Pub Date : 2025-12-01Epub Date: 2025-09-19DOI: 10.1016/j.jvacx.2025.100732
Wenming Wei , Chongyang Wu , Xi Wang , Xinyue Cui , Yuanzi Huo , Xinyu Li , Yuexia Liang , Bo Ma , Shuyuan Pan , Song Gao
Pertussis toxin (PTx) is a key virulence factor of the organism Bordetella pertussis, which must undergo proper detoxification as a component of acellular pertussis vaccines. Chemical detoxification using glutaraldehyde causes significant changes to the toxin surface, reducing its toxicity and potentially affecting its antigen properties. Although previous studies have thoroughly investigated the toxicity of chemically detoxified PT toxoid (PTd), there is limited understanding regarding how detoxification influences its antigenic properties and immunogenicity. Moreover, the specific parameters—such as glutaraldehyde concentration and buffer pH—and their effects on toxicity and immunogenicity are poorly defined. This study began by examining the influence of these parameters on the structural profiles of PTd. Subsequently, the toxicity and antigenic properties of PTd were characterized in vitro. Next, neutralizing epitopes remaining on PTd were quantified to assess the antigenicity. Finally, the immunogenicity of acellular pertussis vaccine candidates containing PTd was further evaluated in vivo. We found that the glutaraldehyde treatment caused more dramatic structural changes in B oligomer than A protomer of PTx, independent of variance in glutaraldehyde concentration and buffer pH. As a result, residual toxicity was reduced, and antigenic properties were altered. Following this, changes in antigenic properties were proved to be related to compromised immunogenicity. This study demonstrates that glutaraldehyde modulates the two functional domains of PTx, affecting both its toxicity and immunogenicity; two factors-glutaraldehyde concentration and buffer pH reduce the biochemical activities by bias influencing A protomer and B-oligomer. This work also underscores the importance of maintaining a delicate balance between immunogenicity and toxicity in detoxification.
{"title":"Glutaraldehyde modifies the catalytic and binding subunits of pertussis toxin, affecting its toxicity and immunogenicity","authors":"Wenming Wei , Chongyang Wu , Xi Wang , Xinyue Cui , Yuanzi Huo , Xinyu Li , Yuexia Liang , Bo Ma , Shuyuan Pan , Song Gao","doi":"10.1016/j.jvacx.2025.100732","DOIUrl":"10.1016/j.jvacx.2025.100732","url":null,"abstract":"<div><div>Pertussis toxin (PTx) is a key virulence factor of the organism <em>Bordetella pertussis</em>, which must undergo proper detoxification as a component of acellular pertussis vaccines. Chemical detoxification using glutaraldehyde causes significant changes to the toxin surface, reducing its toxicity and potentially affecting its antigen properties. Although previous studies have thoroughly investigated the toxicity of chemically detoxified PT toxoid (PTd), there is limited understanding regarding how detoxification influences its antigenic properties and immunogenicity. Moreover, the specific parameters—such as glutaraldehyde concentration and buffer pH—and their effects on toxicity and immunogenicity are poorly defined. This study began by examining the influence of these parameters on the structural profiles of PTd. Subsequently, the toxicity and antigenic properties of PTd were characterized in vitro. Next, neutralizing epitopes remaining on PTd were quantified to assess the antigenicity. Finally, the immunogenicity of acellular pertussis vaccine candidates containing PTd was further evaluated in vivo. We found that the glutaraldehyde treatment caused more dramatic structural changes in B oligomer than A protomer of PTx, independent of variance in glutaraldehyde concentration and buffer pH. As a result, residual toxicity was reduced, and antigenic properties were altered. Following this, changes in antigenic properties were proved to be related to compromised immunogenicity. This study demonstrates that glutaraldehyde modulates the two functional domains of PTx, affecting both its toxicity and immunogenicity; two factors-glutaraldehyde concentration and buffer pH reduce the biochemical activities by bias influencing A protomer and B-oligomer. This work also underscores the importance of maintaining a delicate balance between immunogenicity and toxicity in detoxification.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100732"},"PeriodicalIF":2.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145118943","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}
Pub Date : 2025-12-01Epub Date: 2025-10-28DOI: 10.1016/j.jvacx.2025.100742
Maria Lahuerta , Angel Gil , Cristina Méndez , Francisco Javier Esteban Fernández , Teresa Álvarez de Espejo , Victor Julián Moreno , Pablo del Valle , Juan E. Losa , José Yuste , Julie Catusse , Mohammad Ali , Jo Southern , Elizabeth Begier , Michael Pride , Christian Theilacker , Luis Jodar , Bradford D. Gessner , Mariana Haeberer , on behalf of the CIBELES study team
Background
Few data exist on vaccine effectiveness (VE) of the 13-valent pneumococcal conjugate vaccine (PCV13) against vaccine-type community acquired pneumonia (CAP) among adults, particularly for multiple years post-vaccination. We evaluated PCV13 VE among older adults in Spain right after the emergence of SARS-CoV2.
