Vaccine最新文献

{"title":"How text message reminders increase COVID-19 booster vaccine uptake: Two randomized controlled trials","authors":"Arne Meeldijk ,&nbsp;Lisa Vandeberg ,&nbsp;Reinier Akkermans ,&nbsp;Jeannine Hautvast","doi":"10.1016/j.vaccine.2024.126533","DOIUrl":"10.1016/j.vaccine.2024.126533","url":null,"abstract":"<div><h3>Background</h3><div>Vaccines are effective and affordable health prevention measures to prevent vaccine-preventable diseases, but achieving sufficient vaccine uptake population-wide is challenging. In this work, we assess the impact of various text messages reminders on COVID-19 booster uptake and the extent to which the effect of messages holds over time. Additionally, we analyse whether people's self-reported vaccination intentions (measured in response to message prompts) corresponds to actual vaccine uptake and whether this relationship differs between message variants.</div></div><div><h3>Methods</h3><div>We performed two large sequential randomized controlled trials (RCTs) in the Netherlands (<em>N =</em> 140.973), with the design of RCT2 building on the findings of RCT1. We 1) analyzed the effect of various text messages on COVID-19 booster uptake; 2) assessed the extent to which these effects hold over time; and 3) tested whether a positive response to message prompts moderates the effect of message variant on vaccine uptake.</div></div><div><h3>Results</h3><div>First, the results of RCT1 demonstrate that text messages with an <em>ownership frame</em> (“your [vaccine] is ready for you”) result in highest vaccine uptake (e.g., compared to no text message: OR = 1.28 [99 % CI 1.03–1.59]). RCT2 showed that text messages with an <em>ownership frame</em> and a <em>specific date</em>, <em>time and location</em> result in highest vaccine uptake (e.g., compared to no text message: OR = 2.10 [99 % CI 1.85–2.38]). Second, most message effects hold over a longer period of time (e.g., ‘date, time, location’ message versus no message: OR = 2.10 [99 % CI 1.85–2.38] on day 6 and OR = 1.36 [99 % CI 1.25–1.48] on day 50). Third, we find that participants who received our most effective text and replied that they will take the vaccine, are more inclined to actually take the vaccine compared to the message with broad opening hours OR = 2.86 [99 % CI 2.14–3.82].</div></div><div><h3>Conclusion</h3><div>Text message reminders are able to increase vaccine uptake. From the tested variations, messages with an <em>ownership</em> frame providing a <em>specific date, time and location</em> are most effective. Because text messages demonstrate no notable disadvantages, we advise Public Health authorities to include this effective intervention in their vaccination campaign strategies.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126533"},"PeriodicalIF":4.5,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142677486","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":"Vaccine efficacy induced by 2020-2021 seasonal influenza-derived H3N1 virus-like particles co-expressing M2e5x or N2","authors":"Jie Mao ,&nbsp;Hae-Ji Kang ,&nbsp;Gi-Deok Eom ,&nbsp;Keon-Woong Yoon ,&nbsp;Ki Back Chu ,&nbsp;Fu-Shi Quan","doi":"10.1016/j.vaccine.2024.126530","DOIUrl":"10.1016/j.vaccine.2024.126530","url":null,"abstract":"<div><div>Influenza A matrix protein 2 (M2e) and neuraminidase (NA) antigens are known to play important roles in mounting a broad range of protection. Nonetheless, the protective efficacy of the VLP vaccines co-expressing both M2e and NA antigens has not been explored. In this study, we generated 2020/2021 seasonal influenza H3N1 VLPs that co-expressed either M2e5x (H3N1M2e5x) or N2 (H3N1N2 VLP) antigens. The protective efficacy of these VLPs was assessed by challenge infection with heterologous H3N2 and heterosubtypic H1N1 and H5N1 viruses in mice. Both VLP formulations induced cross-protection against distinct viruses, H3N1M2e5x VLPs elicited higher levels of cross-reactive IgG in sera against H1N1 and H5N1 viruses than H3N1N2 VLPs. Compared to H3N1N2 VLPs, H3N1M2e5x VLPs also induced substantially enhanced germinal center B cell responses while inhibiting IFN-γ production in the lungs. Importantly, H3N1M2e5x VLPs significantly reduced the lung virus titers upon H1N1, H3N2, and H5N1 challenge infections. These results indicated that VLPs comprising the M2e5x antigen are a promising vaccine design strategy that could aid in the pursuit of a universal influenza vaccine.