To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 2022 Jul 28;13:920256. doi: 10.3389/fimmu.2022.920256. McLaughlin JM, Khan F, Begier E, Swerdlow DL, Jodar L, Falsey AR. PharmaVitae explores AbbVies prescription pharmaceutical performance and outlook over 201929. What's the Story with RSV? | Eureka blog government site. 2022 Feb 7;40(6):934-944. doi: 10.1016/j.vaccine.2021.12.043. 5 Ad26.RSV.preF : Respiratory syncytial virus (RSV) vaccines, LIST OF FIGURES Rsv A2 | ATCC | Bioz Adenovectors encoding RSV-F protein induce durable and mucosal - Nature Williams K, Bastian AR, Feldman RA, et al. 17/ Ad26.RSV.preF is a recombinant adenoserotype 26 vector (Ad26) vaccine Encodes for a full-length, stabilized pre-RSV-F protein expressed on the cell surface In clinical trials to assessprotection against #RSV infection & disease #MedTwitter #IDTwitter #IDMedEd. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Why Should I Register and Submit Results? The respiratory syncytial virus is preying on children and the elderly, but science could be closing in on solutions. In this phase 2a, double-blind, placebo-controlled study, 180 adults aged 60 years received Ad26.RSV.preF plus Fluarix on day 1 and placebo on day 29, or placebo plus Fluarix on day 1 and Ad26.RSV.preF on day 29 (control). Oddzial w Katowicach, Krakowskie Centrum Medyczne Sp. The results are compatible with simultaneous seasonal vaccination with both vaccines. A second adenovirus-based candidate in phase 2 trials in seropositive children is ChAd155-RSV . Johnson & Johnson is developing a replication-deficient adenovirus vector vaccine, Ad26.RSV.preF, which encodes a prefusion form of the respiratory syncytial virus (RSV) fusion (F) protein and is being developed for use in infants aged <24 months, as well as the elderly aged 60 years. Clinical trials registration: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Influenza Vaccine Strains [TimeFrame:28 days after first vaccination (Day 29)], Prefusion F protein (preF) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers [TimeFrame:28 days after first vaccination (Day 29)], Percentage of Participants with Solicited Local (INJECTION SITE) Adverse Events (AEs) for 7 Days After Each Vaccination [TimeFrame:Up to 7 days after each vaccination (Day 8 and Day 36)], Percentage of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination [TimeFrame:Up to 7 days after each vaccination (Day 8 and Day 36)], Percentage of Participants with Unsolicited AEs for 28 Days After Each Vaccination [TimeFrame:Up to 28 days after each vaccination (Day 29 and Day 57)], Percentage of Participants with Serious Adverse Events (SAEs) Until 6 Months After the Second Study Vaccination [TimeFrame:Up to 6 months after the second study vaccination (Day 211)], Percentage of Participants with Adverse Event of interest (AESI) Until 6 Months After the Second Study Vaccination [TimeFrame:Up to 6 months after the second study vaccination (Day 211)], Percentage of Participants with Seroconversion [TimeFrame:28 days after first vaccination (Day 29)], Percentage of Participants with Seroprotection [TimeFrame:28 days after first vaccination (Day 29)], Willing and able to adhere to the prohibitions and restrictions specified in this protocol, In the investigator's clinical judgment, the participant must be in stable health at the time of vaccination. Shi T, McAllister DA, OBrien KL, et al. -, Shi T, Denouel A, Tietjen AK, et al. . Higher scores indicating greater severity. PLoS Pathog. Yi H, Wang Q, Deng J, Li H, Zhang Y, Chen Z, Ji T, Liu W, Zheng X, Ma Q, Sun X, Zhang Y, Yu X, He M, Chen L, Feng Y. Virol Sin. Quadrivalent High-dose Influenza Vaccine will be administered as IM injection. Vaccines (Basel). doi: 10.1002/cti2.1345. z o.o. Safety and Immunogenicity of the Ad26.RSV.preF Investigational Vaccine Safety and Immunogenicity of the Ad26.RSV.preF Investigational Vaccine Coadministered With an Influenza Vaccine in Older Adults. Keywords: Janssen Announces Phase 2b Data Demonstrating its Investigational RSV Adenoviral vector-based platforms for developing effective vaccines to combat respiratory viral infections. Perceived discrimination has been linked to elevated inflammatory markers, such as C-reactive protein (CRP), which increases risk for worse cognitive functioning. government site. Michael Ison, MD MS on Twitter: "17/ Ad26.RSV.preF is a recombinant