Methods
Adults aged ≥60 years hospitalized with CAP were enrolled at five hospitals between March 2021–September 2023. VE was assessed using a test-negative design. Cases were participants from whom PCV13 serotypes were identified from culture or urinary antigen detection assays. All others served as controls. Due to changes in healthcare-seeking behavior, hospital admission, vaccination policies, and CAP etiology during the COVID pandemic period, participants enrolled from March 2021–August 2022 were excluded from analyses.
Results
Among 1512 eligible participants, 1241 (82.1 %) were included in the analysis. Median age was 78 years (interquartile range [IQR] 72–85), 34.3 % were immunocompromised and 99.4 % had radiologically-confirmed CAP. Almost half (49.2 %) had received PCV13 of which 33.1 % were vaccinated in 2020 during the COVID-19 pandemic (median time since vaccination: 2.0 years [IQR:2.0–4.2]). Most participants (72.7 %) had previously received the pneumococcal polysaccharide vaccine (PPV23). PCV13 serotypes were identified in 89 (7.2 %) participants, most commonly serotype 3 (56 cases, 62.9 % of PCV13-type CAP). The PCV13 VE against PCV13-type CAP was 26.0 % (−15.21, 52.4 %) overall, 40.9 % (−23.1, 71.6 %) excluding serotype 3 and 51.9 % (−26.0, 81.6 %) among PPV23-naive. Among patients vaccinated <2 years before CAP hospitalization, VE against PCV13-type was 68.9 % (11.9, 89.0 %).
Conclusions
In a setting with high serotype 3 prevalence, PCV13 was highly effective in preventing PCV13-type CAP in older adults for two years after vaccination, with lower effectiveness at later time points. Given challenges associated with the pandemic and low statistical power, additional studies are indicated to evaluate serotype-specific duration of protection to inform the need for adult booster vaccinations.
{"title":"Effectiveness of the 13-valent pneumococcal vaccine against hospitalized community-acquired pneumonia among adults ≥60 years in Madrid-Spain after the COVID-19 pandemic","authors":"Maria Lahuerta , Angel Gil , Cristina Méndez , Francisco Javier Esteban Fernández , Teresa Álvarez de Espejo , Victor Julián Moreno , Pablo del Valle , Juan E. Losa , José Yuste , Julie Catusse , Mohammad Ali , Jo Southern , Elizabeth Begier , Michael Pride , Christian Theilacker , Luis Jodar , Bradford D. Gessner , Mariana Haeberer , on behalf of the CIBELES study team","doi":"10.1016/j.jvacx.2025.100742","DOIUrl":"10.1016/j.jvacx.2025.100742","url":null,"abstract":"<div><h3>Background</h3><div>Few data exist on vaccine effectiveness (VE) of the 13-valent pneumococcal conjugate vaccine (PCV13) against vaccine-type community acquired pneumonia (CAP) among adults, particularly for multiple years post-vaccination. We evaluated PCV13 VE among older adults in Spain right after the emergence of SARS-CoV2.</div></div><div><h3>Methods</h3><div>Adults aged ≥60 years hospitalized with CAP were enrolled at five hospitals between March 2021–September 2023. VE was assessed using a test-negative design. Cases were participants from whom PCV13 serotypes were identified from culture or urinary antigen detection assays. All others served as controls. Due to changes in healthcare-seeking behavior, hospital admission, vaccination policies, and CAP etiology during the COVID pandemic period, participants enrolled from March 2021–August 2022 were excluded from analyses.</div></div><div><h3>Results</h3><div>Among 1512 eligible participants, 1241 (82.1 %) were included in the analysis. Median age was 78 years (interquartile range [IQR] 72–85), 34.3 % were immunocompromised and 99.4 % had radiologically-confirmed CAP. Almost half (49.2 %) had received PCV13 of which 33.1 % were vaccinated in 2020 during the COVID-19 pandemic (median time since vaccination: 2.0 years [IQR:2.0–4.2]). Most participants (72.7 %) had previously received the pneumococcal polysaccharide vaccine (PPV23). PCV13 serotypes were identified in 89 (7.2 %) participants, most commonly serotype 3 (56 cases, 62.9 % of PCV13-type CAP). The PCV13 VE against PCV13-type CAP was 26.0 % (−15.21, 52.4 %) overall, 40.9 % (−23.1, 71.6 %) excluding serotype 3 and 51.9 % (−26.0, 81.6 %) among PPV23-naive. Among patients vaccinated <2 years before CAP hospitalization, VE against PCV13-type was 68.9 % (11.9, 89.0 %).</div></div><div><h3>Conclusions</h3><div>In a setting with high serotype 3 prevalence, PCV13 was highly effective in preventing PCV13-type CAP in older adults for two years after vaccination, with lower effectiveness at later time points. Given challenges associated with the pandemic and low statistical power, additional studies are indicated to evaluate serotype-specific duration of protection to inform the need for adult booster vaccinations.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100742"},"PeriodicalIF":2.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145417289","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}
Dengue vaccine Qdenga® has been available in Argentina since November 2023. This study aimed to evaluate adverse events following immunization (AEFI) in individuals vaccinated with Qdenga® in private centers in the metropolitan area of Buenos Aires.
