Vaccine最新文献

{"title":"Evaluation of a strategy to enhance the efficacy and ease of application of porcine reproductive and respiratory syndrome virus vaccines","authors":"Antonella Schiavone ,&nbsp;Jane C. Edwards ,&nbsp;Easha Vigneswaran ,&nbsp;Rory C.F. De Brito ,&nbsp;Harkeerat Hothi ,&nbsp;Jean-Pierre Frossard ,&nbsp;E. Sam Beechener ,&nbsp;Jay G. Calvert ,&nbsp;Christine Tait Burkard ,&nbsp;Monica Balasch ,&nbsp;Andrew V. Seaton ,&nbsp;Mark Stevens ,&nbsp;M. Keith Howard ,&nbsp;Simon P. Graham ,&nbsp;Tanja Opriessnig","doi":"10.1016/j.vaccine.2025.127757","DOIUrl":"10.1016/j.vaccine.2025.127757","url":null,"abstract":"<div><div>Control of porcine reproductive and respiratory syndrome viruses (PRRSV) is sometimes hindered by the suboptimal immunogenicity and efficacy of existing vaccines. In addition, not following vaccine storage and administration conditions on-farm can negatively impact on the efficacy of current vaccines and present barriers to the development of more efficacious vaccination strategies. To address these challenges, we evaluated whether a ‘prime and pull’ immunisation strategy combining a prime with a ‘needle-free’ solid dose formulation of modified live PRRSV-1 vaccine (MLV), and a nasal boost with inactivated PRRSV-1 administered by an automated jet device can enhance protection against challenge infection. Forty-five, 4-week-old, PRRSV naïve, piglets were divided into 5 groups; including a benchmark group (10 pigs, vaccinated with a liquid MLV delivered by intramuscular injection), a prime only group (10 pigs vaccinated with the solid dose MLV), a prime/pull group (10 pigs vaccinated with the solid dose MLV and boosted 3 weeks later by nasal inoculation with inactivated MLV), an unvaccinated challenge control group (10 pigs) and a naïve group (5 pigs, without vaccination and PRRSV challenge). Pigs were challenged with a PRRSV-1 field strain 35 days post-vaccination and necropsied 10 days post-challenge. PRRSV viremia and nasal shedding were inferred by RT-qPCR, and antibody responses were assessed in serum and bronchoalveolar lavage by ELISA and virus neutralisation test. Whilst the nasal inactivated vaccine boost failed to augment efficacy, the solid dose vaccine provided neutralising antibody responses and protection (reduced viremia, virus shedding and gross lung lesions) comparable to the standard needle and syringe inoculation of PRRSV MLV suspension. These data support the further development of the solid dose formulation technology as a practical alternative to conventional delivery of PRRSV MLV and other vaccines to pigs.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"64 ","pages":"Article 127757"},"PeriodicalIF":4.5,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145103264","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}

{"title":"Family spillover effects in cost-effectiveness analyses of vaccines","authors":"Yiran Qian ,&nbsp;Marie Phillips ,&nbsp;Amanda L. Eiden ,&nbsp;Cristina Carias ,&nbsp;Tara A. Lavelle","doi":"10.1016/j.vaccine.2025.127755","DOIUrl":"10.1016/j.vaccine.2025.127755","url":null,"abstract":"<div><h3>Objectives</h3><div>We evaluated how frequently vaccine cost-effectiveness analyses (CEAs) include family spillover effects, costs or health impacts on family members who care for or about patients, and how their inclusion affects results.</div></div><div><h3>Methods</h3><div>Using the Tufts CEA Registry, we performed a systematic review to identify English-language CEAs published from January 2013 to December 2022 from the societal perspective. We selected CEAs for the four vaccines most evaluated within our search, examined how frequently these CEAs included family spillover effects, and how this inclusion changed CEA results.