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126530"},"PeriodicalIF":4.5,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142650090","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":"Improving the timeliness and equity of preschool childhood vaccinations: Mixed methods evaluation of a quality improvement programme in primary care","authors":"Milena Marszalek ,&nbsp;Meredith K.D. Hawking ,&nbsp;Ana Gutierrez ,&nbsp;Nicola Firman ,&nbsp;Jianhua Wu ,&nbsp;John Robson ,&nbsp;Kelvin Smith ,&nbsp;Isabel Dostal ,&nbsp;Zaheer Ahmed ,&nbsp;Helen Bedford ,&nbsp;Anna Billington ,&nbsp;Carol Dezateux","doi":"10.1016/j.vaccine.2024.126522","DOIUrl":"10.1016/j.vaccine.2024.126522","url":null,"abstract":"<div><h3>Background</h3><div>We conducted a mixed methods evaluation to assess whether implementing a primary care quality improvement (QI) programme utilising a digital call-and-recall tool improved timely receipt and equity of first measles, mumps and rubella (MMR) and diphtheria tetanus, pertussis and polio-containing (DTaP /IPV) vaccinations.</div></div><div><h3>Methods</h3><div>138,133 and 136,952 children were eligible to receive first MMR and DTaP/IPV respectively between 1st January 2019 and 31st January 2024 in North East London. We compared proportions with timely first MMR or DTaP/IPV receipt (by ages 18 and six months respectively) pre- and post-implementation using an interrupted time series analysis. We calculated change in the Slope Index of Inequality (SII) by an area-level deprivation measure. We conducted ‘Think Aloud’ exercises and semi-structured interviews with users.</div></div><div><h3>Findings</h3><div>The proportion of children with timely first MMR receipt increased by 5·3 % (Rate Ratio [RR]:1·053, 95 % confidence interval [CI]:1·033–1·073), equating to an absolute increase in timely MMR receipt of 4·1 % - from 77·7 % to 81·8 % - and for first DTaP/IPV by 0·9 % (RR:1·009, 95 % CI:1·003–1·015). There was no significant change in SII for either vaccine. Users reported improved recall with tool use, but identified practice-level and systemic barriers, including staff dynamics and unachievable national targets, limiting its consistent use.</div></div><div><h3>Interpretation</h3><div>In a real-world setting, a call-and-recall tool within a primary care QI programme improved timely first MMR receipt. Sustained improvement requires additional support including by incentivising achievable targets and improving staff capacity and training.</div></div><div><h3>Funding</h3><div>National Institute of Health and Care Research; Barts Charity.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126522"},"PeriodicalIF":4.5,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142650088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of a standardized human complement serum bactericidal activity assay to measure functional antibody responses to Neisseria gonorrhoeae","authors":"Kathryn A. Matthias ,&nbsp;Alexandra Reveille ,&nbsp;Kumaresh Dhara ,&nbsp;Christopher S. Lyle ,&nbsp;Robert J. Natuk ,&nbsp;Brian Bonk ,&nbsp;Margaret C. Bash","doi":"10.1016/j.vaccine.2024.126508","DOIUrl":"10.1016/j.vaccine.2024.126508","url":null,"abstract":"<div><div>The recent entry of multiple vaccines targeting <em>Neisseria gonorrhoeae</em> (<em>Ng</em>) into the clinical development pathway has highlighted the need to establish methods of adequately assessing anti-gonococcal immune responses. Serum bactericidal activity (SBA) is utilized as a measurement of efficacy in licensure of meningococcal vaccines, but the importance of functional antibodies in preventing and/or clearing gonococcal infections remains largely unknown. In an effort to elucidate the utility of SBA as an immune correlate of protection, we sought to develop a standardized high-throughput human complement SBA (hSBA) assay for which any strain of interest could be tested under uniform conditions, with minimal screening of complement required. Utilization of IgG/IgM-depleted pooled human complement serum permitted testing of diverse serum resistant and sensitive gonococcal and unencapsulated meningococcal strains when bacteria were cultured to induce lipooligosaccharide sialylation; only one of nine randomly selected lots demonstrated intrinsic toxicity. The hSBA assay was well suited for use with multiple test serum sources, including rabbit, mouse, and human serum samples, suggesting widespread applicability.