Methods
A retrospective, observational, multicenter study was conducted through passive surveillance of AEFI in individuals ≥4-years-old who received Qdenga® from 01/Nov/2023 to 01/Nov/2024.
AEFI incidence was calculated per 1000 doses administered, stratified by dose, age group and seriousness. Associations between population characteristics and AEFI were analysed. Hypersensitivity reactions incidence was calculated.
Results
156,676 doses were administered to 112,345 individuals, mean age 36.5 years (median 40; range 4–102).
A total of 303 AEFI were reported, with an incidence rate of 1.9/1000; 2.5/1000 (277/109,281) for first dose and 0.5/1000 (26/47,395) for second dose. No statistical differences by age and higher reports in 18–60-year-old group women were observed.
AEFI classification
1-Non-serious (95.1%): the most frequent were rash (41.8%), myalgia (30.0%), pyrexia (29.2%) and headache (26.0%) after first dose; pyrexia (38.5%) and headache (26.9%) after second dose. 2-Serious (1.3%): anaphylactic reaction, nephrotic syndrome, immune thrombocytopenic purpura, and Hodgkin's lymphoma. 3-Special Situation Reports (2.6%): Five pregnant women vaccinated; one infant born with interventricular communication. Three vaccinated while breastfeeding; one infant had diarrhea. 4-Vaccine administration errors (1.0%): three cases.
Anaphylaxis and hypersensitivity non-anaphylaxis incidence: 0.006/1000 and 0.14/1000 respectively.
Conclusion
AEFI cases were more common after the first dose and mostly non-serious. No age-related association was found. This study identified few signals in passive surveillance after Qdenga® vaccine.
{"title":"Retrospective analysis of one year of passive safety surveillance data following implementation of the dengue vaccine, Qdenga® (TAK-003) at private vaccination centers, in Buenos Aires, Argentina","authors":"Vanesa Edelvais Castellano MD , Sofìa Diana Menéndez , Jimena Ochoa MD , Fernando Burgos MD , Fernando Fernadez MD , Romina Gigliotti MD , Mariano Díaz MD , Pablo Bonvehí MD","doi":"10.1016/j.jvacx.2025.100749","DOIUrl":"10.1016/j.jvacx.2025.100749","url":null,"abstract":"<div><h3>Background</h3><div>Dengue vaccine Qdenga® has been available in Argentina since November 2023. This study aimed to evaluate adverse events following immunization (AEFI) in individuals vaccinated with Qdenga® in private centers in the metropolitan area of Buenos Aires.</div></div><div><h3>Methods</h3><div>A retrospective, observational, multicenter study was conducted through passive surveillance of AEFI in individuals ≥4-years-old who received Qdenga® from 01/Nov/2023 to 01/Nov/2024.</div><div>AEFI incidence was calculated per 1000 doses administered, stratified by dose, age group and seriousness. Associations between population characteristics and AEFI were analysed. Hypersensitivity reactions incidence was calculated.</div></div><div><h3>Results</h3><div>156,676 doses were administered to 112,345 individuals, mean age 36.5 years (median 40; range 4–102).</div><div>A total of 303 AEFI were reported, with an incidence rate of 1.9/1000; 2.5/1000 (277/109,281) for first dose and 0.5/1000 (26/47,395) for second dose. No statistical differences by age and higher reports in 18–60-year-old group women were observed.</div></div><div><h3>AEFI classification</h3><div>1-Non-serious (95.1%): the most frequent were rash (41.8%), myalgia (30.0%), pyrexia (29.2%) and headache (26.0%) after first dose; pyrexia (38.5%) and headache (26.9%) after second dose. 2-Serious (1.3%): anaphylactic reaction, nephrotic syndrome, immune thrombocytopenic purpura, and Hodgkin's lymphoma. 3-Special Situation Reports (2.6%): Five pregnant women vaccinated; one infant born with interventricular communication. Three vaccinated while breastfeeding; one infant had diarrhea. 4-Vaccine administration errors (1.0%): three cases.</div><div>Anaphylaxis and hypersensitivity non-anaphylaxis incidence: 0.006/1000 and 0.14/1000 respectively.</div></div><div><h3>Conclusion</h3><div>AEFI cases were more common after the first dose and mostly non-serious. No age-related association was found. This study identified few signals in passive surveillance after Qdenga® vaccine.</div><div><strong>Clinical trial registration number:</strong> <span><span>NCT06898775</span><svg><path></path></svg></span></div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100749"},"PeriodicalIF":2.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145525340","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}
Pub Date : 2025-12-01Epub Date: 2025-09-08DOI: 10.1016/j.jvacx.2025.100718
Lin Yao , Xiao-Lin Jiang , Jun-Xia Cao , Qiang Guo , Meng-Na Wu , Shu-Zhi Wu , Li-Jun Duan , Yuan Shen , Bing-Dong Zhan , Jun-Fen Lin , Ming-Dong Jiang , Hong-Hong Peng , Yu-Wei Zhang , Guo-Jian Yang , Xue-Dong Song , Chao Shi , Ji-Yan Zhang , Wen-Guo Jiang , Mai-Juan Ma
Determining the durability of immunity after SARS-CoV-2 infection or vaccination is critical for understanding immune protection upon reinfection and optimizing vaccine design. We measured SARS-CoV-2-specific antibodies and T-cell responses in COVID-19 convalescent patients up to 14 months after infection and COVID-19 convalescents who received two doses of BBIBP-CorV at 6-month intervals. We observed that most convalescents had durable neutralizing antibody and T-cell responses against the SARS-CoV-2 Wuhan strain at least 14 months after infection. Administering a booster dose to convalescent patients significantly increased neutralizing antibodies against the Wuhan strain, but neutralization activity against Omicron BA.1, BA.2, BA.2.12.1, and BA.4/BA.5 was significantly decreased. Six months after the first dose vaccination, the neutralizing antibody levels significantly declined and were not further enhanced by a second dose. Omicron BA.1-specific T-cell responses were detectable in most convalescent patients and were not significantly affected by vaccination. These analyses provide insights into the durability of the immune response after infection and hybrid immunization and may be relevant for future vaccine strategies.