</div></div><div><h3>Results</h3><div>Among 268 vaccine CEAs meeting inclusion criteria, the top four vaccines were: human papillomavirus (<em>n</em> = 21), influenza (<em>n</em> = 57), pneumococcal (<em>n</em> = 37), and rotavirus (<em>n</em> = 25). (137 studies, 51 % of total). Of these, 65 (47.4 %) included family spillover effects, predominately time costs (<em>n</em> = 64, 98.5 %). Only four studies (6.2 %) included family spillover health effects. From 30 studies, we created 266 pairs of incremental cost-effectiveness ratios (ICERs), with each pair consisting of one ICER calculated with and then without family spillover effects. We then compared each pair to assess the impact of including family spillover effects on the ICERs. With 29 ICERs (10.9 %), including family spillover changed the result from a positive ICER, with a positive cost and benefit, to cost-saving, with a negative cost and a positive benefit. In 30 cases (11.3 %), ICERs remained cost-saving and in 207 cases (77.8 %) ICERs remained positive, with and without spillover effects. Among these, 206 pairs (99.5 %) showed a mean ICER reduction of 18.8 %, while one pair (0.5 %) increased by 13.3 %.</div></div><div><h3>Conclusions</h3><div>Approximately half of vaccine CEAs in our sample excluded family spillover effects. When included, most added family spillover costs but rarely family health effects, and generally showed more favorable results. Future vaccine CEAs should appropriately include family spillover effects to reflect vaccines' full value and support evidence-based decision-making.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"64 ","pages":"Article 127755"},"PeriodicalIF":4.5,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145103265","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}

{"title":"Safety and immunogenicity of SpiN-Tec, a T-cell based RBD-Nucleocapsid chimeric vaccine for COVID-19","authors":"Gregório Guilherme Almeida ,&nbsp;Jorge Andrade Pinto ,&nbsp;Patrícia Machado Pinto ,&nbsp;Ludmila Bezerra da Silva ,&nbsp;Luis Adan Flores Andrade ,&nbsp;Bruno Vinícius Santos Valiate ,&nbsp;Nathália Zini ,&nbsp;Flávia Fonseca Bagno ,&nbsp;Graziella Gomes Rivelli ,&nbsp;Karine Lima Lourenço ,&nbsp;Jéssica Pauline Coelho Souza ,&nbsp;Isabela Pereira Gomes ,&nbsp;Natália Salazar de Castro ,&nbsp;Ana Luiza Chaves Maia ,&nbsp;Alex Fiorini de Carvalho ,&nbsp;Júlio Castro Alves ,&nbsp;Júlia Teixeira de Castro ,&nbsp;Guangzhao Li ,&nbsp;Gabriel da Rocha Fernandes ,&nbsp;Pedro Augusto Alves ,&nbsp;Helton da Costa Santiago","doi":"10.1016/j.vaccine.2025.127756","DOIUrl":"10.1016/j.vaccine.2025.127756","url":null,"abstract":"<div><div>The SpiN-Tec MCTI UFMG is a chimeric recombinant protein (SpiN) containing the RBD region from the Spike protein (S) fused with the Nucleocapsid protein (N), adjuvanted with a squalene-based emulsion (CTVad1), which was developed as booster COVID-19 vaccine. This is a phase I clinical trial to evaluate safety and reactogenicity. Thirty-six healthy adults aged 18–54, previously vaccinated with two doses of CoronaVac™ (Sinovac) and a booster with the Comirnaty™ Bivalent BA.4/BA.5 (Pfizer-BioNTech), were randomized to receive either SpiN-Tec (20 μg, 60 μg, or 100 μg) or CoviShield™(AstraZeneca). SpiN-Tec was safe and showed a reactogenic profile comparable to CoviShield. Immunogenicity results showed a dose-dependent increase in IgG levels against N and SpiN, peaking at day 28 post-vaccination and declining by day 180. Neutralizing antibody levels against both the Wuhan ancestral and BA1.88 strains showed similar curves presenting no differences between SpiN-Tec and CoviShield. Importantly, SpiN-Tec induced robust IFN-γ production up to 270 days, particularly by CD4⁺ effector memory T cells, indicating a durable immune response memory. These results indicate the potential of SpiN-Tec as a viable COVID-19 booster vaccine.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"64 ","pages":"Article 127756"},"PeriodicalIF":4.5,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145103272","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}