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126508"},"PeriodicalIF":4.5,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142645320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immunogenicity and protection of a triple repeat domain III mRNA vaccine against Zika virus","authors":"Yu-Sun Lee ,&nbsp;Mi Sun Cheong ,&nbsp;Jisun Lee ,&nbsp;Eun-Kyoung Bang ,&nbsp;Sang In Park ,&nbsp;Hyo-Jung Park ,&nbsp;Seo-Hyeon Bae ,&nbsp;Subin Yoon ,&nbsp;Gahyun Roh ,&nbsp;Seonghyun Lee ,&nbsp;Youngran Cho ,&nbsp;Dahyeon Ha ,&nbsp;Ayoung Oh ,&nbsp;Soo-Yeon Lee ,&nbsp;Eun-Jin Choi ,&nbsp;Huijeong Choi ,&nbsp;Sohee Jo ,&nbsp;Yeeun Lee ,&nbsp;Jungmin Kim ,&nbsp;Hye Won Kwak ,&nbsp;Wonil Kim","doi":"10.1016/j.vaccine.2024.126518","DOIUrl":"10.1016/j.vaccine.2024.126518","url":null,"abstract":"<div><div>Zika virus (ZIKV) infection is primarily transmitted by mosquitoes and often asymptomatic in most individuals. Infection during pregnancy can lead to severe birth defects such as congenital microcephaly, and currently, there is no approved vaccine for ZIKV. Several studies are investigating the development of ZIKV vaccine using DNA and RNA as well as recombinant protein technologies; however, the outcomes thus far have not been consistently noteworthy. In this study, we designed an mRNA vaccine for ZIKV and evaluated its immunogenicity using a mouse model. Our vaccine, termed 3xEIII, encodes a triple repeat of domain III from the ZIKV E protein. We effectively encapsulated the mRNA within lipid nanoparticles (LNPs), administered 3xEIII to mice via two intramuscular injections, and assessed the induced humoral and cellular immune responses. Specifically, the vaccine elicited neutralizing antibodies that effectively eliminated ZIKV from the organs of challenged mice. Notably, 3xEIII conferred both protective effects and long-term immunity. In subsequent challenges conducted 40 weeks after boosting, immunized mice experienced temporary weight loss but showed significantly reduced viral titers in target organs by the 9th day post-infection. Conclusively from these findings, 3xEIII stands out as a promising noteworthy mRNA vaccine candidate for Zika virus.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126518"},"PeriodicalIF":4.5,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142640542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Live-attenuated vaccine failure after liver transplantation: A 20-year cohort study","authors":"Munehiro Furuichi ,&nbsp;Takuma Ohnishi ,&nbsp;Mizuki Yaginuma ,&nbsp;Yohei Yamada ,&nbsp;Ken Hoshino ,&nbsp;Tetsuo Nakayama ,&nbsp;Masayoshi Shinjoh","doi":"10.1016/j.vaccine.2024.126527","DOIUrl":"10.1016/j.vaccine.2024.126527","url":null,"abstract":"<div><h3>Background</h3><div>A recent conditional recommendation suggests considering live-attenuated vaccines for solid organ transplant recipients, yet the conditions of their safe and effective administration remain unclear.</div></div><div><h3>Methods</h3><div>This prospective study was conducted at Keio University Hospital from 2002 to August 2023. We gave a live-attenuated vaccine to liver transplant (LT) recipients fulfilling criteria for live-attenuated vaccines, including criteria for humoral and cell-mediated immunity. Patient background information, immunization date, vaccine strain, immunosuppressive agents at the time of vaccination, and antibody titers were collected. Factors related to primary and secondary vaccine failure were evaluated to enhance the effectiveness of the live-attenuated vaccine program after LT.</div></div><div><h3>Results</h3><div>Among 67 LT recipients, 54, 55, 47, and 55 received at least one dose of live-attenuated vaccine for measles, rubella, varicella, and mumps, respectively. The difference in vaccine strains, but not the use of two or more immunosuppressive agents, was associated with a lower risk of vaccine failures. Measles vaccine with the AIK-C strain exhibited significantly lower primary and secondary failure rates than the CAM-70 strain (1/38 vs. 4/16, odds ratio: 0.08, 95 % confidence interval [CI]: 0.01–0.80, <em>p</em> = 0.02, and hazard ratio: 0.54, 95 % CI: 0.34–0.85, <em>p</em> = 0.01, respectively). No primary failures were observed with the TO-336 strain of rubella, whereas 4 of 10 LT recipients with the Matsuura strain of rubella did not seroconvert. For mumps, the Hoshino strain showed lower primary failure rates than the Torii strain (15/52 vs. 3/3, <em>p =</em> 0.03).</div></div><div><h3>Conclusion</h3><div>According to a 20-year long-term study, vaccine strains are the most critical factor influencing primary and secondary vaccine failure in post-transplant live-attenuated vaccination.