Pub Date : 2026-02-03DOI: 10.1016/j.vaccine.2026.128291
Huy Quang Quach , Lara I. Teodoro , Tamar Ratishvili , Inna G. Ovsyannikova , Sara P. Jones , Iype Joseph , John B. Johnson , M. Radhakrishna Pillai , Gregory A. Poland , Joshy Jacob , Richard B. Kennedy
Mumps and rubella are highly contagious, vaccine-preventable diseases; however, India's National Immunization Program prioritizes rubella while excluding mumps. In this cross-sectional study, we measured mumps- and rubella-specific IgG seroprevalence in 508 children (49.6% female) from Kerala and evaluated demographic associations. Seropositivity was 78.5% (95% CI, 74.8–81.9%) for mumps and 99.4% (95% CI, 98.3–99.8%) for rubella. Mumps IgG titers were significantly higher in females (p = 0.0061) and increased with vaccine doses (p < 0.001), whereas rubella IgG titers showed no such associations (p > 0.05). IgG titers for both mumps (r = −0.13, p = 0.0043) and rubella (r = −0.23, p < 0.001) declined with time since vaccination, indicating waning immunity. The contrast between high rubella and lower mumps immunity likely reflects differences in vaccination prioritization and support the inclusion of mumps-containing vaccines into India's National Immunization Program, ideally through universal adoption of the measles-mumps-rubella (MMR) vaccine.
腮腺炎和风疹是高度传染性、可通过疫苗预防的疾病；然而，印度的国家免疫规划优先考虑风疹，而不包括腮腺炎。在这项横断面研究中，我们测量了喀拉拉邦508名儿童（49.6%为女性）的腮腺炎和风疹特异性IgG血清阳性率，并评估了人口统计学相关性。腮腺炎血清阳性率为78.5% (95% CI, 74.8-81.9%)，风疹血清阳性率为99.4% （95% CI, 98.3-99.8%）。女性流行性腮腺炎IgG滴度显著升高（p = 0.0061），且随疫苗剂量增加而升高（p 0.05）。腮腺炎（r = -0.13, p = 0.0043）和风疹(r = -0.23, p
{"title":"Seroprevalence of mumps and rubella antibodies among Indian children: evidence of a mumps immunity gap","authors":"Huy Quang Quach , Lara I. Teodoro , Tamar Ratishvili , Inna G. Ovsyannikova , Sara P. Jones , Iype Joseph , John B. Johnson , M. Radhakrishna Pillai , Gregory A. Poland , Joshy Jacob , Richard B. Kennedy","doi":"10.1016/j.vaccine.2026.128291","DOIUrl":"10.1016/j.vaccine.2026.128291","url":null,"abstract":"<div><div>Mumps and rubella are highly contagious, vaccine-preventable diseases; however, India's National Immunization Program prioritizes rubella while excluding mumps. In this cross-sectional study, we measured mumps- and rubella-specific IgG seroprevalence in 508 children (49.6% female) from Kerala and evaluated demographic associations. Seropositivity was 78.5% (95% CI, 74.8–81.9%) for mumps and 99.4% (95% CI, 98.3–99.8%) for rubella. Mumps IgG titers were significantly higher in females (<em>p</em> = 0.0061) and increased with vaccine doses (<em>p</em> < 0.001), whereas rubella IgG titers showed no such associations (<em>p</em> > 0.05). IgG titers for both mumps (<em>r</em> = −0.13, <em>p</em> = 0.0043) and rubella (<em>r</em> = −0.23, <em>p</em> < 0.001) declined with time since vaccination, indicating waning immunity. The contrast between high rubella and lower mumps immunity likely reflects differences in vaccination prioritization and support the inclusion of mumps-containing vaccines into India's National Immunization Program, ideally through universal adoption of the measles-mumps-rubella (MMR) vaccine.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128291"},"PeriodicalIF":4.5,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146121543","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 : 2026-02-02DOI: 10.1016/j.vaccine.2026.128294
Sónia T. Almeida , A. Cristina Paulo , Alexandra S. Simões , Sara Handem , Bárbara Ferreira , Mariana F. Caleiro , Susana Morais , António-Brito Avô , Hermínia de Lencastre , Raquel Sá-Leão
Streptococcus pneumoniae remains a major cause of infectious disease globally, with young children serving as key reservoirs for transmission. This study evaluated pneumococcal carriage and serotype distribution among young children in Portugal, six months after the lifting of COVID-19 public health measures and seven years after the introduction of the 13-valent pneumococcal conjugate vaccine (PCV13) into the National Immunization Plan.
A cross-sectional study was conducted in late 2022 among children aged 18 months to 6 years attending day-care centers in an urban region. Saliva samples, vaccination records, and demographic/clinical data were collected. Pneumococcal carriage was determined by qPCR targeting lytA and piaB genes. Molecular serotyping of 65 serotypes/serogroups was performed. New primers/probes were designed and validated for serotypes/serogroups 5, 7A/F, 9A/V, 9N/L, 17F and 33A/F/37, expanding the range of serotypes that could be reliably identified.