{"title":"Effectiveness of JN.1 monovalent COVID-19 vaccination in EU/EEA countries between October 2024 and January 2025: a VEBIS electronic health record network study","authors":"James Humphreys ,&nbsp;Alexandre Blake ,&nbsp;Nathalie Nicolay ,&nbsp;Toon Braeye ,&nbsp;Izaak Van Evercooren ,&nbsp;Christian Holm Hansen ,&nbsp;Ida Rask Moustsen-Helms ,&nbsp;Chiara Sacco ,&nbsp;Alberto Mateo-Urdiales ,&nbsp;Jesús Castilla ,&nbsp;Iván Martínez-Baz ,&nbsp;Ausenda Machado ,&nbsp;Andre Brito ,&nbsp;Rickard Ljung ,&nbsp;Nicklas Pihlstrom ,&nbsp;Yohann Mansiaux ,&nbsp;Susana Monge ,&nbsp;Sabrina Bacci ,&nbsp;Baltazar Nunes ,&nbsp;VEBIS-EHR working group","doi":"10.1016/j.vaccine.2025.127752","DOIUrl":"10.1016/j.vaccine.2025.127752","url":null,"abstract":"<div><div>We estimated vaccine effectiveness (VE) of Omicron JN.1-adapted COVID-19 vaccines administered during the 2024 autumnal vaccination campaign against COVID-19 hospitalisation and death among eligible individuals aged ≥65 years. The study period was October 2024–January 2025. Using a common protocol across six EU/EEA study sites, we linked electronic health records to construct retrospective cohorts and applied Cox modelling to estimate VE via confounder-adjusted hazard ratios.</div><div>The majority of vaccines administered during the study period were Omicron JN.1-adapted COVID-19 vaccines (99 %). VE against hospitalisation was 60 % (95 % Confidence Interval: 48–70 %) and against COVID-19-related death was 78 % (95 %CI: 64–87 %) among individuals aged 65–79 years; 58 % (95 %CI: 48–66 %) and 62 % (95 %CI: 32–79 %) among those aged ≥80 years.</div><div>These results indicate high effectiveness in the initial months of the campaign. Continued monitoring is necessary to confirm these results, including estimates of VE in those with longer time since vaccination and during different variant predominance periods.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"64 ","pages":"Article 127752"},"PeriodicalIF":4.5,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145103273","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}

{"title":"Qualification of a reporter virus microneutralization assay for evaluation of influenza specific antibodies in human clinical trials","authors":"Dimple Harit ,&nbsp;Sheetal Sawant ,&nbsp;Rachel L. Spreng ,&nbsp;Sarah Gurley ,&nbsp;Allison Schechter ,&nbsp;Angelina Sharak ,&nbsp;Andrew Bae ,&nbsp;Adrian Creanga ,&nbsp;Masaru Kanekiyo ,&nbsp;Zhongli Li ,&nbsp;Marcella Sarzotti-Kelsoe ,&nbsp;Emmanuel B. Walter ,&nbsp;M. Anthony Moody ,&nbsp;Georgia D. Tomaras","doi":"10.1016/j.vaccine.2025.127699","DOIUrl":"10.1016/j.vaccine.2025.127699","url":null,"abstract":"<div><div>Neutralizing antibodies can block the entry of viruses into host cells. Next-generation influenza vaccines should stimulate the production of high levels of neutralizing antibodies capable of preventing influenza infection or reducing the severity of disease. Currently, multiple assays and protocols are used to measure influenza neutralization and there is a critical need to compare antibody responses elicited by different candidate vaccines tested in different populations to advance the most promising vaccine candidates to efficacy studies and licensure. A standardized approach for safely testing human sera against influenza viruses is to employ replication restricted reporter influenza viruses in which an essential viral gene (i.e., polymerase basic 1, PB1, gene) is replaced with a reporter gene. The replication restricted reporter viruses can be propagated in specific cell lines expressing the deleted viral gene, which make them suitable for biosafety level 2 (BSL-2) laboratory. Qualification of this method is needed for standardized testing in human clinical trials.