bnt163 herpes vaccine

Editors Note: The University of Pennsylvania has licensed some intellectual property related to the BNT163 vaccine candidate to BioNTech. A Clinical Trial in Healthy Volunteers to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Unauthorized use of these marks is strictly prohibited. Print 2019 May 1. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05432583. Front Cell Infect Microbiol. Kids With Rare Diseases Get Mitochondria From Their Mothers Federal government websites often end in .gov or .mil. 2021 Dec 1;131(23):e152310. For non-personal use or to order multiple copies, please contact Up to 95% of the global population are estimated to be infected by herpes with most of the infections remaining asymptomatic, but symptoms of herpes include painful blisters or ulcers that can recur over time. The study consists of a first dose escalation part that will focus on safety evaluations and assess the optimal dose-response in various dose levels. We aim to induce a broad immune response which is directed against multiple antigens of the virus and mobilizes various immune effectors to support virus neutralization and clearance., Copyright - Unless otherwise stated all contents of this web site are 2023 - William Reed Ltd - All Rights Reserved - Full details for the use of materials on this site can be found in the Terms & Conditions, Related topics Talk with your doctor and family members or friends about deciding to join a study. The second part of the trial is designed to expand the safety characterization for the selected dosing of BNT163 for a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and BNT163-induced immune responses. The World Health Organizationestimatesthe number of people aged 15-49 suffering from HSV-2 infection at around 491 million. Nevertheless, a previous HSV vaccine candidate did have partial success in preventing genital herpes and HSV acquisition and another immunotherapeutic candidate reduced viral shedding and recurrent lesions, inspiring further research. Currently available HSV therapies only reduce the severity and frequency of symptoms. According to the World Health Organization, approximately 500 million people globally are estimated to be affected by genital infections caused by HSV-2. Current or history of symptomatic genital herpes infections. Part B of the trial will expand the safety characterization for a BNT163 dose selected based on Part A data and enable a more comprehensive assessment of the impact of pre-existing immunity to Herpes Simplex Virus (HSV)-1 and -2 on the safety and BNT163-induced immune responses after one selected (higher) dose of BNT163 than could be done during the dose escalation performed in Part A. Anti-viral ribonucleic acid (RNA) vaccine for active immunization against HSV-2 administered as intramuscular injection. MAINZ, Germany, December 21, 2022 BioNTech SE (Nasdaq: BNTX, BioNTech or the "Company) today announced that the first subject was dosed in a first-in-human Phase 1 clinical research study with BNT163, a herpes simplex virus (HSV) vaccine candidate for the prevention of genital lesions caused by HSV-2 and potentially HSV-1. The study consists of a first dose escalation part that will focus on safety evaluations and assess the optimal dose-response in various dose levels. (Molteni, 12/21), Hospital Investigated for Allegedly Denying an Emergency Abortion After Patient's Water Broke, Medicare Fines for High Hospital Readmissions Drop, but Nearly 2,300 Facilities Are Still Penalized, This Open Enrollment Season, Look Out for Health Insurance That Seems Too Good to Be True, What Looks Like Pot, Acts Like Pot, but Is Legal Nearly Everywhere? The mRNA vaccine encodes three HSV-2 glycoproteins with the aim of helping to prevent HSV cellular entry and spread, as well as counteract the immunosuppressive properties of HSVs. The incorporation of adjuvants of the vaccine candidates in the past, may account for their partial efficacy. Dec 21 (Reuters) BioNtech(22UAy.DE)has dosed the first patient with its BNT163 herpes vaccine candidate designed to prevent genital lesions as part of a first-in-human Phase 1 clinical research study, the German vaccine maker said on Wednesday. 