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126527"},"PeriodicalIF":4.5,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142640541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a candidate vaccine against severe fever with thrombocytopenia syndrome virus using Gn/Gc glycoprotein via multiple expression vectors delivered by attenuated Salmonella confers effective protection in hDC-SIGN transduced mice","authors":"Ji-Young Park,&nbsp;Amal Senevirathne,&nbsp;John Hwa Lee","doi":"10.1016/j.vaccine.2024.126524","DOIUrl":"10.1016/j.vaccine.2024.126524","url":null,"abstract":"<div><div>In this study, we developed two plasmid constructs, pJHL270 and pJHL305, for the dual expression of Severe Fever with Thrombocytopenia Syndrome Virus (SFTSV) Gn and Gc glycoproteins in both prokaryotic and eukaryotic systems. The constructs feature a prokaryotic expression controlled by the Ptrc promoter and a eukaryotic expression driven by the cytomegalovirus promoter and Semliki Forest Virus RNA-dependent RNA polymerase. The Gn/Gc antigenic epitope was derived from consensus sequences of 12 SFTSV M segments collected in South Korea and designed for optimal antigen expression. The full antigen was expressed eukaryotically for post-translational modifications, while the epitope construct was expressed prokaryotically. These constructs were electroporated into an attenuated <em>Salmonella Typhimurium</em> strain (JOL2500) for plasmid delivery, resulting in JOL3042 and JOL3045. Successful expression was confirmed via qRT-PCR and western blot analysis. Mice immunized with JOL3042 showed antibody responses as early as two weeks, while JOL3045 elicited responses at six weeks, skewed toward a Th1 response initially, later balancing with Th2. Flow cytometry revealed significant CD3⁺CD4⁺ and CD3⁺CD8⁺ T-cell responses. Both constructs generated neutralizing antibodies, and a challenge study indicated significant reductions in viral loads in the serum, liver, and spleen of vaccinated mice, demonstrating the effectiveness of the <em>Salmonella</em>-mediated delivery system against SFTSV infection. The outcome of the current study may pave the way to develop a safer and more effective <em>Salmonella-mediated</em> vaccine against lethal SFTSV infection in vulnerable populations.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126524"},"PeriodicalIF":4.5,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142640540","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":"Report from the World Health Organization's immunization and vaccines-related implementation research advisory committee (IVIR-AC) meeting, virtual gathering, 10–13 September 2024","authors":"Philipp Lambach ,&nbsp;Sheetal Silal ,&nbsp;Alyssa N. Sbarra ,&nbsp;Mitsuki Koh ,&nbsp;Rakesh Aggarwal ,&nbsp;Habib Hasan Farooqui ,&nbsp;Stefan Flasche ,&nbsp;Alexandra B. Hogan ,&nbsp;Sun-Young Kim ,&nbsp;Kathy Leung ,&nbsp;William J. Moss ,&nbsp;Patrick K. Munywoki ,&nbsp;Allison Portnoy ,&nbsp;Meru Sheel ,&nbsp;Xuan-Yi Wang","doi":"10.1016/j.vaccine.2024.126519","DOIUrl":"10.1016/j.vaccine.2024.126519","url":null,"abstract":"<div><div>The Immunization and Vaccines-related Implementation Research Advisory Committee (IVIR-AC) is the primary advisory body of the World Health Organization conducting independent reviews of immunization-related implementation research, with a primary focus on transmission and economic modeling analyses that estimate the value and impact of vaccines. From 10 to 13th September 2024, IVIR-AC convened virtually for its second of two semi-annual meetings to provide feedback and recommendations across six sessions including: pneumococcal vaccination strategies that rely on indirect protection; vaccine impact modeling for chikungunya; The Lancet Commission on strengthening the use of epidemiological modeling of emerging and pandemic infectious diseases; methods for immunization coverage estimation; setting immunization research priorities in the South-East Asian Region; and modeling evidence related to typhoid conjugate vaccine schedules. This report summarizes the sessions, proceedings, and recommendations from that meeting.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126519"},"PeriodicalIF":4.5,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142635268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A three antigen hepatitis B vaccine induces T cells to Pres1 and Pres2 which correlate with anti HBs antibody titers: An investigation into the immunological mechanisms contributing to high anti-HBs titers","authors":"Tamara K. Berthoud ,&nbsp;Tanvir Ahmed ,&nbsp;Warner Nadia ,&nbsp;Illia Petrov ,&nbsp;Lanjian Yang ,&nbsp;Danni Colledge ,&nbsp;Rachel Hammond ,&nbsp;Catalina Soare ,&nbsp;Barthelemy Ontsouka ,&nbsp;Daniel Plaskin ,&nbsp;David E. Anderson ,&nbsp;Francisco Diaz-Mitoma","doi":"10.1016/j.vaccine.2024.126513","DOIUrl":"10.1016/j.vaccine.2024.126513","url":null,"abstract":"<div><div>PreHevbrio® is a 3-antigen HBV vaccine (3-A-HBV) engineered to express the three HBV envelope proteins; the small ‘S' hepatitis B surface antigen (SHBs or HBsAg), the middle pre-S2 + HBsAg (MHBs) and the large PreS1 + PreS2 + HBsAg (LHBs) antigens. 