确定SARS-CoV-2感染或疫苗接种后免疫的持久性对于了解再感染后的免疫保护和优化疫苗设计至关重要。我们测量了感染后14个月的COVID-19恢复期患者和每隔6个月接受两剂BBIBP-CorV的COVID-19恢复期患者的sars - cov -2特异性抗体和t细胞反应。我们观察到，大多数康复者在感染后至少14个月对SARS-CoV-2武汉株有持久的中和抗体和t细胞反应。恢复期患者给予加强剂量后，抗武汉株的中和抗体显著增加，但抗欧米克隆ba1 .1、ba2 .2、ba2.12.1和ba4 /BA的中和活性明显增加。5显著降低。第一剂疫苗接种后6个月，中和抗体水平显著下降，第二剂疫苗接种后未进一步增强。在大多数恢复期患者中可检测到Omicron ba .1特异性t细胞反应，并且接种疫苗不显著影响。这些分析为感染和混合免疫后免疫反应的持久性提供了见解，并可能与未来的疫苗策略相关。
{"title":"Durability of neutralizing antibody and T-cell responses in COVID-19 patients after infection and booster vaccination","authors":"Lin Yao , Xiao-Lin Jiang , Jun-Xia Cao , Qiang Guo , Meng-Na Wu , Shu-Zhi Wu , Li-Jun Duan , Yuan Shen , Bing-Dong Zhan , Jun-Fen Lin , Ming-Dong Jiang , Hong-Hong Peng , Yu-Wei Zhang , Guo-Jian Yang , Xue-Dong Song , Chao Shi , Ji-Yan Zhang , Wen-Guo Jiang , Mai-Juan Ma","doi":"10.1016/j.jvacx.2025.100718","DOIUrl":"10.1016/j.jvacx.2025.100718","url":null,"abstract":"<div><div>Determining the durability of immunity after SARS-CoV-2 infection or vaccination is critical for understanding immune protection upon reinfection and optimizing vaccine design. We measured SARS-CoV-2-specific antibodies and T-cell responses in COVID-19 convalescent patients up to 14 months after infection and COVID-19 convalescents who received two doses of BBIBP-CorV at 6-month intervals. We observed that most convalescents had durable neutralizing antibody and T-cell responses against the SARS-CoV-2 Wuhan strain at least 14 months after infection. Administering a booster dose to convalescent patients significantly increased neutralizing antibodies against the Wuhan strain, but neutralization activity against Omicron BA.1, BA.2, BA.2.12.1, and BA.4/BA.5 was significantly decreased. Six months after the first dose vaccination, the neutralizing antibody levels significantly declined and were not further enhanced by a second dose. Omicron BA.1-specific T-cell responses were detectable in most convalescent patients and were not significantly affected by vaccination. These analyses provide insights into the durability of the immune response after infection and hybrid immunization and may be relevant for future vaccine strategies.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100718"},"PeriodicalIF":2.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145107624","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}
Pub Date : 2025-12-01Epub Date: 2025-11-26DOI: 10.1016/j.jvacx.2025.100758
Antonio Musolino , Marco Roversi , Mariateresa Romaniello , Vittorio Scoppola , Chiara Di Camillo , Laura Celestini , Alberto Villani , Diletta Valentini
{"title":"Corrigendum to “Antibody response after pneumococcal vaccination in a large cohort of Italian children and adolescents with Down syndrome” [Vaccine: X 27 (2025) 100744]","authors":"Antonio Musolino , Marco Roversi , Mariateresa Romaniello , Vittorio Scoppola , Chiara Di Camillo , Laura Celestini , Alberto Villani , Diletta Valentini","doi":"10.1016/j.jvacx.2025.100758","DOIUrl":"10.1016/j.jvacx.2025.100758","url":null,"abstract":"","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100758"},"PeriodicalIF":2.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145690361","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}
Pub Date : 2025-12-01Epub Date: 2025-10-15DOI: 10.1016/j.jvacx.2025.100738
Giovanni Genovese , Elisabetta Genovese , Domenico Santoro , Flavia Pennisi , Giuseppe Trimarchi , Raffaele Squeri , Daniela Lo Giudice , Cristina Genovese
Background
Chronic kidney disease is (CKD) a highly prevalent condition worldwide, with an increasing prevalence in the general population. Effective vaccination strategies are crucial in this population to prevent hepatitis B virus (HBV)-related complications. This study aimed to evaluate the effectiveness of different HBV vaccines in patients with CKD undergoing dialysis, focusing on seroconversion rates and overall immune response.
