phase 2 clinical Balanced News

NIH funds new influenza research network


var addthis_config ={ ui_508_compliant: true}A Colorized structure of a prototype for a universal flu vaccine, known as H1ssF_3928, which is being evaluated as part of a Phase 1 clinical trial at the NIH Clinical Center in Bethesda, MD. The vaccine nanoparticle, designed by Jeffrey Boyington (VRC), is a hybrid of a protein scaffold (blue) and eight influenza hemagglutinin proteins arrayed on the surface (yellow). The hemagglutinin protein waNIAIDWhatThe National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has established a network of research sites to study the natural history, transmission and pathogenesis of influenza and provide an international research infrastructure to address influenza outbreaks. The program, called the Centers of Excellence for Influenza Research and Response (CEIRR), is expected to be supported for seven years by NIAID contracts to five institutions. Funding for the first year of the contracts will total approximately $24 million. CEIRR will replace the Centers of Excellence for Influenza Research and Surveillance (CEIRS) program, which was supported by contracts that concluded on March 31, 2021.The CEIRR sites will conduct studies in the United States and internationally that follow cohorts of people to evaluate influenza-related research areas, such as understanding immune responses to vaccination and infection and identifying which immunological factors can determine influenza disease severity. They also will undertake projects on influenza surveillance, including transmission of influenza viruses from animals to humans (zoonotic transmission) to better understand how influenza viruses evolve, adapt and transmit. The sites will prepare studies that could be rapidly launched as part of emergency research responses to outbreaks of influenza and other emerging viral pathogens.Although CEIRR is primarily focused on influenza, the network also will study SARS-CoV-2, the virus that causes ...
NIH     Apr 15, 2021

University of Oxford includes Novavax’s Covid-19 vaccine in study


The University of Oxford has expanded the Comparing Covid-19 Vaccine Schedule Combinations – Stage 2 (Com-COV2) study to include the Novavax and Moderna vaccines for the disease treatment. Earlier, the researchers had selected the Oxford-AstraZeneca vaccine and the Pfizer vaccine to investigate their alternating doses. Supported by the UK Vaccines Taskforce, the investigator-initiated phase II clinical trial will analyse Novavax’s recombinant protein vaccine candidate NVX-CoV2373 as one of four Covid-19 vaccines. It will assess the potential for combined regimens that mix vaccines produced by various companies to achieve immune protection against Covid-19. A protein-based vaccine candidate, NVX-CoV2373 is engineered from the genetic sequence of SARS-CoV-2 and has Matrix-M adjuvant. Novavax executive vice-president, chief medical officer Filip Dubovsky said: “Novavax’s addition to this important study reflects the urgency of finding innovative ways to protect as many people as possible in a dynamic pandemic landscape.” The trial will enrol 1,050 adult subjects aged 50 years or above who received their first dose of a Covid-19 vaccine in the past eight to 12 weeks. They will have received either the Oxford-AstraZeneca or Pfizer vaccine and will be randomly allocated to receive either the same vaccine for their second dose or a dose of the Covid-19 vaccines of Novavax or Moderna. Novavax noted that 350 of the subjects will receive NVX-CoV2373. Thematic Reports Are you worried about the pace of innovation in your industry? GlobalData's TMT Themes 2021 Report tells you everything you need to know about disruptive tech themes and which companies are best placed to help you digitally transform your business. Find out more The immune system responses from people receiving a heterologous regimen compared with those receiving a homologous regimen will be evaluated in the study. University of Oxford...     Apr 15, 2021

Applied DNA, Evvivax announce positive results from phase I trial of LinearDNA Covid-19 vaccine candidate in felines


Applied DNA Sciences and its programme development partner, Evvivax announced positive preliminary phase I clinical trial results for a LinearDNA Covid-19 vaccine candidate (the “vaccine candidate”) in adult domestic felines. Results following administration of a single prime dose of the vaccine candidate on day 1 in late February indicate that the LinearDNA vaccine candidate is well-tolerated by the cohort. A SARS-CoV-2 neutralization assay was conducted by the Cornell University Animal Health Diagnostic Center at the College of Veterinary Medicine 20 days after prime dose delivery to establish the immune response of all cohort members.The results of the neutralization assay yielded high titers of SARS-CoV-2 neutralizing antibodies (NAb) from all cohort members. Follow-on NAb assay results after administration of the vaccine candidate booster are expected to be available in late April 2021. Based on the initial promising NAb titers after a single prime dose of the LinearDNA vaccine candidate, the companies intend to extend the evaluation of neutralizing antibodies in select cohort members through September 2021 to determine the durability of the immune response.Dr. Diego Diel, D.V.M., M.S., Ph.D., Associate Professor of Virology at the Cornell University College of Veterinary Medicine’s Department of Population Medicine and Diagnostics, who performed the NAb assay, stated, “The levels of neutralizing antibodies elicited in the vaccinated cats after only a single prime dose are compelling. Based on these preliminary data, it seems like this vaccine candidate has the potential to be effective in cats and perhaps other COVID-19-susceptible animals such as ferrets and minks.”Dr. Joseph Impellizeri, DVM, DACVIM (O), MRCVS, veterinary oncologist at Guardian Veterinary Specialists (GVS) in Brewster, and Trial Supervising Investigator for the study, said, “Administration of the vaccine candidate via electroporation was well-tolerated with no adverse events in the n...     Apr 14, 2021