Among 584 children, 34.9% were pneumococcal carriers. Carriage of PCV13 serotypes was low, except for serotypes 3 (7.8%) and 19F (5.4%). Among non-PCV13 serotypes, 23A (10.8%), 15B/C (10.3%), 23B (9.8%), and 11A/D (9.3%) were the most frequent. Theoretical coverage of PCV13, PCV15, and PCV20 was 17.6%, 23.0%, and 46.1%, respectively. Children 4–6 years were nearly 15 times more likely to carry PCV13 serotypes than those aged 18–24 months (p = 0.012).
Six months post-COVID-19 restrictions lifting, serotype distribution largely resembled the pre-pandemic period. Although saliva sampling had lower sensitivity than nasopharyngeal swabbing for estimating overall pneumococcal carriage prevalence, it was particularly useful to assess serotype distribution. Importantly, in a context where nasopharyngeal swabbing was met with reluctance, saliva sampling emerged as a practical, effective, and non-invasive alternative for pneumococcal serotype carriage surveillance.
{"title":"Pneumococcal carriage and serotype distribution in Portuguese children six months after the lifting of COVID-19 restrictions: rise in serotype 3 amid stable non-vaccine serotypes","authors":"Sónia T. Almeida , A. Cristina Paulo , Alexandra S. Simões , Sara Handem , Bárbara Ferreira , Mariana F. Caleiro , Susana Morais , António-Brito Avô , Hermínia de Lencastre , Raquel Sá-Leão","doi":"10.1016/j.vaccine.2026.128294","DOIUrl":"10.1016/j.vaccine.2026.128294","url":null,"abstract":"<div><div><em>Streptococcus pneumoniae</em> remains a major cause of infectious disease globally, with young children serving as key reservoirs for transmission. This study evaluated pneumococcal carriage and serotype distribution among young children in Portugal, six months after the lifting of COVID-19 public health measures and seven years after the introduction of the 13-valent pneumococcal conjugate vaccine (PCV13) into the National Immunization Plan.</div><div>A cross-sectional study was conducted in late 2022 among children aged 18 months to 6 years attending day-care centers in an urban region. Saliva samples, vaccination records, and demographic/clinical data were collected. Pneumococcal carriage was determined by qPCR targeting <em>lytA</em> and <em>piaB</em> genes. Molecular serotyping of 65 serotypes/serogroups was performed. New primers/probes were designed and validated for serotypes/serogroups 5, 7A/F, 9A/V, 9N/L, 17F and 33A/F/37, expanding the range of serotypes that could be reliably identified.</div><div>Among 584 children, 34.9% were pneumococcal carriers. Carriage of PCV13 serotypes was low, except for serotypes 3 (7.8%) and 19F (5.4%). Among non-PCV13 serotypes, 23A (10.8%), 15B/C (10.3%), 23B (9.8%), and 11A/D (9.3%) were the most frequent. Theoretical coverage of PCV13, PCV15, and PCV20 was 17.6%, 23.0%, and 46.1%, respectively. Children 4–6 years were nearly 15 times more likely to carry PCV13 serotypes than those aged 18–24 months (<em>p</em> = 0.012).</div><div>Six months post-COVID-19 restrictions lifting, serotype distribution largely resembled the pre-pandemic period. Although saliva sampling had lower sensitivity than nasopharyngeal swabbing for estimating overall pneumococcal carriage prevalence, it was particularly useful to assess serotype distribution. Importantly, in a context where nasopharyngeal swabbing was met with reluctance, saliva sampling emerged as a practical, effective, and non-invasive alternative for pneumococcal serotype carriage surveillance.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128294"},"PeriodicalIF":4.5,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146098570","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 : 2026-02-02DOI: 10.1016/j.vaccine.2026.128281
Wen-Ling Hsu , Yang Jiao , Matthew Hvasta , Kristina N. Tran , Brennen T. Troyer , Wei-Chiao Huang , Brian Kuhlman , Andres Obregon-Henao , Jonathan F. Lovell
Tuberculosis (TB) remains a global health problem, providing motivation for improved vaccine approaches, such as subunit vaccines targeting specific Mycobacterium tuberculosis (M. tuberculosis) antigens. Ag85B is a protein involved in cell wall biosynthesis, is abundant in M. tuberculosis culture supernatants, and has been incorporated in several TB vaccines candidates. We observed low expression yields of Ag85B when expressed recombinantly in E. coli using a histidine-tag purification approach. To address this, we utilized the ThermoMPNN protein structure algorithm to predict several stabilizing mutations in Ag85B. Of these, a single mutation, D52W, significantly enhanced expression yield in E. coli with good storage stability. Ag85B-52W exhibited rapid binding to liposomes incorporating cobalt-porphyrin via his-tag interaction, resulting in suppression in reactivity with an anti-his-tag antibody (due to anchoring of the his-tag in the bilayer), while the surface-displayed protein remained reactive towards anti-Ag85B antibodies. Immunization with Ag85B-52W in a liposomal vaccine elicited antigen-specific antibody and T cell responses, resulting in reduced lung bacterial burden in mice following aerosol M. tuberculosis challenge.