Methods
A non-concurrent prospective cohort study was conducted on 160 outpatient long-term dialysis patients at the G. Martino Hospital in Messina. Patients were vaccinated with either FENDRIX (HB-AS04), HBVAXPRO 40 mg, or a combination, and their immune responses were assessed one month after the completion of the vaccination course.
Results
The study achieved 100 % vaccination coverage. The overall seroconversion rate was 62.5 %, with mean anti-HBs titers of 604.15 mIU/mL (±437.23 SD) across the cohorts. No significant differences were observed between responders and non-responders concerning demographic, clinical, and biochemical characteristics.
Conclusion
The study confirms the effectiveness of HBV vaccines in patients with CKD, though with a lower and delayed response compared to the general population. Establishing a diagnostic-therapeutic care pathway that integrates vaccination from the early stages of CKD is essential to improve outcomes in this high-risk group.
{"title":"Real-world effectiveness of hepatitis B vaccination in dialysis patients","authors":"Giovanni Genovese , Elisabetta Genovese , Domenico Santoro , Flavia Pennisi , Giuseppe Trimarchi , Raffaele Squeri , Daniela Lo Giudice , Cristina Genovese","doi":"10.1016/j.jvacx.2025.100738","DOIUrl":"10.1016/j.jvacx.2025.100738","url":null,"abstract":"<div><h3>Background</h3><div>Chronic kidney disease is (CKD) a highly prevalent condition worldwide, with an increasing prevalence in the general population. Effective vaccination strategies are crucial in this population to prevent hepatitis B virus (HBV)-related complications. This study aimed to evaluate the effectiveness of different HBV vaccines in patients with CKD undergoing dialysis, focusing on seroconversion rates and overall immune response.</div></div><div><h3>Methods</h3><div>A non-concurrent prospective cohort study was conducted on 160 outpatient long-term dialysis patients at the G. Martino Hospital in Messina. Patients were vaccinated with either FENDRIX (HB-AS04), HBVAXPRO 40 mg, or a combination, and their immune responses were assessed one month after the completion of the vaccination course.</div></div><div><h3>Results</h3><div>The study achieved 100 % vaccination coverage. The overall seroconversion rate was 62.5 %, with mean anti-HBs titers of 604.15 mIU/mL (±437.23 SD) across the cohorts. No significant differences were observed between responders and non-responders concerning demographic, clinical, and biochemical characteristics.</div></div><div><h3>Conclusion</h3><div>The study confirms the effectiveness of HBV vaccines in patients with CKD, though with a lower and delayed response compared to the general population. Establishing a diagnostic-therapeutic care pathway that integrates vaccination from the early stages of CKD is essential to improve outcomes in this high-risk group.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100738"},"PeriodicalIF":2.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145325792","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}
Pub Date : 2025-12-01Epub Date: 2025-11-07DOI: 10.1016/j.jvacx.2025.100747
Bente Smagge , Susan Hahné , Hester de Melker , Ferishta Bakhshi-Raiez , Susan van den Hof , Brechje de Gier
In the Netherlands, medical risk data and SARS-CoV-2 test results were not available for stratifying vaccine effectiveness (VE) against COVID-19 hospitalisation during the COVID-19 pandemic. Such data became available afterwards, allowing for re-estimating VE and the number needed to vaccinate (NNV) by medical risk group for severe COVID-19. We conducted a nationwide register-based cohort study, estimating VE against first-time COVID-19 hospitalisation from 06 to 01-2021 to 31-12-2021 in persons aged ≥12 years without registered prior SARS-CoV-2 infection. VE of one and two vaccinations, versus unvaccinated, were estimated by age, medical risk, vaccine type and time since vaccination using Cox models with vaccination status as time-varying exposure. Additionally, we computed the NNV to prevent one hospitalisation. Among 14.3 million individuals in this study, 43,405 COVID-19 first-time hospitalisations were recorded. VE of two doses was >80 % in the first quarter post-vaccination across all strata. VE decreased over time, but vaccination remained protective three quarters post-vaccination. Among persons aged ≥60 years without medical risk conditions, VE was 96.1 %, 91.0 % and 84.9 % in the first, second and third quarter since vaccination. VE was lower and waned faster among persons with medical risk conditions: 91.1 %, 80.0 %, 70.8 % and 85.4 %, 73.4 %, 60.6 %, in the first three quarters post-vaccination in the moderate and high medical risk groups, respectively. Nonetheless, the NNV was lower among medical risk groups. These findings suggest that prioritising medical risk populations for booster vaccination was warranted. To adequately respond to future epidemics and optimise vaccination programmes, the data infrastructure should allow near-real-time stratified VE analyses.