2023 Predictions: the next chapter of the digital-first, artificial intelligence U.S. Centers for Disease Control and Prevention (CDC). BNT163 is based on three non-infectious mRNA-encoded HSV-2 glycoproteins. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The SARS-CoV-2 vaccination is one of the major strategies against the COVID-19 pandemic. KHN is an editorially independent program of KFF (Kaiser Family Foundation). An Overview of Nanocarrier-Based Adjuvants for Vaccine Delivery. Furthermore, HSV-2 infection increases the risk of acquiring HIV infections by approximately three-fold, and co-infections with both HIV and HSV-2 increase the likelihood of transmitting HIV to others, according to the WHO. 2023 Feb 5;15(2):439. doi: 10.3390/v15020439. (Court, 12/21), Stat: } Here's How Much Marjorie Taylor Greene Has Lost On Her Trump SPAC Investment - Digital World Acq (NASDAQ: Don't miss real-time alerts on your stocks - join Benzinga Pro for free! We appreciate all forms of engagement from our readers and listeners, and welcome your support. Any existing condition which may affect vaccine injection and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. About Herpes Simplex VirusHerpes Simplex Virus-1 (HSV-1) and Herpes Simplex Virus-2 (HSV-2) cause two highly prevalent viral infections globally. Trump tax audits required by IRS were delayed: panel 1 hour ago 2021 May 26;11:649722. doi: 10.3389/fcimb.2021.649722. The trial will evaluate the safety, tolerability, and immunogenicity of BNT163. BioNTechs placebo-controlled, observer blinded, dose-escalation Phase 1 trial is expected to enroll around 100 healthy volunteers aged 18 to 55 years without current or history of symptomatic genital herpes infections in the U.S. BNT163 is the first candidate from BioNTech's infectious disease mRNA vaccine collaboration with the University of Pennsylvania to enter the clinic The program is part of BioNTech's strategy to. The World Health Organization (WHO), in a revised position paper, has updated its human papillomavirus (HPV) vaccine recommendations to include a single-dose schedule, an effort to expand vaccination amid a worrying global decline in coverage. Volunteers with oral herpes or herpetic whitlow will not be excluded. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. BioNtech has dosed the first patient with its BNT163 herpes vaccine candidate designed to prevent genital lesions as part of a first-in-human Phase 1 clinical research study, the German vaccine. All rights reserved. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). J Clin Invest. Protective immunity to genital herpes simplex virus type 1 and type 2 provided by self-adjuvanting lipopeptides that drive dendritic cell maturation and elicit a polarized Th1 immune response. Information provided by (Responsible Party): This exploratory trial will have two parts. vOut = vOut.toLowerCase(); Price Action:BNTX shares are up 1.68% at $175.60 on the last check Wednesday. Received allergy treatment with antigen injections within 28 days before first IMP administration or that are scheduled within 14 days after Visit 1. HSV-2 neutralizing antibody titers. Ayoub HH, Amara I, Awad SF, Omori R, Chemaitelly H, Abu-Raddad LJ. For more than a month, Shane Anthony, a 57-year-old auto mechanic, hasnt been able to get his diabetes medication. BioNTech SE. return vOut; Li X, Wang J, Mou T, Gao Y, Wang L, Fan S, Xu X, Jiang G, Cui P, Xu X, Duan S, Zhang J, Li D, Liao Y, Yu L, Zhao H, Lu M, Zhu H, Gu R, Zhang Y, Dong W, Li Q. Truong NR, Smith JB, Sandgren KJ, Cunningham AL. BioNTech expects to enrol 100 people between ages 18 and 55 for its Phase 1 trial of the drug, the firm added. Choosing to participate in a study is an important personal decision. HSV-1 is mainly transmitted by oral contact and causes lesions around the mouth but in some cases can also lead to genital infections and respective lesions. Both viruses are highly contagious and can also be transmitted during childbirth. While Part A will focus on the safety evaluations, vaccine-induced immune responses (specifically neutralizing antibodies) will also be analyzed to assess if there is a dose-response. Before As part of our strategy, we have announced that the first subject was dosed in a first-in-human Phase 1 clinical trial with BNT163, a prophylactic herpes simplex virus-2 vaccine candidate. Meanwhile, Cohen