Participants will receive Ad26.RSV.preF-based vaccine and quadrivalent high dose influenza vaccine concomitantly on Day 1 and placebo on Day 29. Disclaimer, National Library of Medicine Oddzial we Wroclawiu, Synexus Helderberg Clinical Research Centre, Stanza Clinical Research Centre : Mamelodi, The Aurum Institute Rustenburg Clinical Research Site, Kaohsiung Medical University Chung-Ho Memorial Hospital, The Vaccine Trial Center(VTC), Faculty of Tropical Medicine, Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine, Synexus Midlands Clinical Research Centre, Synexus Lancashire Clinical Research Centre, Synexus Scotland Clinical Research Centre, Synexus Merseyside Clinical Research Centre, Synexus Manchester Clinical Research Center, Synexus Ltd., Thames Valley Clinical Research centre, Stockton on Tees, United Kingdom, TS19 8PE, Janssen Vaccines & Prevention B.V. Clinical Trial. 2020 Aug 17;222(6):979-988. doi: 10.1093/infdis/jiaa193. You have reached the maximum number of saved studies (100). Methods: At 28 days after the first vaccination, the upper confidence intervals of the hemagglutination inhibition antibody geometric mean ratio (control/coadministration) for all influenza strains were <2, demonstrating noninferiority. Epub 2021 Mar 25. Participants will receive placebo and quadrivalent high-dose influenza vaccine on Day 1 and Ad26.RSV.preF-based vaccine on Day 29. The vaccine is designed to stimulate both serum neutralizing antibody responses and strong T-cell responses to the F protein. The https:// ensures that you are connecting to the In a study reported by DeVincenzo et al., healthy adults aged 1850 were immunized with a recombinant adenoviral vector containing prefusion F (Ad26.RSV.preF).23 At day 28 post-vaccination, the RSV A IC50 GMT in the Ad26 vaccinated group was approximately 5-to 6-fold higher than baseline (267 versus 1589). API | ad26.rsv.pref Open Forum Infect Dis 2017; 4:ofw270. Schwarz TF, McPhee RA, Launay O, Leroux-Roels G, Talli J, Picciolato M, Gao F, Cai R, Nguyen TL, Dieussaert I, Miller JM, Schmidt AC. -. Bethesda, MD 20894, Web Policies 2019 Oct 22;220(11):1816-1825. doi: 10.1093/infdis/jiz395. bioRxiv on Twitter: "Combination Ad26.RSV.preF/RSV preF protein vaccine Clin Transl Immunology. Surprise! Pfizer jumps the queue and leaps into RSV vax contention as Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05071313. Perceived Everyday Discrimination and C- Reactive Protein Influence on doi: 10.1093/ofid/ofac300. Oddzial w Poznaniu, Synexus Polska Sp. Does a vaccine exist for RSV (Respiratory Syncytial Virus)? An official website of the United States government. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. View this study on Beta.ClinicalTrials.gov, Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. This document is a licensed product and is not to be reproduced or redistributed. Postchallenge, VL, RSV infections, and disease severity were lower in Ad26.RSV.preF (n = 27) vs placebo (n = 26) recipients: median VL area under the curve (AUC) quantitative real-time polymerase chain reaction: 0.0 vs 236.0 (P = .012; predefined primary endpoint); median VL-AUC quantitative culture: 0.0 vs 109; RSV infections 11 (40.7%) vs 17 (65.4%); median RSV AUC-CSS 35 vs 167, respectively. This study assessed coadministration of the investigational vaccine, Ad26.RSV.preF, an adenovirus serotype 26 (Ad26) vector encoding RSV F protein stabilized in its prefusion conformation (pre-F), with a seasonal influenza vaccine in older adults. PMC Vaccines (Basel). Beyfortus (nirsevimab) / AstraZeneca, Sanofi For general information, Learn About Clinical Studies. eCollection 2021. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Federal government websites often end in .gov or .mil. PRIME PubMed | Phase 1 Safety and Immunogenicity Study of a Respiratory Percentage of participants with RT-PCR confirmed RSV-mediated ARI will be reported. Ad26.RSV.preF is now in phase 2 trials in adults and 12-24-month-old RSV seropositive toddlers (NCT03303625) . Participants will receive a single IM injection of matching placebo. 