</div><div>In compliance with Good Clinical Laboratory Practice (GCLP) guidelines, we qualified a reporter virus microneutralization method by evaluating linearity, precision, accuracy, range, limits of detection and quantitation, specificity and robustness for A/New Caledonia/20/1999 (H1N1). We utilized unique sets of human clinical trial samples positive for influenza specific antibodies to enable development and testing. We compared the reporter virus microneutralization assay to the standard microneutralization assay with three additional viruses: A/California/07/2009 (H1N1), A/Singapore/INFIMH-16-0019/2016 (H3N2) and A/Texas/71/2017 (H3N2). The qualified reporter virus microneutralization assay was linear (R2 = 0.99, <em>p</em>-value &lt;0.0001), precise (0–8 % GCV repeatability), accurate (%RE −18 to −12 %) with LLOQ of 19.4, robust for laboratory testing conditions (i.e. incubation times, temperature) and correlated with the traditional microneutralization assay (Spearman's <em>r</em> = 0.84–0.98, <em>p</em> &lt; 0.001 for four virus strains). This qualified method will enable defining correlates of protection and contribute to meta-analyses of future human clinical trials.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"64 ","pages":"Article 127699"},"PeriodicalIF":4.5,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145103275","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}

{"title":"Changes in the Streptococcus pneumoniae population responsible for invasive disease of young children after the implementation of conjugated vaccines in the National Immunization Program in Poland","authors":"Izabela Wróbel-Pawelczyk ,&nbsp;Agnieszka Gołębiewska ,&nbsp;Patrycja Ronkiewicz ,&nbsp;Marlena Kiedrowska ,&nbsp;Kinga Błaszczyk ,&nbsp;Alicja Kuch ,&nbsp;Ewa Sadowy ,&nbsp;Waleria Hryniewicz ,&nbsp;David Litt ,&nbsp;Natalie Groves ,&nbsp;Anna Skoczyńska","doi":"10.1016/j.vaccine.2025.127759","DOIUrl":"10.1016/j.vaccine.2025.127759","url":null,"abstract":"<div><h3>Background</h3><div>In Poland, 10-valent pneumococcal conjugate vaccine (PCV10) was added to the National Immunization Program (NIP) in 2017. We aimed to investigate the population structure and genomic composition of pneumococcal strains responsible for invasive infections in young children before and after the introduction of PCV10 to the NIP.</div></div><div><h3>Methods</h3><div>The study encompassed all laboratory-confirmed cases of invasive pneumococcal disease between 2014 and 2020 in Polish children under the age of two. This period was split into two phases: the pre-PCV period (2014–2016) and the post-PCV period (2017–2020). Standard methods were utilized for identifying, serotyping, and testing the antimicrobial susceptibility of the isolates. All <em>S. pneumoniae</em> isolates underwent whole genome sequencing and analysis.</div></div><div><h3>Results</h3><div>Following the introduction of PCV10, the prevalence of PCV10 vaccine-type (PCV10-VT) strains decreased significantly from 56.9 % to 29.5 %. Concurrently, the additional three serotypes present in higher valency PCVs (3, 6A and 19A), increased from 17.6 % to 25.7 %, and non-vaccine serotypes from 12.8 % to 22.9 %. A significant decline was observed in resistance to penicillin (49.0 %–34.3 %), and erythromycin (55.9 %–41.9 %), in the percentage of multidrug-resistant (46.1 %–30.5 %), and pilliated isolates (50.0 %–28.6 %). In the pre-PCV period, Global Pneumococcal Sequence Cluster (GPSC), GPSC1 was the most prevalent (17.6 %), and in the post-PCV period GPSC12 emerged as the most common (10.5 %). Changes in the GPSC composition within particular serotypes (e.g. 14 and 19A) were also observed.