and his team are working on developing herpes vaccines, and numerous studies have looked at different herpes vaccine candidates. To ensure this doesnt happen in the future, please enable Javascript and cookies in your browser. Related tags dataLayerNews.related_tags = sanitize_gpt_value2("BioNTech, mRNA, Vaccines"); According to the World Health Organization (WHO), approximately 500 million people globally are estimated to be affected by genital infections caused by HSV-2,1 with painful genital lesions, an increased risk for meningitis and high levels of emotional distress. It is the first result of the research collaboration established in 2018 between the University of Pennsylvania and BioNTech aimed at developing novel mRNA vaccine candidates for the prevention and treatment of various infectious diseases. ! Any screening hematology and/or blood chemistry laboratory value that meets the definition of a Grade 1 abnormality at Visit 0. o Note: With the exception of direct bilirubin, participants with any stable Grade 1 abnormalities (according to the toxicity grading scale) may be considered eligible at the discretion of the investigator. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 21-Dec-2022 at 21:26 GMT. No vaccine has been approved for prevention of genital lesions caused by HSV to date. -- First-in-human study aims to evaluate the safety and immunogenicity of prophylactic herpes virus vaccine candidate BNT163 -- BNT163 is the first candidate from BioNTech's infectious disease . VOCBP who agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting at Visit 0 and continuously until 60 days after receiving the last trial treatment. Cuando utilizas nuestros sitios y aplicaciones, usamos. Licensed live attenuated vaccines (e.g., influenza vaccines) are allowed at least 28 days before or 28 days after any IMP administration. As controls, a sub-cohort of similar HCW, who are recruited to the Sheba COVID Cohort study (IRB 8008-20) and are followed monthly with . 2021 Mar 27;13(4):455. doi: 10.3390/pharmaceutics13040455. And over the next 2 billion or so years, that bacteria evolved to be the mitochondria that power nearly every cell in the human body. 2023 Kaiser Family Foundation. For a discussion of these and other risks and uncertainties, see BioNTechs Quarterly Report as Form 6-K for the quarter ended September 30, 2022, filed with the SEC on November 7, 2022, which is available on the SECs website at www.sec.gov. These volunteers will recieve a 4th dose (30 microgram) of the BNT162b2 vaccine. We aim to induce a broad immune response which is directed against multiple antigens of the virus and mobilizes various. The company expects to launch phase 1 clinical trials before the end of 2022. The trial will evaluate the safety, tolerability and immunogenicity of the prophylactic mRNA candidate in preventing genital lesions caused by the viruses. Bettahi I, Zhang X, Afifi RE, BenMohamed L. Viral Immunol. }); The trial will evaluate the safety, tolerability and immunogenicity of the prophylactic mRNA candidate in preventing genital lesions caused by the viruses. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Vaccines Petkar KC, Patil SM, Chavhan SS, Kaneko K, Sawant KK, Kunda NK, Saleem IY. BioNtech has dosed the first patient with its BNT163 herpes vaccine candidate designed to prevent genital lesions as part of a first-in-human Phase 1 clinical research study, the German vaccine maker said on Wednesday. BioNTech SE(NASDAQ: BNTX) has dosed in a first-in-human Phase 1 clinical research study with BNT163, a herpes simplex virus (HSV) vaccine candidate for the prevention of genital lesionscaused by HSV-2 and potentially HSV-1. Bookshelf California Wants To Revoke A CVS Mail-Order License For Illegally Filling Opioid And ADHD Prescriptions, Stat: (Clinical Trial), Triple (Participant, Care Provider, Investigator), Phase I, Randomized, Observer-blinded, Placebo-controlled, 2-part, Dose Escalation and Expanded Safety Evaluation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Prophylactic Vaccine for the Prevention of Genital Lesions Caused by Herpes Simplex Virus (HSV)-2 and Potentially HSV-1, Contact: BioNTech clinical trials patient information, Raleigh, North Carolina, United States, 27609, Wilmington, North Carolina, United