H5N1 clinical trials

Longhorn’s Universal Influenza Vaccine Candidate LHNVD-105 Shows Promising Strain Coverage

Retrieved on: 
Tuesday, July 20, 2021

We believe that a successful universal influenza vaccine will need to combine state of the art adjuvant technologies and highly conserved influenza epitopes to optimize the host immune response.

Key Points: 
  • We believe that a successful universal influenza vaccine will need to combine state of the art adjuvant technologies and highly conserved influenza epitopes to optimize the host immune response.
  • Over the last 15 years, Longhorn has been developing and optimizing its universal influenza vaccine based on a patented composite peptide platform.
  • In doing so, Longhorns universal influenza vaccine can provide multiple pathways to respond to different strains, making it harder for these strains to escape the scope of the vaccine.
  • For more information about Longhorns universal influenza vaccine candidate LHNVD-105, please visit https://lhnvd.com .

Altimmune Announces Update on AdCOVID™ Phase 1 Clinical Trial

Retrieved on: 
Tuesday, June 29, 2021

The Company also provided an update on its T-COVID Phase 1/2 clinical trial to evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19.

Key Points: 
  • The Company also provided an update on its T-COVID Phase 1/2 clinical trial to evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19.
  • The Phase 1 AdCOVID clinical trial is evaluating the safety and immunogenicity of the intranasally administered vaccine candidate in approximately 80 healthy adult volunteers between the ages of 18 and 55.
  • Based on these data, and in view of the highly competitive COVID-19 vaccine landscape, Altimmune is discontinuing further development of AdCOVID beyond the completion of this Phase 1 trial.
  • The immune response to AdCOVID was inferior to that seen in our NasoVAX influenza vaccine trial, commented Scot Roberts, PhD, Chief Scientific Officer at Altimmune.

Sanofi and Translate Bio Initiate Phase 1 Clinical Trial of mRNA Influenza Vaccine

Retrieved on: 
Tuesday, June 22, 2021

The first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of influenza vaccines.

Key Points: 
  • The first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of influenza vaccines.
  • We are pleased to have this second mRNA vaccine program underway with our partner Sanofi Pasteur, said Ronald Renaud, chief executive officer, Translate Bio.
  • We look forward to evaluating the potential of these mRNA influenza vaccine candidates in this Phase 1 clinical trial.
  • Sanofi and Translate Bio have developed and will evaluate two formulations of the vaccine (MRT5400 and MRT5401) in the Phase 1 influenza mRNA vaccine clinical trial.

Icosavax Initiates Phase 1/2 Trial of COVID-19 VLP Vaccine Candidate

Retrieved on: 
Tuesday, June 8, 2021

We are pleased to be working with Seqirus to evaluate MF59 in combination with IVX-411, our COVID-19 VLP vaccine candidate.

Key Points: 
  • We are pleased to be working with Seqirus to evaluate MF59 in combination with IVX-411, our COVID-19 VLP vaccine candidate.
  • The Phase 1/2 clinical trial is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the safety and immunogenicity of adjuvanted and unadjuvanted IVX-411.
  • The Phase 2 part of the trial will enroll SARS-CoV-2 seropositive adults who have completed a vaccine regimen using a licensed COVID-19 vaccine.
  • Icosavax is advancing VLP vaccine candidates against respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and SARS-CoV-2 (COVID-19).

Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

Retrieved on: 
Wednesday, April 14, 2021

"The potential utility of pooling public health resources, including all available vaccines, could help us get ahead of an evolving virus.

Key Points: 
  • "The potential utility of pooling public health resources, including all available vaccines, could help us get ahead of an evolving virus.
  • "\nCom-COV2 will include 1050 adults 50 years of age or older who received their first vaccination during the prior 8-12 weeks.
  • Volunteer study participants will receive one of four different vaccines as a second dose, 350 of whom will be administered NVX-CoV2373.
  • "\nUnder the protocol , which is a designed as a non-inferiority study, participants will be followed for reactogenicity (safety) and immune responses.

Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

Retrieved on: 
Wednesday, April 14, 2021

"The potential utility of pooling public health resources, including all available vaccines, could help us get ahead of an evolving virus.