{"title":"COVID-19 vaccine effectiveness against hospitalisation in the Netherlands, 2021: Improved stratified estimates","authors":"Bente Smagge , Susan Hahné , Hester de Melker , Ferishta Bakhshi-Raiez , Susan van den Hof , Brechje de Gier","doi":"10.1016/j.jvacx.2025.100747","DOIUrl":"10.1016/j.jvacx.2025.100747","url":null,"abstract":"<div><div>In the Netherlands, medical risk data and SARS-CoV-2 test results were not available for stratifying vaccine effectiveness (VE) against COVID-19 hospitalisation during the COVID-19 pandemic. Such data became available afterwards, allowing for re-estimating VE and the number needed to vaccinate (NNV) by medical risk group for severe COVID-19. We conducted a nationwide register-based cohort study, estimating VE against first-time COVID-19 hospitalisation from 06 to 01-2021 to 31-12-2021 in persons aged ≥12 years without registered prior SARS-CoV-2 infection. VE of one and two vaccinations, versus unvaccinated, were estimated by age, medical risk, vaccine type and time since vaccination using Cox models with vaccination status as time-varying exposure. Additionally, we computed the NNV to prevent one hospitalisation. Among 14.3 million individuals in this study, 43,405 COVID-19 first-time hospitalisations were recorded. VE of two doses was >80 % in the first quarter post-vaccination across all strata. VE decreased over time, but vaccination remained protective three quarters post-vaccination. Among persons aged ≥60 years without medical risk conditions, VE was 96.1 %, 91.0 % and 84.9 % in the first, second and third quarter since vaccination. VE was lower and waned faster among persons with medical risk conditions: 91.1 %, 80.0 %, 70.8 % and 85.4 %, 73.4 %, 60.6 %, in the first three quarters post-vaccination in the moderate and high medical risk groups, respectively. Nonetheless, the NNV was lower among medical risk groups. These findings suggest that prioritising medical risk populations for booster vaccination was warranted. To adequately respond to future epidemics and optimise vaccination programmes, the data infrastructure should allow near-real-time stratified VE analyses.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100747"},"PeriodicalIF":2.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145525339","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}
Pub Date : 2025-12-01Epub Date: 2025-09-18DOI: 10.1016/j.jvacx.2025.100727
Tove Hoffman , Bo Albinsson , Linda Kolstad , Marika Nordberg , Sirkka Vene , Patrik Ellström , Bengt Rönnberg , Olli Vapalahti , Dag Nyman , Åke Lundkvist
Background
The Åland Islands included tick-borne encephalitis (TBE) vaccination in the general vaccination program in 2006.
Aim
Investigate the effect of the vaccination on the number of reported TBE cases and the TBEV IgG seroprevalence in blood donors in the Åland Islands.
Methods
We used reported data on TBE cases (1995–2018) and sera collected from blood donors in 1995 (n = 300) and 2018 (n = 300). Samples were analyzed by a Luminex-based method that can differentiate antibodies induced by a TBE virus (TBEV) infection from those produced after TBE vaccination.
Results
A weak negative trend but no significant relationship between the number of reported TBE cases and year was observed. Of the blood donors, 3.3 % and 7.0 % tested positive for a previous TBEV infection in 1995 and 2018, respectively. There was no significant difference between the blood donor cohorts regarding the number of TBEV-infected and non-infected individuals. The proportion of TBE vaccinated blood donors increased from 2.7 % in 1995 to 81.0 % in 2018. The proportion of previously TBEV-infected unvaccinated blood donors increased from 3.4 % in 1995 to 36.8 % in 2018. The estimated number of unvaccinated individuals decreased 3.8-fold from 1995 to 2018. The rate of TBE cases in the estimated unvaccinated population increased 3.9-fold between the years 1995 and 2018. The risk of being infected by TBEV tended to be higher in 2018, reduced for men, and to increase with age.
Conclusion
The strong increase in seroprevalence of anti-NS1 antibodies and increase of TBE cases in the estimated unvaccinated population seen in this study suggest that the low number of TBE cases in the Åland Islands is explained by the high vaccination coverage, suggesting a positive effect of the free TBE vaccination on public health in the Åland Islands.