Significance statement
A point mutation in the M. tuberculosis Ag85B protein, predicted by ThermoMPNN algorithm, enhanced its antigen expression yield in E. coli with good storage stability. Immunization with the Ag85B mutant with a liposome vaccine system in mice resulted in antigen-specific humoral and cellular response that protected mice against M. tuberculosis infection. This approach could facilitate the use of recombinant Ag85B in TB vaccine development.
{"title":"A point-mutated Ag85B antigen improves recombinant bacterial expression and protects mice from aerosol M. tuberculosis challenge","authors":"Wen-Ling Hsu , Yang Jiao , Matthew Hvasta , Kristina N. Tran , Brennen T. Troyer , Wei-Chiao Huang , Brian Kuhlman , Andres Obregon-Henao , Jonathan F. Lovell","doi":"10.1016/j.vaccine.2026.128281","DOIUrl":"10.1016/j.vaccine.2026.128281","url":null,"abstract":"<div><div>Tuberculosis (TB) remains a global health problem, providing motivation for improved vaccine approaches, such as subunit vaccines targeting specific <em>Mycobacterium tuberculosis</em> (<em>M. tuberculosis</em>) antigens. Ag85B is a protein involved in cell wall biosynthesis, is abundant in <em>M. tuberculosis</em> culture supernatants, and has been incorporated in several TB vaccines candidates. We observed low expression yields of Ag85B when expressed recombinantly in <em>E. coli</em> using a histidine-tag purification approach. To address this, we utilized the ThermoMPNN protein structure algorithm to predict several stabilizing mutations in Ag85B. Of these, a single mutation, D52W, significantly enhanced expression yield in <em>E. coli</em> with good storage stability. Ag85B-52W exhibited rapid binding to liposomes incorporating cobalt-porphyrin via his-tag interaction, resulting in suppression in reactivity with an anti-his-tag antibody (due to anchoring of the his-tag in the bilayer), while the surface-displayed protein remained reactive towards anti-Ag85B antibodies. Immunization with Ag85B-52W in a liposomal vaccine elicited antigen-specific antibody and T cell responses, resulting in reduced lung bacterial burden in mice following aerosol <em>M. tuberculosis</em> challenge.</div></div><div><h3>Significance statement</h3><div>A point mutation in the <em>M. tuberculosis</em> Ag85B protein, predicted by ThermoMPNN algorithm, enhanced its antigen expression yield in <em>E. coli</em> with good storage stability. Immunization with the Ag85B mutant with a liposome vaccine system in mice resulted in antigen-specific humoral and cellular response that protected mice against <em>M. tuberculosis</em> infection. This approach could facilitate the use of recombinant Ag85B in TB vaccine development.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128281"},"PeriodicalIF":4.5,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146098569","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 : 2026-01-30DOI: 10.1016/j.vaccine.2026.128256
Rachel Wittenauer , Parth D. Shah , Jennifer L. Bacci , Stephen J. Mooney , Andy Stergachis
Importance
Community pharmacists provide many important healthcare services, including routine adult vaccinations. However, an estimated 15.8 million people in the US live in pharmacy deserts and may lack access to these services. The relationship between pharmacy deserts and adult vaccine receipt has yet to be thoroughly explored empirically.
Objective
We evaluated the relationship between census tract-level pharmacy access and shingles vaccination receipt.
Design, setting, and participants
This propensity score matched analysis used 2022 vaccination data from seven collaborating State Departments of Health: Colorado, Louisiana, Massachusetts, Nevada, Oklahoma, Washington, and Wisconsin. Census tracts in those states were classified based on their access to community pharmacies in April 2022. The dataset for analysis contained 9652 census tracts representing 13.7 million adults aged 50+ years.
Exposure
Our primary exposure was whether a census tract was a “pharmacy desert”, defined as being both low-income and having low geographic access to pharmacies. Our secondary exposure was whether a tract had low geographic access to pharmacies regardless of income status of that tract.
Main outcomes
The primary outcome was completed shingles vaccinations per 1000 population age 50+ years in 2022.
Results
Pharmacy deserts had 0.4 fewer shingles vaccinations per 1000 population (p = 0.83; 95% CI -3.8, 3.6) compared to matched non-pharmacy-desert tracts. Our secondary analysis indicated that low-access tracts had 2.4 fewer vaccinations per 1000 population (p = 0.004, 95% CI: −3.9, −0.7).