Key Points: 
  • "The potential utility of pooling public health resources, including all available vaccines, could help us get ahead of an evolving virus.
  • "\nCom-COV2 will include 1050 adults 50 years of age or older who received their first vaccination during the prior 8-12 weeks.
  • Volunteer study participants will receive one of four different vaccines as a second dose, 350 of whom will be administered NVX-CoV2373.
  • "\nUnder the protocol , which is a designed as a non-inferiority study, participants will be followed for reactogenicity (safety) and immune responses.

Novavax CEO Stan Erck to Participate in Longwood Healthcare Leaders Meeting

Retrieved on: 
Monday, April 5, 2021

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases.

Key Points: 
  • Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases.
  • Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
  • Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
  • Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements.

Gritstone Announces First Person Dosed with its Second-Generation COVID-19 Vaccine in Phase 1 Study Conducted and Supported by NIAID/IDCRC

Retrieved on: 
Monday, March 29, 2021

The Phase 1 study (clinicaltrials.gov identifier: NCT04776317 ) is supported by the National Institute of Allergy and Infectious Diseases (NIAID) and is being conducted through their Infectious Diseases Clinical Research Consortium (IDCRC).

Key Points: 
  • The Phase 1 study (clinicaltrials.gov identifier: NCT04776317 ) is supported by the National Institute of Allergy and Infectious Diseases (NIAID) and is being conducted through their Infectious Diseases Clinical Research Consortium (IDCRC).
  • We are also exploring the potential to use a lower dose of the self-amplifying mRNA vaccine, which could enable more patients to be treated with a given amount of manufactured vaccine.
  • The Phase 1 clinical trial is a multicenter, open-label, dose- and age-escalation study to examine the immunogenicity and safety of Gritstones CORAL COVID-19 vaccine in healthy adult volunteers.
  • Certain non-Spike genes, some of which are included in our vaccine, tend to be conserved in coronaviruses over time and across variants.

Clover Biopharmaceuticals and Dynavax Announce First Participants Dosed in SPECTRA, a Global Phase 2/3 Clinical Trial for Adjuvanted S-Trimer COVID-19 Vaccine Candidate

Retrieved on: 
Wednesday, March 24, 2021

The global Phase 2/3 trial is a double-blind, randomized, controlled study of the adjuvanted S-Trimer COVID-19 vaccine candidate in a two-dose regimen, given 21 days apart.

Key Points: 
  • The global Phase 2/3 trial is a double-blind, randomized, controlled study of the adjuvanted S-Trimer COVID-19 vaccine candidate in a two-dose regimen, given 21 days apart.
  • Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals, said, "Dosing the first participants in SPECTRA marks another significant milestone in our journey to develop a COVID-19 vaccine.
  • Ryan Spencer , Chief Executive Officer of Dynavax, commented, "We are excited to see the first participants dosed in SPECTRA, providing an opportunity for Clover's protein subunit vaccine candidate adjuvanted with CpG 1018 to demonstrate safety and efficacy.
  • We are proud to be collaborating with Clover on the development of this vaccine for COVID-19 and committed to supporting Clover in making the vaccine available globally."

Sanofi and Translate Bio Initiate Phase 1/2 Clinical Trial of mRNA COVID-19 Vaccine Candidate

Retrieved on: 
Friday, March 12, 2021

We have made important progress toward developing mRNA vaccine candidates for infectious diseases through our collaboration with our partner Sanofi Pasteur, said Ronald Renaud, Chief Executive Officer of Translate Bio.

Key Points: 
  • We have made important progress toward developing mRNA vaccine candidates for infectious diseases through our collaboration with our partner Sanofi Pasteur, said Ronald Renaud, Chief Executive Officer of Translate Bio.
  • The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20C storage temperature for late-stage clinical trials and at launch.
  • The Phase 1/2 clinical trial is a randomized, double blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of MRT5500, a COVID-19 vaccine candidate.
  • Translate Bio is also pursuing the development of mRNA vaccines for infectious diseases under a collaboration with Sanofi Pasteur.