{"title":"The effect of the TBE vaccination program in the Åland Islands","authors":"Tove Hoffman , Bo Albinsson , Linda Kolstad , Marika Nordberg , Sirkka Vene , Patrik Ellström , Bengt Rönnberg , Olli Vapalahti , Dag Nyman , Åke Lundkvist","doi":"10.1016/j.jvacx.2025.100727","DOIUrl":"10.1016/j.jvacx.2025.100727","url":null,"abstract":"<div><h3>Background</h3><div>The Åland Islands included tick-borne encephalitis (TBE) vaccination in the general vaccination program in 2006.</div></div><div><h3>Aim</h3><div>Investigate the effect of the vaccination on the number of reported TBE cases and the TBEV IgG seroprevalence in blood donors in the Åland Islands.</div></div><div><h3>Methods</h3><div>We used reported data on TBE cases (1995–2018) and sera collected from blood donors in 1995 (<em>n</em> = 300) and 2018 (<em>n</em> = 300). Samples were analyzed by a Luminex-based method that can differentiate antibodies induced by a TBE virus (TBEV) infection from those produced after TBE vaccination.</div></div><div><h3>Results</h3><div>A weak negative trend but no significant relationship between the number of reported TBE cases and year was observed. Of the blood donors, 3.3 % and 7.0 % tested positive for a previous TBEV infection in 1995 and 2018, respectively. There was no significant difference between the blood donor cohorts regarding the number of TBEV-infected and non-infected individuals. The proportion of TBE vaccinated blood donors increased from 2.7 % in 1995 to 81.0 % in 2018. The proportion of previously TBEV-infected unvaccinated blood donors increased from 3.4 % in 1995 to 36.8 % in 2018. The estimated number of unvaccinated individuals decreased 3.8-fold from 1995 to 2018. The rate of TBE cases in the estimated unvaccinated population increased 3.9-fold between the years 1995 and 2018. The risk of being infected by TBEV tended to be higher in 2018, reduced for men, and to increase with age.</div></div><div><h3>Conclusion</h3><div>The strong increase in seroprevalence of anti-NS1 antibodies and increase of TBE cases in the estimated unvaccinated population seen in this study suggest that the low number of TBE cases in the Åland Islands is explained by the high vaccination coverage, suggesting a positive effect of the free TBE vaccination on public health in the Åland Islands.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100727"},"PeriodicalIF":2.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145118942","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}
Cervical cancer is one of the most prevalent cancers affecting women especially in low- and middle income countries and is caused by persistent infection with human papillomavirus (HPV). HPV vaccination can significantly reduce the cervical cancer burden. However, HPV vaccination is not yet included in the Tunisian immunization program. To inform decision-making on HPV vaccine introduction in Tunisia, we conducted a comparative modeling study to project the health impact and cost-effectiveness of four HPV vaccines (Cecolin, Cervarix, Gardasil, 4, and Gardasil-9) targeted to 12-year-old girls in 2025.
Methods:
We used two static cohort models (UNIVAC and Papillomavirus Rapid Interface for Modeling and Economics (PRIME)) to estimate the health and economic impact of HPV vaccination from the health system and societal perspectives. Our data inputs to the model include demography and cervical cancer burden as well as unit costs for treatment, vaccines, and vaccine delivery. We estimated health impact in terms of cases, deaths, and disability-adjusted life years (DALYs) averted by HPV vaccination, and economic impact in terms of vaccination costs, treatment costs saved, net cost, and incremental cost-effectiveness ratios (ICERs).
Results:
We estimated that Cecolin is the most cost-effective HPV vaccine in Tunisia, particularly when cross-protection is considered. Despite Cervarix offering greater health benefits of 70% versus 62% reductions in cervical cancer cases and deaths at 87% coverage, Cecolin has lower net costs and is more favorable across different willingness-to-pay (WTP) thresholds. At a WTP of USD 1169 per DALY averted (30% of Tunisia’s GDP per capita), Cecolin and Cervarix demonstrate similar probabilities of being cost-effective.
Conclusion:
Based on the vaccine impact estimates generated by the UNIVAC and PRIME models, we inferred that the four HPV vaccines (Cecolin, Cervarix Gardasil,4, and Gardasil-9) were cost-effective in the Tunisian context. This evidence is useful to inform HPV vaccine introduction in Tunisia.