Conclusions
Low pharmacy access is associated with lower rates of shingles vaccination. The definition of pharmacy desert that includes a low-income criterion may not add further precision in identifying areas with inadequate access to pharmacy-based vaccinations. Efforts at the state and national levels to prevent pharmacy closures and support pharmacists in delivering care may improve access to important pharmacy services such as vaccination.
{"title":"Pharmacy access and shingles vaccinations in the US: a propensity score matching analysis","authors":"Rachel Wittenauer , Parth D. Shah , Jennifer L. Bacci , Stephen J. Mooney , Andy Stergachis","doi":"10.1016/j.vaccine.2026.128256","DOIUrl":"10.1016/j.vaccine.2026.128256","url":null,"abstract":"<div><h3>Importance</h3><div>Community pharmacists provide many important healthcare services, including routine adult vaccinations. However, an estimated 15.8 million people in the US live in pharmacy deserts and may lack access to these services. The relationship between pharmacy deserts and adult vaccine receipt has yet to be thoroughly explored empirically.</div></div><div><h3>Objective</h3><div>We evaluated the relationship between census tract-level pharmacy access and shingles vaccination receipt.</div></div><div><h3>Design, setting, and participants</h3><div>This propensity score matched analysis used 2022 vaccination data from seven collaborating State Departments of Health: Colorado, Louisiana, Massachusetts, Nevada, Oklahoma, Washington, and Wisconsin. Census tracts in those states were classified based on their access to community pharmacies in April 2022. The dataset for analysis contained 9652 census tracts representing 13.7 million adults aged 50+ years.</div></div><div><h3>Exposure</h3><div>Our primary exposure was whether a census tract was a “pharmacy desert”, defined as being both low-income and having low geographic access to pharmacies. Our secondary exposure was whether a tract had low geographic access to pharmacies regardless of income status of that tract.</div></div><div><h3>Main outcomes</h3><div>The primary outcome was completed shingles vaccinations per 1000 population age 50+ years in 2022.</div></div><div><h3>Results</h3><div>Pharmacy deserts had 0.4 fewer shingles vaccinations per 1000 population (<em>p</em> = 0.83; 95% CI -3.8, 3.6) compared to matched non-pharmacy-desert tracts. Our secondary analysis indicated that low-access tracts had 2.4 fewer vaccinations per 1000 population (<em>p</em> = 0.004, 95% CI: −3.9, −0.7).</div></div><div><h3>Conclusions</h3><div>Low pharmacy access is associated with lower rates of shingles vaccination. The definition of pharmacy desert that includes a low-income criterion may not add further precision in identifying areas with inadequate access to pharmacy-based vaccinations. Efforts at the state and national levels to prevent pharmacy closures and support pharmacists in delivering care may improve access to important pharmacy services such as vaccination.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128256"},"PeriodicalIF":4.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146079700","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 : 2026-01-30DOI: 10.1016/j.vaccine.2026.128285
Karan Thakkar , Rengina Kefalogianni , Jessie Zhang , Chee Fu Yung , Shephali Tagore , Pradip Dashraath , Amy W. Law , Diana Mendes
Background
Respiratory syncytial virus (RSV) is a leading cause of respiratory tract infections in children. A novel bivalent RSV prefusion F protein subunit (RSVpreF) vaccine has recently been approved by the Health Sciences Authority (HSA) in Singapore. This study estimated the clinical and economic impact of a year-round RSVpreF maternal vaccination program on the prevention of RSV among infants in Singapore.
Methods
A Markov cohort model was used to project clinical and economic outcomes of RSV from birth to one year of age for RSVpreF vaccine compared to no intervention. Analyses were conducted from the healthcare system perspective, with direct costs (2025 Singapore dollars [S$]) and outcomes discounted at 3% annually; scenario and sensitivity analyses tested the robustness of the model. Findings: Compared to no intervention, a year-round RSVpreF program with 80% coverage would prevent 308 hospitalizations and 1995 outpatient visits annually, averting S$2.15 million in direct medical costs and saving 29 quality-adjusted life years (QALYs). The RSVpreF vaccine would be cost-effective up to S$237.68/dose under a cost-effectiveness threshold of 1 x gross domestic product per capita (S$121,378) per QALY gained.
Interpretation
Year-round RSVpreF maternal vaccination would help reduce pressures on the healthcare system as well as reduce RSV's clinical and economic burden among infants in Singapore, and likely be a cost-effective program.
