It’s no secret that, over the last 1.5-2 years, COVID-19 has played a huge role in all of our lives. The novel SARS-CoV-2 coronavirus is present in over 200 countries and territories around the world. Additionally, it is responsible for an estimated 231 million cases globally, as well as 4.74 million deaths. Over this past year, companies have emerged with COVID-19 vaccinations: Johnson & Johnson and Pfizer come to mind. According to a news release from biopharmaceutical companies CyanVac LLC (“CyanVac”) and Blue Lake Biotechnology, Inc. (“Blue Lake”), the companies are also evaluating their own vaccine –  CVXGA1, an intranasal COVID-19 vaccine – in a Phase 1 clinical trial. As of September 27, 2021, the first participant was dosed within this trial.

CVXGA1

So what exactly is CVXGA1, and how would it be used within the modern treatment landscape? First off, many of the other vaccines are intramuscular, meaning that they are administered via injection into the muscle. This can cause a number of side effects. For example, when I received my second Pfizer dose, I experienced extreme lethargy and fatigue, muscle pain and weakness, and slight appetite loss for the next two days. Since CVXGA1 would be administered intranasally, it offers a less invasive option which could spur some hesitant people to receive the vaccine. The vaccine developers also believe that this vaccine could work as either a booster or a primary vaccine.

Altogether, the vaccine uses a proprietary PIV5 vector, or a respiratory vector that is safe for humans. Once administered – as a singular dose in each nostril – CVXGA1 encodes for the COVID-19 spike protein. Thus, the vaccine helps confer an immune response against these proteins. The vaccine has already been evaluated in micro within preclinical studies. During this time, researchers highlighted how CVXGA1 improved immune responses, prompted mucosal antibody response, and helped halt the transmission, infection, and spread of COVID-19.

CVXGA1-001 Clinical Trial

Currently, researchers are exploring this vaccine option within the Phase 1 CVXGA1-001 clinical trial. On the clinical trial page, researchers list a detailed description of what will occur:

CVXGA1 intranasal COVID-19 vaccine will be administered by dose escalation (low dose to high dose) and age escalation in 80 healthy adults aged 18 to 75 years…with approximately 12 months’ follow-up. Safety data from sentinel subjects assessed by a safety monitoring committee (SMC) for 1) vaccine administration to the remaining subjects within the group, 2) progression from low dose (1 x 10^6 PFU) to high dose (1 x 10^7 PFU) and 3) progression from the young adult cohort (18 to 55 years) to the older adult cohort (56 to 75 years).

While researchers will collect safety data and other information, it is unclear when those findings will be shared publicly.