Alphavirus

First Human Clinical Study to Assess U.S. Department of Defense DNA Vaccine Candidate against Venezuelan Equine Encephalitis Delivered with PharmaJet Precision Delivery Systems.

Retrieved on: 
Thursday, November 16, 2023
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The Phase 1 study, sponsored by PharmaJet, aims to identify the optimal dose, vaccination schedule and delivery system most suitable for use in subsequent broader clinical evaluations of the VEE DNA vaccine candidate.

Key Points: 
  • The Phase 1 study, sponsored by PharmaJet, aims to identify the optimal dose, vaccination schedule and delivery system most suitable for use in subsequent broader clinical evaluations of the VEE DNA vaccine candidate.
  • The VEE DNA vaccine candidate is being evaluated as part of a multi-year agreement between PharmaJet and the Joint Science and Technology Office of the U.S. Defense Threat Reduction Agency (DTRA) .
  • The study, in collaboration with USAMRIID, aims to further advance the clinical assessment of the vaccine with the PharmaJet Precision Delivery Systems: Tropis Intradermal (ID) and Stratis Intramuscular (IM).
  • The PharmaJet Precision Delivery Systems are optimized for field use and have also shown immunogenicity levels higher than with needle-syringe.

PharmaJet Announces U.S. Government Award Expansion to Clinically Assess a DNA Vaccine Combined with its Systems

Retrieved on: 
Tuesday, April 18, 2023
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The expansion award, worth over $4 million, will be used to further advance the clinical assessment of its Venezuelan Equine Encephalitis Virus (VEEV) DNA candidate vaccine in combination with either Tropis Intradermal (ID) or Stratis Intramuscular (IM) Systems.

Key Points: 
  • The expansion award, worth over $4 million, will be used to further advance the clinical assessment of its Venezuelan Equine Encephalitis Virus (VEEV) DNA candidate vaccine in combination with either Tropis Intradermal (ID) or Stratis Intramuscular (IM) Systems.
  • Venezuelan Equine Encephalitis Virus is an alphavirus that causes encephalitis and potential mortality in infected humans and equines.
  • It is listed as a potential biothreat agent with no approved human vaccine or therapeutic currently available.
  • PharmaJet is working with a contract manufacturer to produce the cGMP VEEV plasmid DNA vaccine and is preparing the Investigational New Drug (IND) application.

Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Monday, December 5, 2022
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The antibody persistence trial enrolled 363 healthy adult participants and followed them from month 6 after vaccination to month 12.

Key Points: 
  • The antibody persistence trial enrolled 363 healthy adult participants and followed them from month 6 after vaccination to month 12.
  • These antibody levels confirm the antibody persistence profile observed in an earlier study3.
  • The antibody persistence was similar in older adults aged ≥65 years, who retained neutralizing antibody titers comparable to younger adults throughout the follow-up.
  • VLA1553 is a live-attenuated, single dose vaccine candidate targeting the chikungunya virus, which has spread to over 100 countries.

Emergex Generates Chikungunya Ligandome, a Milestone in the Development of its T cell Adaptive Vaccine

Retrieved on: 
Monday, November 28, 2022
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Abingdon, Oxon, UK, 28 November 2022 Emergex Vaccines Holding Limited (Emergex), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines, announces today that it has generated a Chikungunya (CHIKV) ligandome, the first major milestone in the development of Emergexs CD8+ T cell CHIKV Adaptive Vaccine candidate.

Key Points: 
  • Abingdon, Oxon, UK, 28 November 2022 Emergex Vaccines Holding Limited (Emergex), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines, announces today that it has generated a Chikungunya (CHIKV) ligandome, the first major milestone in the development of Emergexs CD8+ T cell CHIKV Adaptive Vaccine candidate.
  • The library of CHIKV ligandome peptides identified by Emergex will now enter the next phase of development.
  • Laurens Rademacher, Chief Technology Officer at Emergex commented: The ligandome identified allows the addition of a Chikungunya vaccine candidate to Emergexs pipeline.
  • The ligandome library which contains viral and self MHC class I peptides has been established successfully by using the Emergex proprietary vaccine development platform, which provides a rational basis for CD8+ T cell vaccine development.