States, 28401. Accessibility This program is part of our strategy to help address diseases with a high unmet medical need and of global health relevance by combining our new technologies such as mRNA and our expertise in immune engineering, said Prof. zlem Treci, M.D., Chief Medical Officer and Co-Founder of BioNTech. doi: 10.1093/ofid/ofab218. BioNTech said that according to the World Health Organization (WHO), ~500M people globally are estimated to be affected by genital infections caused by HSV-2 with painful genital lesions, an increased risk for meningitis and high levels of emotional distress. Would you like email updates of new search results? Given a decrease in the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers three months following the second BNT162b2 dose, healthcare workers got a third booster dose after six months of completing the original scheme. Moreover, HSV-2 infection increases the risk of acquiring HIV infections by approximately three-fold, and co-infections with both HIV and HSV-2 increase the likelihood of transmitting HIV to others according to the WHO.2 No vaccine has been approved for prevention of genital lesions caused by HSV to date. December 21, 2022 06:45 ET Here we review the history of vaccines for HSV, those in development and compare them to successful vaccines for chicken pox or herpes zoster. 2020 Jan 3;38(1):79-89. doi: 10.1016/j.vaccine.2019.09.090. Up to 95% of the global population are estimated to be infected by herpes with most of the infections remaining asymptomatic, but symptoms of herpes include painful blisters or ulcers that can recur over time.3 HSV-1 is mainly transmitted by oral contact and causes lesions around the mouth but in some cases can also lead to genital infections and respective lesions. We aim to induce a broad immune response which is directed against multiple antigens of the virus and mobilizes various immune effectors to support virus neutralization and clearance," said BioNTech Co-Founder and Chief Medical Officer zlem Treci. Vaccine. doi: 10.1172/JCI152310. The University of Pennsylvania receives sponsored research funding from BioNTech related to preclinical development of the BNT163 vaccine candidate. Volunteers of childbearing potential (VOCBP): negative serum beta human chorionic gonadotropin (-HCG) pregnancy test at Visit 0 and negative urine pregnancy test prior to each investigational medicinal product (IMP) administration and at the end of the trial. Introduction: Concerns were raised over an increase in Bell's palsy, herpes simplex and herpes zoster after BNT162b2 vaccination, all are manifestations of herpesviruses reactivation. (Silverman, 12/21), Stat: 21-Dec-2022 Benzinga does not provide investment advice. If you have an ad-blocker enabled you may be blocked from proceeding. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Prevention of genital lesions caused by herpes simplex virus-2, Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose [TimeFrame:Up to 7 days after each dose], Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each dose [TimeFrame:Up to 7 days after each dose], Percentage of participants with at least one unsolicited adverse event (AE) occurring up to 28 days after each dose [TimeFrame:From Day 1 up to Day 197], Percentage of participants in each cohort with at least one serious adverse event, or adverse event of special interest, or medically attended adverse event occurring up to 24 weeks post-Dose 3 [TimeFrame:From Day 1 up to Day 337], Frequency of unsolicited AEs occurring up to 28 days after each dose [TimeFrame:From Day 1 up to Day 197], Percentage of unsolicited AEs occurring up to 28 days after each dose [TimeFrame:From Day 1 up to Day 197], Geometric mean titer (GMT) at each time point [TimeFrame:From Day 1 up to Day 337], Geometric mean fold (GMF) change from baseline of neutralizing and binding antibody titers to each time point after vaccination [TimeFrame:From Day 1 up to Day 337], Percentage of participants with seroconversion defined as a minimum of 4-fold increase from baseline of neutralizing and binding antibody titers to each subsequent time point after vaccination [TimeFrame:From Day 1 up to Day 337]. 2019 Mar 6;10:373. doi: 10.3389/fimmu.2019.00373. 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