2022 Sep 21;35(3):e0000821. Clinical trials registration: 8600 Rockville Pike Ad26.RSV.preF. The immunogenicity and safety of respiratory syncytial virus vaccines in development: A systematic review. | Find, read and cite all the research . There is no approved treatment for respiratory syncytial virus (RSV), and preventative therapies are limited to infants and children at high risk of severe RSV infections 1. As preF is non-functional, RSV-preFCT was amplified in a production line expressing a functional substitute, and . This study assessed the potential of Ad26.RSV.preF to protect against RSV infection and disease in an RSV human challenge model. Balixafortide (Polyphor) is a synthetic cyclopeptide derived from polyphemusin that inhibits C-X-C motif chemokine receptor 4 (CXCR4), a G-protein coupled receptor that exclusively binds to its ligand, stromal cell-derived factor-1 (SDF-1). 2022 Aug 26;226(3):396-406. doi: 10.1093/infdis/jiab003. Janssen to Showcase Progress on Respiratory Syncytial Virus (RSV A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Phase 1 safety and immunogenicity study of a respiratory syncytial virus vaccine with an adenovirus 26 vector encoding prefusion F (Ad26.RSV.preF) in . Vaccines for pregnant women and elderly which are in phase III clinical studies target people with pre-existing natural immunity against RSV. The site is secure. 7 Table 2: Ad26.RSV.preF ongoing Phase I/II clinical trials in RSV vaccination Respiratory syncytial virus (RSV) and influenza cause significant disease burden in older adults. Vaccines and Related Biological Products Committee May 17, 2017 Meeting Participants will be instructed on how to note signs and symptoms in the participant diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for these events. Inactivated split-virion seasonal influenza vaccine (Fluarix): a review of its use in the prevention of seasonal influenza in adults and the elderly. Respiratory syncytial virus: from pathogenesis to potential therapeutic You have reached the maximum number of saved studies (100). Sadoff J, De Paepe E, Haazen W, Omoruyi E, Bastian AR, Comeaux C, Heijnen E, Strout C, Schuitemaker H, Callendret B. J Infect Dis. respiratory syncytial virus (rsv) is a highly prevalent, very contagious respiratory infection and a leading cause of bronchitis and pneumonia, affecting more than 64 million people each year worldwide. N Engl J Med 2005; 352:174959. This study assessed the potential of Ad26.RSV.preF to protect against RSV infection and disease in an RSV human challenge model. (Clinical Trial), A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older, Experimental: Group 1: Respiratory Syncytial Virus (RSV) vaccine, 60 Years and older (Adult, Older Adult), Birmingham, Alabama, United States, 35205, Birmingham, Alabama, United States, 35211, Birmingham, Alabama, United States, 35216, Huntsville, Alabama, United States, 35802, Baptist Health Center for Clinical Research, Little Rock, Arkansas, United States, 72205, Anaheim, California, United States, 92801, Banning, California, United States, 92220, Canoga Park, California, United States, 91303, Cerritos, California, United States, 90703, Chula Vista, California, United States, 919111, La Mesa, California, United States, 91942, Redding, California, United States, 96001, San Diego, California, United States, 92103-6204, San Diego, California, United States, 92108, Spring Valley, California, United States, 91978, Fort Collins, Colorado, United States, 80528, Wheat Ridge, Colorado, United States, 80033, Clearwater, Florida, United States, 33761, Clinical Research of South Florida, an AMR Company, Coral Gables, Florida, United States, 33134, AMR Fort Myers Clinical Physiology Associates, an AMR company, Fort Myers, Florida, United States, 33912, Velocity Clinical Research, Hallandale Beach, Hallandale Beach, Florida, United States, 33009, Jacksonville, Florida, United States, 32205, Jacksonville Center For Clinical Research, Jacksonville, Florida, United States, 32216, Lake Worth, Florida, United States, 33461, North Miami Beach, Florida, United States, 33162, North Miami, Florida, United States, 33161, Pinellas Park, Florida, United States, 33781, Port Orange, Florida, United States, 32127, Saint Petersburg, Florida, United States, 33709, West Palm Beach, Florida, United States, 33409, Stockbridge, Georgia, United States, 30281, Champaign, Illinois, United States, 61822, Evansville, Indiana, United States, 47714, The South Bend Clinic Center for Research, South Bend, Indiana, United States, 46617-2808, Valparaiso, Indiana, United States, 46383, West Des Moines, Iowa, United States, 50266. 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