</div></div><div><h3>Conclusions</h3><div>In the first three years after the introduction of the PCV10 into the Polish NIP significant reduction in the prevalence of PCV10-VTs was observed. Molecular characterization of the studied population allowed us to link the observed changes in the GPSC prevalence, with a decrease of infections caused by multi-drug resistant pneumococci and those with higher virulence associated with the presence of pili. The consistent evolution of <em>S. pneumoniae</em> influenced by population-based vaccinations, requires continuous surveillance.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"64 ","pages":"Article 127759"},"PeriodicalIF":4.5,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145103271","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}

{"title":"The 1904 Rio De Janeiro vaccine revolt: Resistance to compulsory smallpox vaccination","authors":"José Esparza ,&nbsp;Clarissa R. Damaso","doi":"10.1016/j.vaccine.2025.127774","DOIUrl":"10.1016/j.vaccine.2025.127774","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"64 ","pages":"Article 127774"},"PeriodicalIF":4.5,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145103262","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}

{"title":"Assessment of critical bioprocess parameters for broadly cross-reactive chimeric hemagglutinin influenza virus vaccines","authors":"Michael J. Scherm ,&nbsp;Robert Hölzl ,&nbsp;Irene González-Domínguez ,&nbsp;Richard Hjorth ,&nbsp;Sean S. Chiou ,&nbsp;Maureen F. Maughan ,&nbsp;Diana Martik ,&nbsp;Florian Krammer ,&nbsp;Eduard Puente-Massaguer","doi":"10.1016/j.vaccine.2025.127671","DOIUrl":"10.1016/j.vaccine.2025.127671","url":null,"abstract":"<div><div>Antigenic drift of seasonal influenza viruses and unpredictable outbreaks with new influenza virus subtypes are a global concern that requires the development of broadly protective vaccines. We previously showed that chimeric hemagglutinin (cHA) virus vaccines are an effective strategy to elicit cross-protective immune responses to the conserved hemagglutinin (HA) stalk domain. However, the critical bioprocess parameters and vaccine quality attributes for cHA inactivated split constructs remain to be defined. Here, we developed an egg-based bioprocess for inactivated virus vaccine production with special focus on group 2 cHA viruses (cH15/3_HK14N2_HK14). The egg inoculum dose, incubation temperature and time, the high-speed centrifugation step, reversing the order of virus inactivation and splitting, and incorporating a sterile filtration step were thoroughly investigated. We also demonstrated that the selected virus inactivation conditions result in complete virus inactivation and defined an optimal detergent concentration in the final vaccine preparation. Using the optimal conditions, at least a 2-fold increase in HA yield was achieved for the cH15/3_HK14N2_HK14 virus in comparison with the unoptimized bioprocess. Vaccines produced using regular bioprocess conditions (virus inactivation first) or reversing the inactivation and splitting steps were equally immunogenic in mice, elicited antibody responses against the HA and neuraminidase (NA), and showed to be antigenically stable in different storage conditions. This study will support the development of cHA virus vaccines in a phase I clinical trial.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"64 ","pages":"Article 127671"},"PeriodicalIF":4.5,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093377","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}