{"title":"Clinical and economic benefits of bivalent respiratory syncytial virus prefusion F (RSVpreF) maternal vaccine for prevention of RSV illness in infants: A cost-effectiveness analysis for Singapore","authors":"Karan Thakkar , Rengina Kefalogianni , Jessie Zhang , Chee Fu Yung , Shephali Tagore , Pradip Dashraath , Amy W. Law , Diana Mendes","doi":"10.1016/j.vaccine.2026.128285","DOIUrl":"10.1016/j.vaccine.2026.128285","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory syncytial virus (RSV) is a leading cause of respiratory tract infections in children. A novel bivalent RSV prefusion F protein subunit (RSVpreF) vaccine has recently been approved by the Health Sciences Authority (HSA) in Singapore. This study estimated the clinical and economic impact of a year-round RSVpreF maternal vaccination program on the prevention of RSV among infants in Singapore.</div></div><div><h3>Methods</h3><div>A Markov cohort model was used to project clinical and economic outcomes of RSV from birth to one year of age for RSVpreF vaccine compared to no intervention. Analyses were conducted from the healthcare system perspective, with direct costs (2025 Singapore dollars [S$]) and outcomes discounted at 3% annually; scenario and sensitivity analyses tested the robustness of the model. Findings: Compared to no intervention, a year-round RSVpreF program with 80% coverage would prevent 308 hospitalizations and 1995 outpatient visits annually, averting S$2.15 million in direct medical costs and saving 29 quality-adjusted life years (QALYs). The RSVpreF vaccine would be cost-effective up to S$237.68/dose under a cost-effectiveness threshold of 1 x gross domestic product per capita (S$121,378) per QALY gained.</div></div><div><h3>Interpretation</h3><div>Year-round RSVpreF maternal vaccination would help reduce pressures on the healthcare system as well as reduce RSV's clinical and economic burden among infants in Singapore, and likely be a cost-effective program.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128285"},"PeriodicalIF":4.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146079794","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 : 2026-01-29DOI: 10.1016/j.vaccine.2026.128231
Monica E. Embers , Nicole R. Hasenkampf , Amanda C. Tardo , Yekaterina Timofeyeva , Sabine Wellnitz , Yan Li , Alexey Gribenko , Jeong-Jin Park , Alexandre Esadze , Sirena Tran , Jun Sun , Jill Dane , Donna Giordano-Schmidt , Guy Singh , Michelle Gaylord , Danielle Baranova , Andreas Meinke , Urban Lundberg , Romana Hochreiter , Sandra Jost , Raphael Simon
Lyme disease is a growing public health concern that is geographically focused in regions where ticks that carry the causative bacteria, Borrelia burgdorferi sensu lato (s.l.), are endemic. Outer surface protein A (OspA) is expressed by B. burgdorferi s.l. spirochetes during the tick phase and OspA antibodies introduced during tick feeding can block transmission and prevent B. burgdorferi infection. Candidate Lyme disease vaccine VLA15 is comprised of the C-terminal domains of the six B. burgdorferi s.l. OspA serotypes (ST) prevalent in North America and Europe. We report herein that non-human primates immunized with VLA15 were protected against challenge with Ixodes scapularis ticks bearing B. burgdorferi sensu stricto (s.s.) (OspA ST1). Levels of residual B. burgdorferi s.s. tick colonization were reduced in ticks that fed on VLA15-immunized primates compared to those immunized with full length-OspA ST1 (FL-OspA) at a point when OspA-binding IgG levels were similar. Furthermore, monoclonal antibodies targeting the C-terminal half of OspA, elicited by FL-OspA immunization in primates, were more effective at complement-mediated bactericidal killing in vitro and clearance of spirochetes in ticks versus those directed against other parts of the protein.
{"title":"Protective properties of a candidate C-terminal domain OspA vaccine for prevention of Lyme disease","authors":"Monica E. Embers , Nicole R. Hasenkampf , Amanda C. Tardo , Yekaterina Timofeyeva , Sabine Wellnitz , Yan Li , Alexey Gribenko , Jeong-Jin Park , Alexandre Esadze , Sirena Tran , Jun Sun , Jill Dane , Donna Giordano-Schmidt , Guy Singh , Michelle Gaylord , Danielle Baranova , Andreas Meinke , Urban Lundberg , Romana Hochreiter , Sandra Jost , Raphael Simon","doi":"10.1016/j.vaccine.2026.128231","DOIUrl":"10.1016/j.vaccine.2026.128231","url":null,"abstract":"<div><div>Lyme disease is a growing public health concern that is geographically focused in regions where ticks that carry the causative bacteria, <em>Borrelia burgdorferi</em> sensu lato (s.l.), are endemic. Outer surface protein A (OspA) is expressed by <em>B. burgdorferi</em> s.l. spirochetes during the tick phase and OspA antibodies introduced during tick feeding can block transmission and prevent <em>B. burgdorferi</em> infection. Candidate Lyme disease vaccine VLA15 is comprised of the C-terminal domains of the six <em>B. burgdorferi</em> s.l. OspA serotypes (ST) prevalent in North America and Europe. We report herein that non-human primates immunized with VLA15 were protected against challenge with <em>Ixodes scapularis</em> ticks bearing <em>B. burgdorferi</em> sensu stricto (s.s.) (OspA ST1). Levels of residual <em>B. burgdorferi</em> s.s. tick colonization were reduced in ticks that fed on VLA15-immunized primates compared to those immunized with full length-OspA ST1 (FL-OspA) at a point when OspA-binding IgG levels were similar. Furthermore, monoclonal antibodies targeting the C-terminal half of OspA, elicited by FL-OspA immunization in primates, were more effective at complement-mediated bactericidal killing <em>in vitro</em> and clearance of spirochetes in ticks versus those directed against other parts of the protein.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128231"},"PeriodicalIF":4.5,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146079699","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 : 2026-01-29DOI: 10.1016/j.vaccine.2026.128270
Mejbah Uddin Bhuiyan , Gustavo Hernandez-Suarez , Tamara Pilishvili , Ben Mayer , Victoria Abbing-Karahagopian
Background
This systematic literature review (SLR) evaluated the incidence and bacterial etiology of acute otitis media (AOM) in children.