3-A-HBV has been shown to induce superior and more durable antibody responses relative to a 1-A-HBV despite containing half the ‘S' antigen dose. To explain the mechanism(s) behind the high immunogenicity, the potential influence of mammalian glycosylation, HBs antigen conformation, anti-HBs epitope binding profiles and T-cell responses to the PreS antigens were investigated.</div><div>In this paper, we demonstrate that glycosylation status does not play a role in the increased immunogenicity of the 3-A-HBV, but that the 3-A-HBV particles are able to induce T cell responses to PreS1 and PreS2 antigens. Epitope mapping demonstrated that the 3-A-HBV particles are inherently more antigenic than 1-A-HBV particles, leading to quantitative differences in the anti-HBs antibody response. Further, we demonstrate that the T cell responses significantly correlate with the higher observed anti-HBs titers and may contribute to the higher and more durable anti-HBs titers.</div><div>This trial is registered at <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> (<span><span>NCT03393754</span><svg><path></path></svg></span>) and EudraCT (2017–001819-36).</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126513"},"PeriodicalIF":4.5,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634199","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 the Ad26/protein preF RSV vaccine in adults aged 18 to 59 years with and without at-risk comorbidities for severe respiratory syncytial virus disease: A phase 3, randomized, controlled, immunobridging trial","authors":"Archana Jastorff ,&nbsp;Efi Gymnopoulou ,&nbsp;Jose Salas ,&nbsp;Elizabeth Merrall ,&nbsp;Erik Buntinx ,&nbsp;Charlotte Martin ,&nbsp;Helena H. Askling ,&nbsp;Isabelle Schenkenberger ,&nbsp;Angela Cano Yuste ,&nbsp;William Smith ,&nbsp;Roberto Sotolongo ,&nbsp;Charlotte Von Engelhardt ,&nbsp;Arangassery Rosemary Bastian ,&nbsp;Christy Comeaux ,&nbsp;Nynke Ligtenberg ,&nbsp;Benoit Callendret ,&nbsp;Esther Heijnen","doi":"10.1016/j.vaccine.2024.126514","DOIUrl":"10.1016/j.vaccine.2024.126514","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory syncytial virus (RSV) causes a significant disease burden in adults with chronic comorbidities. Rates of severe RSV disease and death are as high, or higher in younger adults with risk factors than in healthy older adults in whom RSV vaccination is recommended. We conducted an immunobridging study using the Ad26/protein RSV preF vaccine, which previously demonstrated efficacy in adults aged ≥65 years to support extrapolation of efficacy demonstrated in an older population to younger adult populations at high risk of severe RSV disease.</div></div><div><h3>Methods</h3><div>This Phase 3 randomized, double-blind, placebo-controlled trial assessed the safety/tolerability and immunogenicity of Ad26/protein preF RSV in adults aged 18–59 years without (Cohort 1) and with (Cohort 2) chronic cardiac or pulmonary comorbidities, compared to adults aged ≥65 years (Cohort 3) in whom efficacy against RSV disease was demonstrated. Humoral and cellular immune responses were assessed at baseline, Days 15 and 183. Reactogenicity and safety were assessed in all participants.</div></div><div><h3>Results</h3><div>1118 participants were enrolled (Cohort 1: 387; Cohort 2: 388; Cohort 3: 343). Compared to adults aged ≥65 years RSV neutralizing antibody titers were non-inferior in adults aged 18–59 years, including those at high risk. Levels of pre-F A IgG antibodies and frequencies of RSV-F specific interferon-gamma T-cells increased by Day 15 post-vaccination, and remained above baseline for at least 6 months in all cohorts. Reactogenicity and safety were clinically acceptable but age-dependent, with higher rates of Grade 3 systemic adverse events in adults aged 18–59-years than adults ≥65 years.</div></div><div><h3>Conclusion</h3><div>Ad26/protein preF RSV vaccine induced robust humoral and cellular immune responses in adults aged 18–59 years with or without chronic cardiac or pulmonary comorbidities, of similar magnitude to responses in older adults, allowing inference of efficacy and protection against RSV-associated respiratory disease in this population. <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span> <span><span>NCT05070546</span><svg><path></path></svg></span></div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126514"},"PeriodicalIF":4.5,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142633835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}