{"title":"Immunogenicity and safety of a meningococcal a conjugate vaccine administered with routine EPI vaccines in African infants and toddlers","authors":"Abraham Hodgson ,&nbsp;Fadima Cheick Haidara ,&nbsp;Samba O. Sow ,&nbsp;Patrick Odum Ansah ,&nbsp;Nana Akosua Ansah ,&nbsp;Milagritos D. Tapia ,&nbsp;Oscar Bangre ,&nbsp;Godwin C. Enwere ,&nbsp;Simonetta Viviani ,&nbsp;Elisa Marchetti ,&nbsp;Emanuele Montomoli ,&nbsp;Valerio Stanzani ,&nbsp;Yuxiao Tang ,&nbsp;Brian Plikaytis ,&nbsp;Varsha Parulekar ,&nbsp;Lionel Martellet ,&nbsp;Julie Chaumont ,&nbsp;Marie-Françoise Makadi ,&nbsp;Prasad S. Kulkarni ,&nbsp;George Carlone ,&nbsp;Marie-Pierre Preziosi","doi":"10.1016/j.vaccine.2025.127698","DOIUrl":"10.1016/j.vaccine.2025.127698","url":null,"abstract":"<div><div>In 2010, a Meningococcal group A (MenA) conjugate vaccine (PsA-TT) was WHO prequalified and introduced in preventive campaigns in 1–29 year-olds across the African Meningitis Belt. An extension of the indication to infants and toddlers in the Expanded Programme on Immunization (EPI) was pursued for the protection of new birth cohorts.</div><div>Between 2008 and 2012, a Phase 2 randomized controlled trial was conducted in Ghana to assess the safety and immunogenicity of different PsA-TT formulations (10 μg, 5 μg or 2.5 μg of MenA polysaccharide) given as one or two doses with EPI vaccines at 14–18 weeks, 9–12 months, and 12–18 months of age (Study A). Between 2012 and 2013, a subsequent Phase 3 randomized controlled trial was conducted in Mali to assess the 10 μg and 5 μg formulations given as one or two doses with EPI vaccines at 9–12 and 15–18 months of age (Study B). Immunogenicity was assessed using a serum bactericidal antibody assay using rabbit complement (rSBA).</div><div>Non-inferiority of the 5 μg and 2.5 μg PsA-TT formulations to the 10 μg formulation was demonstrated in Study A with ≥93 % seroconversion in MenA rSBA 28 days after each dose. Non-inferiority of the 5 μg to the 10 μg was demonstrated in Study B in terms of seroconversion in MenA rSBA at 28 days (≥97 %) when given as two doses at 9–12 and 15–18 months and as a single dose at 9–12 months. Non-inferiority with respect to most EPI antigens was demonstrated in pairwise comparisons across both studies. Adverse events and serious adverse events reported in either study following vaccinations were similar across vaccine groups.</div><div>Results of both trials showed that the vaccine was safe and immunogenic when co-administered with the EPI, paving the way for a WHO recommendation for the 5 μg PsA-TT to be included in the EPI as a single dose at 9–18 months of age.</div><div>PsA-TT-004, registered International Standard Randomized Controlled Trial Number: ISRCTN82484612; PsA-TT-007, International registration number: PACTR201110000328305.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"64 ","pages":"Article 127698"},"PeriodicalIF":4.5,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145088613","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}

{"title":"Exceptional high number of IPD cases in winter season 2024–2025 in Belgium in concomitance with rise in vaccine serotypes","authors":"Lize Cuypers ,&nbsp;Cato Dambre ,&nbsp;Stefanie Desmet","doi":"10.1016/j.vaccine.2025.127763","DOIUrl":"10.1016/j.vaccine.2025.127763","url":null,"abstract":"<div><div>Following lifting of containment measures post-COVID, the number of invasive pneumococcal disease (IPD) infections continued to increase, reaching a record number last winter season 2024–2025 in Belgium. This exceptional increase is largely due to high numbers in (older) adults, and mainly an increase of vaccine serotype IPD. Over 95 % of IPD cases last winter could theoretically be prevented by vaccination. Cases of serotypes 12F, 14 and 4 were three or more times higher compared to pre-COVID winter season 2019–2020.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"64 ","pages":"Article 127763"},"PeriodicalIF":4.5,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145088628","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}