Methods
Epidemiological studies in English reporting on AOM incidence (published 2008–2023) or the distribution of Streptococcus pneumoniae (Spn) including serotypes, Haemophilus influenzae (Hi), and Moraxella catarrhalis (Mcat) in children (<18 years) with AOM (published 2010–2023) were identified from Embase, MEDLINE, LILACS, and SciELO databases. Random-effect models were used to determine the pooled AOM incidence rates (IR), pooled prevalence of each bacterium and individual serotypes/strains, and the corresponding 95% confidence intervals. When feasible, the estimates were stratified by age group, geographical location, and pneumococcal vaccination status. Heterogeneity was assessed by the I2 statistic.
Findings
The SLR identified 37 publications reporting on AOM incidence, of which 25 were included in the meta-analysis, and 34 publications reporting on prevalence of bacterial pathogens in middle ear fluid. AOM IRs (per 100 person-years) were 18.77 in ≤2-year-olds, 10.39 in >2 to ≤5-year-olds, and <3 in children aged >5 years. In ≤2-year-olds, AOM IR was 16.07 among those who received a pneumococcal conjugate vaccine (PCV) and 34.26 among those who did not. Among ≤2-year-olds, Hi contributed to 31.81% of AOM cases, followed by 19.35% for Spn, and 3.00% for Mcat. Across all ages, frequently reported Spn serotypes among Spn-AOM cases were 3 (10.81%), 19F (10.65%), 19A (10.43%), 23A (4.60%), 35B (4.38%), and 21 (3.23%) whereas 78.2% of Hi-AOM cases were caused by non-typeable Hi (NTHi).
Interpretation
A substantial AOM burden in children remains during the PCV era, with disproportionately higher incidence among children ≤2 years old. Select PCV- and non-PCV pneumococcal serotypes and NTHi have contributed significantly to the AOM burden. Vaccines offering improved protection against remaining PCV serotypes, emerging pneumococcal serotypes, and NTHi are needed to reduce the existing AOM burden in children.
{"title":"Incidence and bacterial etiology of acute otitis media in children in the pneumococcal conjugate vaccine era: A systematic literature review and meta-analysis","authors":"Mejbah Uddin Bhuiyan , Gustavo Hernandez-Suarez , Tamara Pilishvili , Ben Mayer , Victoria Abbing-Karahagopian","doi":"10.1016/j.vaccine.2026.128270","DOIUrl":"10.1016/j.vaccine.2026.128270","url":null,"abstract":"<div><h3>Background</h3><div>This systematic literature review (SLR) evaluated the incidence and bacterial etiology of acute otitis media (AOM) in children.</div></div><div><h3>Methods</h3><div>Epidemiological studies in English reporting on AOM incidence (published 2008–2023) or the distribution of <em>Streptococcus pneumoniae</em> (Spn) including serotypes, <em>Haemophilus influenzae</em> (Hi), and <em>Moraxella catarrhalis</em> (Mcat) in children (<18 years) with AOM (published 2010–2023) were identified from Embase, MEDLINE, LILACS, and SciELO databases. Random-effect models were used to determine the pooled AOM incidence rates (IR), pooled prevalence of each bacterium and individual serotypes/strains, and the corresponding 95% confidence intervals. When feasible, the estimates were stratified by age group, geographical location, and pneumococcal vaccination status. Heterogeneity was assessed by the <em>I</em><sup><em>2</em></sup> statistic.</div></div><div><h3>Findings</h3><div>The SLR identified 37 publications reporting on AOM incidence, of which 25 were included in the meta-analysis, and 34 publications reporting on prevalence of bacterial pathogens in middle ear fluid. AOM IRs (per 100 person-years) were 18.77 in ≤2-year-olds, 10.39 in >2 to ≤5-year-olds, and <3 in children aged >5 years. In ≤2-year-olds, AOM IR was 16.07 among those who received a pneumococcal conjugate vaccine (PCV) and 34.26 among those who did not. Among ≤2-year-olds, Hi contributed to 31.81% of AOM cases, followed by 19.35% for Spn, and 3.00% for Mcat. Across all ages, frequently reported Spn serotypes among Spn-AOM cases were 3 (10.81%), 19F (10.65%), 19A (10.43%), 23A (4.60%), 35B (4.38%), and 21 (3.23%) whereas 78.2% of Hi-AOM cases were caused by non-typeable Hi (NTHi).</div></div><div><h3>Interpretation</h3><div>A substantial AOM burden in children remains during the PCV era, with disproportionately higher incidence among children ≤2 years old. Select PCV- and non-PCV pneumococcal serotypes and NTHi have contributed significantly to the AOM burden. Vaccines offering improved protection against remaining PCV serotypes, emerging pneumococcal serotypes, and NTHi are needed to reduce the existing AOM burden in children.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128270"},"PeriodicalIF":4.5,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146079792","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 : 2026-01-29DOI: 10.1016/j.vaccine.2026.128277
