[ad_1]
CyanVac and Blue Lake Biotechnology Announce First Participant Assayed in Phase 1 Clinical Trial to Evaluate Its Intranasal COVID-19 Vaccine CVXGA1
- Details
-
Category: Vaccines
-
Posted on Monday, September 27, 2021 6:37 PM
-
Hits: 51
ATHENS, GA and LOS ALTOS, Ca, USA I September 27, 2021 I CyanVac LLC and its subsidiary Blue Lake Biotechnology, Inc., clinical-stage biopharmaceutical companies developing vaccines using a proprietary vector based on transformational parainfluenza virus 5 (PIV5), today announced the recruitment of the first participant in a clinical trial of phase 1 of their CVXGA1 COVID-19 Intranasal Vaccine in Rochester, NY. CVXGA1 is based on an attenuated strain of PIV5 (also known as canine parainfluenza virus) and expresses the S protein of SARS-CoV-2. In preclinical studies, CVXGA1, administered intranasally as a single dose in each nostril, induced mucosal antibody responses and cell-mediated immune responses as well as serum antibody responses, and was effective in protecting several species. virus infection with SARS-CoV-2 and blocking the viral transmission of SARS-CoV-2. Administered through the nose without injections, the companies’ vaccines have the potential to facilitate the delivery of vaccines to large populations, including pediatric and hesitant groups.
“The recruitment of the first participant to our first Phase 1 human clinical trial marks another important milestone in our rapid growth as a vaccine company,” said Dr. Biao He, Founder and President of CyanVac and Blue Lake Biotechnology. “Our goal is to have a single dose intranasal vaccine that can be used as a booster for existing vaccines, as well as a vaccine that can serve as a primary vaccine for countries that are struggling to acquire enough vaccine doses to their populations. “
“CyanVac’s experimental vaccine has the potential to be both a needle-free vaccine and a vaccine that could block disease transmission,” said Dr. Paul Spearman of Cincinnati Children’s Hospital Medical Center. “For some people, it can help overcome vaccine hesitation, and more importantly, it could stop the virus at its point of entry and prevent further spread of COVID-19. ”
About the Phase 1 clinical trial
The trial is an open-label, multicenter trial to evaluate the safety, reactogenicity and immunogenicity of CVXGA1 administered intranasally as a single dose to adults in two sequential age cohorts. In the first cohort, 40 participants aged 18 to 55 years will receive a single dose of vaccine by intranasal spray, starting at a low dose (106 PFU) at high dose (107 PFU). In the second cohort, 40 participants aged 56 to 75 will receive a single dose of the vaccine, going from a low dose to a high dose. Safety data will be collected and analyzed, as will serum and mucosal antibody responses, and cellular immune responses to the SARS-CoV-2 S protein.
Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT04954287.
About CVXGA1
CVXGA1 is a COVID-19 vaccine candidate based on CyanVac’s proprietary PIV5 vector which encodes the SARS-CoV-2 spike (S) protein. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it is commonly given to dogs as part of combination vaccines against distemper and kennel cough. for decades. CyanVac and Blue Lake Biotechnology are developing CVXGA1 as a single dose intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have shown that CVXGA1 is immunogenic and prevents infection and transmission by SARS-CoV-2.
About CyanVac and Blue Lake Biotechnology
CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies that develop products based on a patented PIV5 vaccine platform licensed from the University of Georgia. Our pipeline includes a vaccine in clinical trials, a second vaccine close to phase 1 studies and additional vaccines in preclinical development. Our primary COVID-19 vaccination program has been selected for future NIH / IDCRC support, while our second program targets respiratory syncytial virus (RSV). RSV is a common respiratory virus that regularly and repeatedly infects people of all ages and is at particularly high risk in children under 2 years of age and elderly patients with underlying lung disease. In addition, the companies have early stage proof of concept vaccination programs targeting noroviruses and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Altos, California.
Learn more at https://www.cyanvacllc.com
THE SOURCE: CyanVac
[ad_2]
Source link
