diseases, many of which are vaccine-preventable. The present study aimed to assess the immune response of HSCT patients to the tetanus, diphtheria, and acellular pertussis inactivated vaccine (Tdap).</div></div><div><h3>Patients and methods</h3><div>This quasi-experimental study, with individually matched data collection in HSCT patients from January 2018 to December 2020, evaluated sixteen patients for their immune response to each of the Tdap components. The immunization schedule included three doses of Tdap, with a minimum interval of 30 days between each dose, starting at 6 months post-transplantation. Immune competence was measured before vaccination by quantifying CD4+, CD8+, and CD19+ frequencies, as well as serum immunoglobulin levels.</div></div><div><h3>Results</h3><div>After the complete immunization schedule, for diphtheria, we observed a Geometric Mean Concentration (GMC) rise from 0.2509 IU/mL at baseline to 0.7544 IU/mL post-vaccination, <em>p</em> = 0.001. For tetanus, GMC increased from 0.353 to 1.153 IU/mL, p = 0.001. For pertussis, GMC was 31.9 IU/mL before and 99.3 IU/mL after vaccination. Due to the non-normal distribution of pertussis data and a marginal frequentist result (<em>p</em> = 0.077), we used Bayesian analysis assuming an exponential distribution. This model identified a significant increase in antibody levels, with a posterior mean difference (θ) of 58.55 IU/mL and a 95% Credibility Interval (23.9–109.0) that excluded zero, confirming an adequate vaccine response.</div><div>For the entire Tdap vaccination period, CD4+ cell frequencies remained low, while CD8+, CD19+, and immunoglobulin titers remained within normal range. Immune responses to each of the Tdap vaccine components were not affected (<em>p</em> > 0.05) by any of the clinical, demographic, or immunological variables assessed.</div></div><div><h3>Conclusions</h3><div>The overall Tdap vaccine post-transplant response was considered adequate for diphtheria, tetanus, and pertussis. These findings highlight the immune response to Tdap in transplanted patients and may inform future vaccination guidelines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128250"},"PeriodicalIF":4.5,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145969316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-15DOI: 10.1016/j.vaccine.2026.128206
Amélie Mallet , Louis-Baptiste Jaunay , Philippe Jaury , Henri Partouche
As in other countries, France has implemented unprecedented measures to restrict freedoms to control the COVID-19 pandemic. The rapid development and widespread availability of new vaccines in early 2021 have undoubtedly saved many lives. However, despite the implementation and maintenance of a strong incentive policy over several months, more than 6.5% of the French population eligible for vaccination had not been vaccinated in August 2022,
Objectives
The aim of this study was to explore the mechanisms and dynamics of vaccine refusal among individuals more than one year after they became eligible for COVID-19 vaccination.
Methods
A qualitative grounded theory-based survey was conducted between April 2022 and June 2023. Participants were recruited from various French regions to maximize sample diversity, excluding anti-vaccine activists, until sufficient data were collected. Coding and analysis were triangulated according to the COREQ criteria.
Findings
Ten in-depth interviews with a mean duration of 57 min (median: 54 min) were conducted. None of the participants reported refusing all vaccines. However, most had been scarred by past vaccine controversies in France. Common features of vaccine hesitancy were observed, including concerns about COVID-19 vaccine safety and a lack of perceived severity of personal infection. However, resistance to social norms and a strong emphasis on individual freedoms were particularly reported. Being labeled as unvaccinated, combined with the questioning of fundamental values, contributed to participants maintaining their position.
Conclusion
Although vaccination was crucial for controlling the pandemic, this study highlighted the need to implement careful, targeted communication strategies to prevent long-term negative effects of the growing number of vaccine-reluctant individuals on community health.
{"title":"Vaccine refusal during the COVID-19 pandemic: A qualitative study","authors":"Amélie Mallet , Louis-Baptiste Jaunay , Philippe Jaury , Henri Partouche","doi":"10.1016/j.vaccine.2026.128206","DOIUrl":"10.1016/j.vaccine.2026.128206","url":null,"abstract":"<div><div>As in other countries, France has implemented unprecedented measures to restrict freedoms to control the COVID-19 pandemic. The rapid development and widespread availability of new vaccines in early 2021 have undoubtedly saved many lives. However, despite the implementation and maintenance of a strong incentive policy over several months, more than 6.5% of the French population eligible for vaccination had not been vaccinated in August 2022,</div></div><div><h3>Objectives</h3><div>The aim of this study was to explore the mechanisms and dynamics of vaccine refusal among individuals more than one year after they became eligible for COVID-19 vaccination.</div></div><div><h3>Methods</h3><div>A qualitative grounded theory-based survey was conducted between April 2022 and June 2023. Participants were recruited from various French regions to maximize sample diversity, excluding anti-vaccine activists, until sufficient data were collected. Coding and analysis were triangulated according to the COREQ criteria.</div></div><div><h3>Findings</h3><div>Ten in-depth interviews with a mean duration of 57 min (median: 54 min) were conducted. None of the participants reported refusing all vaccines. However, most had been scarred by past vaccine controversies in France. Common features of vaccine hesitancy were observed, including concerns about COVID-19 vaccine safety and a lack of perceived severity of personal infection. However, resistance to social norms and a strong emphasis on individual freedoms were particularly reported. Being labeled as unvaccinated, combined with the questioning of fundamental values, contributed to participants maintaining their position.</div></div><div><h3>Conclusion</h3><div>Although vaccination was crucial for controlling the pandemic, this study highlighted the need to implement careful, targeted communication strategies to prevent long-term negative effects of the growing number of vaccine-reluctant individuals on community health.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"74 ","pages":"Article 128206"},"PeriodicalIF":4.5,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145979776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-15DOI: 10.1016/j.vaccine.2026.128234
Philippe De Wals , Jesse Papenburg , Rodica Gilca , Nicholas Brousseau
{"title":"Are hemagglutinin-only influenza vaccines as effective as conventional influenza vaccines against severe infection?","authors":"Philippe De Wals , Jesse Papenburg , Rodica Gilca , Nicholas Brousseau","doi":"10.1016/j.vaccine.2026.128234","DOIUrl":"10.1016/j.vaccine.2026.128234","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"74 ","pages":"Article 128234"},"PeriodicalIF":4.5,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145979868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}