Lukui Cai , Yixian Fu , Jingyan Li , Xiaoyu Wang , Yan Ma , Qin Gu , Qiuyan Ji , Guoyang Liao , Shengjie Ouyang , Hongbo Chen , Lujie Yang , Mingqing Wang , Wenzhu Hu , Hongwei Liao , Guang Ji , Jiana Wen , Na Gao , Lin Ping , Yuting Fu , Han Chu , Jingsi Yang
The DTacP-sIPV/Hib combination vaccine is designed to replace the separate administration of diphtheria, tetanus, acellular pertussis, poliomyelitis, and Haemophilus influenzae type b vaccines. By incorporating Sabin strain inactivated poliovirus, DTacP-sIPV/Hib offers advantages in biosafety and manufacturing cost. This study provides a preliminary evaluation of the preclinical safety of a novel DTacP-sIPV/Hib combination vaccine in three animal models.
Sprague-Dawley rats were randomly assigned to receive either DTacP-sIPV/Hib or saline by intramuscular injection and were monitored for 14 days for local reactions, body weight, and food intake, followed by necropsy and histopathological examination. Guinea pigs were allocated to negative control, positive control or vaccine groups and sensitized by three intramuscular injections on alternate days; animals were subsequently challenged and observed for allergic reactions. Japanese white rabbits were used in a bilateral self-controlled design, receiving vaccine in one quadriceps and saline in the contralateral side, with macroscopic and histopathological evaluation at 48 h and 16 days post-injection.
The candidate DTacP-sIPV/Hib vaccine induced only mild, transient, and reversible local reactions in SD rats and rabbits, indicating acceptable local tolerability under the conditions tested. No detectable effects on body weight or food intake were observed in rats, and no allergic reactions were induced in guinea pigs, suggesting no apparent systemic safety signals in these models. Overall, these findings provide supportive nonclinical safety evidence for the candidate DTacP-sIPV/Hib vaccine and may inform the design and risk assessment of subsequent clinical studies.
{"title":"Preliminary safety evaluation of a diphtheria, tetanus, acellular component pertussis, Sabin inactivated poliovirus and Haemophilus influenzae type b combination vaccine (DTacP-sIPV/Hib)","authors":"Lukui Cai , Yixian Fu , Jingyan Li , Xiaoyu Wang , Yan Ma , Qin Gu , Qiuyan Ji , Guoyang Liao , Shengjie Ouyang , Hongbo Chen , Lujie Yang , Mingqing Wang , Wenzhu Hu , Hongwei Liao , Guang Ji , Jiana Wen , Na Gao , Lin Ping , Yuting Fu , Han Chu , Jingsi Yang","doi":"10.1016/j.vaccine.2026.128277","DOIUrl":"10.1016/j.vaccine.2026.128277","url":null,"abstract":"<div><div>The DTacP-sIPV/Hib combination vaccine is designed to replace the separate administration of diphtheria, tetanus, acellular pertussis, poliomyelitis, and <em>Haemophilus influenzae</em> type b vaccines. By incorporating Sabin strain inactivated poliovirus, DTacP-sIPV/Hib offers advantages in biosafety and manufacturing cost. This study provides a preliminary evaluation of the preclinical safety of a novel DTacP-sIPV/Hib combination vaccine in three animal models.</div><div>Sprague-Dawley rats were randomly assigned to receive either DTacP-sIPV/Hib or saline by intramuscular injection and were monitored for 14 days for local reactions, body weight, and food intake, followed by necropsy and histopathological examination. Guinea pigs were allocated to negative control, positive control or vaccine groups and sensitized by three intramuscular injections on alternate days; animals were subsequently challenged and observed for allergic reactions. Japanese white rabbits were used in a bilateral self-controlled design, receiving vaccine in one quadriceps and saline in the contralateral side, with macroscopic and histopathological evaluation at 48 h and 16 days post-injection.</div><div>The candidate DTacP-sIPV/Hib vaccine induced only mild, transient, and reversible local reactions in SD rats and rabbits, indicating acceptable local tolerability under the conditions tested. No detectable effects on body weight or food intake were observed in rats, and no allergic reactions were induced in guinea pigs, suggesting no apparent systemic safety signals in these models. Overall, these findings provide supportive nonclinical safety evidence for the candidate DTacP-sIPV/Hib vaccine and may inform the design and risk assessment of subsequent clinical studies.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128277"},"PeriodicalIF":4.5,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146079747","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 : 2026-01-29DOI: 10.1016/j.vaccine.2026.128245