Emergent BioSolutions Presents Data from Phase 2 Study Evaluating Safety and Immunogenicity of Chikungunya Vaccine Candidate in Prior Recipients of Other Alphavirus Vaccines

Retrieved on: 
Tuesday, November 1, 2022
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This Phase 2 parallel group, age- and gender-matched, open-label study evaluating the safety and immunogenicity of an adjuvanted CHIKV VLP vaccine candidate in prior recipients of experimental alphavirus vaccines, in comparison to a cohort of alphavirus vaccine-nave individuals, enrolled 60 healthy adults at two U.S. sites.

Key Points: 
  • This Phase 2 parallel group, age- and gender-matched, open-label study evaluating the safety and immunogenicity of an adjuvanted CHIKV VLP vaccine candidate in prior recipients of experimental alphavirus vaccines, in comparison to a cohort of alphavirus vaccine-nave individuals, enrolled 60 healthy adults at two U.S. sites.
  • A higher percentage of prior alphavirus vaccine candidate recipients had a four-fold rise on study day 8 than the alphavirus vaccine-nave group.
  • In addition to the oral presentation on the chikungunya vaccine candidate, Emergent has poster presentations on its smallpox vaccine, cholera vaccine, and Lassa fever vaccine candidate.
  • Emergent BioSolutions CHIKV VLP chikungunya virus vaccine candidate is a single dose VLP-based vaccine in clinical development for active immunization against chikungunya disease.

Valneva Initiates Rolling Submission of FDA Biologics License Application for its Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Thursday, August 18, 2022
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Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease.

Key Points: 
  • Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease.
  • This rolling BLA submission is part of the accelerated approval pathway agreed upon with the FDA in 20204.
  • Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
  • VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 120 countries.

Valneva to Present on its Single-Shot Chikungunya Vaccine Candidate, Host Symposium at NECTM8

Retrieved on: 
Tuesday, June 7, 2022
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Vera Brger, Director Clinical Strategy at Valneva, will present an abstract on the clinical development of VLA1553.

Key Points: 
  • Vera Brger, Director Clinical Strategy at Valneva, will present an abstract on the clinical development of VLA1553.
  • In addition, Valneva will host a symposium on Friday, June 10, 2022 at 12:30 p.m. CEST.
  • Valneva, a gold sponsor of NECTM8, will have a display in the exhibit area at booth #8.
  • VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 120 countries.

Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Wednesday, May 25, 2022
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Saint Herblain (France), May 25, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the successful completion of the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553.

Key Points: 
  • Saint Herblain (France), May 25, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the successful completion of the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553.
  • Chikungunya is a major, growing and unmet public health threat, yet no vaccine or specific treatment is currently available to prevent this debilitating disease.
  • Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.

Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Tuesday, March 8, 2022
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Saint Herblain (France), March 8, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the successful completion of the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553.

Key Points: 
  • Saint Herblain (France), March 8, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the successful completion of the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553.
  • Juan Carlos Jaramillo, M.D, Chief Medical Officer of Valneva commented, These final pivotal Phase 3 results confirm the compelling profile of our single-shot vaccine candidate across all age groups.
  • VLA1553 is a live-attenuated, single dose vaccine candidate targeting the chikungunya virus, which has spread to over 120 countries.
  • It is a prospective, double-blinded, multicenter, randomized, pivotal Phase 3 trial evaluating 4,115 participants aged 18 years or above.

Emergex Awarded £490,525 UK Aid Grant by the Department of Health and Social Care to Advance Synthetic T cell Vaccine Candidate for Chikungunya Virus

Retrieved on: 
Tuesday, February 22, 2022
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The grant will cover the cost of generating a Chikungunya vaccine prototype.

Key Points: 
  • The grant will cover the cost of generating a Chikungunya vaccine prototype.
  • The project covers the identification of novel Chikungunya peptide epitopes (collectively constituting the ligandome), synthesis of a vaccine candidate and testing in in vitro efficacy models.
  • The funding, administered through UK Aid (Official Development Assistance) funding, was awarded following a Small Business Research Initiative (SBRI) competition funded by the DHSCs UK Vaccine Network (UKVN), delivered through Innovate UK.
  • Emergex will generate a fully synthetic Priming CD8+ T cell Adaptive Vaccine candidate by targeting regions of the Chikungunya virus that are common amongst all Togaviridae viruses.