{"title":"Potential health impact and cost-effectiveness of human papillomavirus vaccination in Tunisia: A comparative modeling study","authors":"Oumaima Laraj , Beya Benzina , Ahlem Gzara , Amira Kebir , Kaja Abbas , Slimane BenMiled","doi":"10.1016/j.jvacx.2025.100712","DOIUrl":"10.1016/j.jvacx.2025.100712","url":null,"abstract":"<div><h3>Background:</h3><div>Cervical cancer is one of the most prevalent cancers affecting women especially in low- and middle income countries and is caused by persistent infection with human papillomavirus (HPV). HPV vaccination can significantly reduce the cervical cancer burden. However, HPV vaccination is not yet included in the Tunisian immunization program. To inform decision-making on HPV vaccine introduction in Tunisia, we conducted a comparative modeling study to project the health impact and cost-effectiveness of four HPV vaccines (Cecolin, Cervarix, Gardasil, 4, and Gardasil-9) targeted to 12-year-old girls in 2025.</div></div><div><h3>Methods:</h3><div>We used two static cohort models (UNIVAC and Papillomavirus Rapid Interface for Modeling and Economics (PRIME)) to estimate the health and economic impact of HPV vaccination from the health system and societal perspectives. Our data inputs to the model include demography and cervical cancer burden as well as unit costs for treatment, vaccines, and vaccine delivery. We estimated health impact in terms of cases, deaths, and disability-adjusted life years (DALYs) averted by HPV vaccination, and economic impact in terms of vaccination costs, treatment costs saved, net cost, and incremental cost-effectiveness ratios (ICERs).</div></div><div><h3>Results:</h3><div>We estimated that Cecolin is the most cost-effective HPV vaccine in Tunisia, particularly when cross-protection is considered. Despite Cervarix offering greater health benefits of 70% versus 62% reductions in cervical cancer cases and deaths at 87% coverage, Cecolin has lower net costs and is more favorable across different willingness-to-pay (WTP) thresholds. At a WTP of USD 1169 per DALY averted (30% of Tunisia’s GDP per capita), Cecolin and Cervarix demonstrate similar probabilities of being cost-effective.</div></div><div><h3>Conclusion:</h3><div>Based on the vaccine impact estimates generated by the UNIVAC and PRIME models, we inferred that the four HPV vaccines (Cecolin, Cervarix Gardasil,4, and Gardasil-9) were cost-effective in the Tunisian context. This evidence is useful to inform HPV vaccine introduction in Tunisia.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100712"},"PeriodicalIF":2.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145050302","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}
Pub Date : 2025-12-01Epub Date: 2025-11-17DOI: 10.1016/j.jvacx.2025.100757
Marissa Tan , Eman Addish , Shara Epstein , Danica Kuncio
Background
Routine newborn and childhood vaccinations for hepatitis B virus (HBV) in the U.S. have driven a decrease in HBV infections. In Philadelphia, reports of acute hepatitis B infections among fully vaccinated individuals prompted further investigation.
Methods
Among people with reported acute HBV occurring between 2018 and 2023, people born in 1981 or later were matched to vaccination and birth records. Additional data were collected via chart audits for clinical and risk factor information.
Results
Fifty-two acute HBV cases occurred between 2018 and 2023 among people born in 1981 or later. Approximately 13.5 % (n = 7) were known to have completed a three-dose series of HBV vaccination with appropriate dose intervals, six (85.7 %) completed the vaccination series as an infant. All seven cases had clinically and epidemiologically confirmed acute disease. All case persons had an immunocompromising condition, including 66.7 % (n = 4) with a history of nonmedical substance use documented during the time of acute HBV identification. All three case persons with HIV had evidence of negative hepatitis B surface antigen testing at the time of HIV diagnosis.
Conclusions
Breakthrough cases of acute hepatitis B were found among persons who completed the hepatitis B vaccination series since universal vaccination in childhood was recommended. Further characterization of risk factors acquired after completing the series and optimizing hepatitis B immunity in the vaccination process are warranted using large and comprehensive datasets, such as those of health systems.
{"title":"Acute hepatitis B infections reported among appropriately vaccinated individuals, Philadelphia: A Role for Booster Doses?","authors":"Marissa Tan , Eman Addish , Shara Epstein , Danica Kuncio","doi":"10.1016/j.jvacx.2025.100757","DOIUrl":"10.1016/j.jvacx.2025.100757","url":null,"abstract":"<div><h3>Background</h3><div>Routine newborn and childhood vaccinations for hepatitis B virus (HBV) in the U.S. have driven a decrease in HBV infections. In Philadelphia, reports of acute hepatitis B infections among fully vaccinated individuals prompted further investigation.</div></div><div><h3>Methods</h3><div>Among people with reported acute HBV occurring between 2018 and 2023, people born in 1981 or later were matched to vaccination and birth records. Additional data were collected via chart audits for clinical and risk factor information.</div></div><div><h3>Results</h3><div>Fifty-two acute HBV cases occurred between 2018 and 2023 among people born in 1981 or later. Approximately 13.5 % (<em>n</em> = 7) were known to have completed a three-dose series of HBV vaccination with appropriate dose intervals, six (85.7 %) completed the vaccination series as an infant. All seven cases had clinically and epidemiologically confirmed acute disease. All case persons had an immunocompromising condition, including 66.7 % (<em>n</em> = 4) with a history of nonmedical substance use documented during the time of acute HBV identification. All three case persons with HIV had evidence of negative hepatitis B surface antigen testing at the time of HIV diagnosis.</div></div><div><h3>Conclusions</h3><div>Breakthrough cases of acute hepatitis B were found among persons who completed the hepatitis B vaccination series since universal vaccination in childhood was recommended. Further characterization of risk factors acquired after completing the series and optimizing hepatitis B immunity in the vaccination process are warranted using large and comprehensive datasets, such as those of health systems.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100757"},"PeriodicalIF":2.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623630","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}
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