Ziyi Liao , Meilin Wu , Yuan Chen , Zifan Zhu , Yuhang Li , Qijun Mei , Bo Huang , Xin Cheng , Yi Zhang , Hao Zeng , Daiyuan Ma , Jiang Gu
Staphylococcus aureus (SA) causes severe hospital-and community-acquired infections, yet no vaccine is licensed. Staphylococcal enterotoxin B (SEB) is a conserved virulence factor and a key target for vaccine development. However, SEB protein subunit vaccines often suffer from limited immunogenicity. Self-assembling mi3 nanoparticles provide an efficient antigen display platform and could overcome subunit limitations. We engineered a nanoparticle vaccine by displaying detoxified mutant SEB (L45R, Y89A, Y94A) on mi3 scaffold (mSEB-mi3). Biophysical characterization confirmed stable, uniform particles with efficient antigen conjugation. We compared adjuvants (ALPO4, CpG ODN1018, AS01, MF59) in mice, assessing dendritic cell (DC) uptake/maturation, humoral responses, and protection against in SEB intoxication and methicillin-resistant SA (MRSA) ST59 infection models, alongside safety evaluations. We successfully produced a uniform and stable mSEB-mi3 nanoparticle. The mSEB-mi3 markedly improves dendritic-cell uptake and maturation and drives rapid, high, and durable antibody responses with balanced IgG1/IgG2a isotypes. Functionally, a single intramuscular dose confers strong protection against both SEB intoxication and SA ST59 challenge. In addition, safety profiles were acceptable across hematology, chemistry, cytotoxicity, and histopathology. These results identify mSEB-mi3 as a promising and scalable nanoparticle vaccine against SA and SEB toxin. The findings support further studies of durability, strain breadth, and translational development.
{"title":"Single-dose mSEB–mi3 nanoparticle vaccine elicits robust humoral immunity and protects mice against SEB intoxication and MRSA infection","authors":"Ziyi Liao , Meilin Wu , Yuan Chen , Zifan Zhu , Yuhang Li , Qijun Mei , Bo Huang , Xin Cheng , Yi Zhang , Hao Zeng , Daiyuan Ma , Jiang Gu","doi":"10.1016/j.vaccine.2026.128245","DOIUrl":"10.1016/j.vaccine.2026.128245","url":null,"abstract":"<div><div><em>Staphylococcus aureus</em> (SA) causes severe hospital-and community-acquired infections, yet no vaccine is licensed. Staphylococcal enterotoxin B (SEB) is a conserved virulence factor and a key target for vaccine development. However, SEB protein subunit vaccines often suffer from limited immunogenicity. Self-assembling mi3 nanoparticles provide an efficient antigen display platform and could overcome subunit limitations. We engineered a nanoparticle vaccine by displaying detoxified mutant SEB (L45R, Y89A, Y94A) on mi3 scaffold (mSEB-mi3). Biophysical characterization confirmed stable, uniform particles with efficient antigen conjugation. We compared adjuvants (ALPO4, CpG ODN1018, AS01, MF59) in mice, assessing dendritic cell (DC) uptake/maturation, humoral responses, and protection against in SEB intoxication and methicillin-resistant SA (MRSA) ST59 infection models, alongside safety evaluations. We successfully produced a uniform and stable mSEB-mi3 nanoparticle. The mSEB-mi3 markedly improves dendritic-cell uptake and maturation and drives rapid, high, and durable antibody responses with balanced IgG1/IgG2a isotypes. Functionally, a single intramuscular dose confers strong protection against both SEB intoxication and SA ST59 challenge. In addition, safety profiles were acceptable across hematology, chemistry, cytotoxicity, and histopathology. These results identify mSEB-mi3 as a promising and scalable nanoparticle vaccine against SA and SEB toxin. The findings support further studies of durability, strain breadth, and translational development.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128245"},"PeriodicalIF":4.5,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146079789","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}
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