WILMINGTON — A local clinical research company, Trial Management Associates (TMA), in conjunction with Wrighstville Family Practice, will be launching a trial for a new Covid-19 vaccine — one that is plant-based, according to TMA president Phil Datillo.
Though Datillo can’t reveal the vaccine’s producer or how its concept derived, per confidentiality agreements, he said the vaccine has passed preclinical testing and a Phase 1 trial. Now, it moves on to being tested on volunteers 18 and older for efficacy and prevention against SARS-CoV-2. Participants will be paid and must agree to five in-office visits upon receiving the vaccine.
TMA’s pharmacist, Evan Lucas, explained that the vaccine “is produced inside of plants and plant cells instead of animal or human cells as many vaccines are. The plants produce virus-like particles, which look very similar to coronavirus but do not make you sick.”
Once the vaccine enters the system, the particles trigger an immune response, and in effect produce antibodies to fight against Covid-19.
Plant-based vaccines, according to BioSpace and National Center for Biotechnology Information (NCBI), are easily and inexpensively produced en masse. Various plants — potato, carrot, maize, turnip, alfalfa, tobacco, soybean — have been used throughout the years by companies like Icon Genetics GmbH, Creative Biolabs, and iBio Inc. to create vaccines and therapeutic solutions for diseases and ailments, including Ebola and influenza.
“The world’s first plant-based vaccine was approved for the Newcastle disease virus (NDV) by the United States Department of Agriculture (USDA) for poultry,” according to NCBI. “It was shown to confer more than 90% protection in chicken, following the challenges faced with NDV.”
Canadian company Medicago has been creating a plant-based Covid-19 vaccine out of an Australian weed, nicotiana benthamiana — the cousin of tobacco. Trials have been wrapping up elsewhere and the company is eyeing approval by the end of May.
Physician Bart Williams of Wrightsville Family Practice will oversee patients in the TMA plant-based trial.
“The health and safety of our community continues to be the basis for our research,” Dr. Williams said in a release. “Finding safe and effective Covid-19 vaccines, and having a community comfort level to actually receive the vaccine will be the main way we navigate out of this global pandemic. Some patients in our community are hesitant to receive the current COVID-19 vaccines approved by the FDA. We worked hard to secure this trial because the plant-based technology offers an alternative, and everyone who participates in the trial will ultimately receive the vaccine.”
Last year, TMA helped conduct research for the FDA-approved Moderna vaccine through phases 2 and 3. It’s also conducted clinical trials on a meningitis booster vaccine and finding a cure for Hepatitis C, and often opens enrollment to qualified participants in various studies on ulcerative colitis, gout and cardiovascular disease, hypertension, rosacea, and diabetes, among others.
Once the current plant-based Covid-19 vaccine trial ends, Datillo speculates the company may be moving into vaccine studies for boosters that protect folks from Covid-19 variants.
For now he said they’re excited to offer a plant-based alternative to the FDA-approved versions — which, according to NCBI, can be stored easier and made quickly as well: “Plant molecular farming could facilitate rapid production of biologics on an industrial scale, and has the potential to fulfill emergency demands, such as in the present situation of the COVID-19 pandemic.”
TMA is accepting up to 330 participants who have yet to receive a Covid-19 vaccine. Interested parties can contact the clinic at (910) 247-4580.
“We can walk them through the full commitment of the trial,” Datillo said.
Have tips or comments? Email firstname.lastname@example.org