Velocity Clinical Research in Medford received its first group of participants Tuesday for a phase three clinical trial for a COVID-19 vaccine called Novavax, joining about
70 sites in the U.S. working on the trial, according to Medical Director Dr. Gregg Lucksinger.
The study is for adults 18 and older. People with unstable conditions that require urgent attention may not qualify.
On Dec. 28, Novavax announced initiation of PREVENT-19, the phase three component of previous phase studies showing a “robust immune response,” according to a company press release.
The initiative is supported by Operation Warp Speed, with the goal to produce and deliver 300 million doses of vaccines in the U.S.
Lucksinger leads the Velocity study, bringing more than 30 years of experience in family practice and research on HIV, Dengue fever, influenza, bacterial meningitis and other clinical studies since 2001.
Participants will include as much ethnic diversity as possible, and people at elevated risk of exposure through their occupation, Lucksinger said.
“In some studies, they’re very picky and they only want normal, healthy people. This is not that kind of study,” Lucksinger said.
“We want the full range — we want young people, middle age, older people and we want people with medical problems because those are the people that are at most risk if they get COVID,” he said.
He aims to enroll 400 people in the trial at the Medford site within four weeks. Velocity is continuing studies on the Moderna and Janssen vaccines, while the Novavax phase three study gets underway.
The goal with any vaccine is to introduce a person’s immune system to a component of the infecting organism and prevent it from taking hold, Lucksinger explained. The Pfizer and Moderna vaccines, made available through FDA emergency use authorization, use new technology never before approved for use in humans.
Novavax is built using a “more traditional” approach to vaccine development, Lucksinger said.
Novavax is constructed from the SARS-CoV-2 spike glycoprotein, reproduced on a large scale and mixed with an adjuvant that “magnifies” and shapes the immune system’s response to the protein. When the body produces antibodies that bind to the spike protein, the virus cannot stick to cells, replicate and cause illness, he said.
The trial vaccine uses a proprietary, highly active new adjuvant that has the potential to develop high levels of immunity, Lucksinger said.
“It’s important to have different vaccines using different technologies they often require different raw materials to produce them,” Lucksinger said. “One issue that you have is if all the vaccine manufacturers are using the exact same or very similar technologies, then they’re competing for raw materials, and sometimes that can limit the ability to make vaccines.”
Lucksinger said based on experience with different flu vaccines, some work better than others in particular age groups and administration settings. He hopes a variety of vaccines will prove safe and effective for mass application where they have best use.
Novavax is produced by a manufacturer in North Carolina.
In the Novavax study, staff working directly with trial participants do not know whether the subject is receiving the trial vaccine or a placebo, according to site director Danuel Hamlin. Study coordinators prepare the syringe and hand it over for administration, without sharing any information that could compromise the blind study. Two of three patients in the study will receive Novavax.
Similar to a flu vaccine, side effects of Novavax may include fever, fatigue and redness, swelling and soreness at the injection site.
As some have raised concerns about the speed with which these vaccines are coming on the market, Lucksinger said he is confident in the accuracy of the process.
“Our job is not to get a vaccine or a drug approved. Our job is to collect high-quality data in a timely manner so that it can be analyzed by the experts who then use that to make a decision whether or not something gets approved,” Lucksinger said, adding that funding or pay is not affected by the outcome of their data collection. “We don’t work for the pharma companies — we’re subcontracted out for that reason.”
Research for COVID-19 vaccines builds on research accumulated during the original SARS outbreak of 2002-2004 and a more recent outbreak of Middle East Respiratory Syndrome, he said — two closely-related viruses with spike proteins that bind to cells in a similar manner. Making a simple switch with the correct COVID-19 spike protein saved an estimated 12-18 months of study time.
“It is true that these vaccines have been developed at a historically rapid rate, but there are some factors that are driving that, that are not shortcuts,” Lucksinger said.
Companies developing the vaccines accepted substantial financial risk by mass producing their product before FDA approval, recognizing that hundreds of millions of dollars might be for nought if approval doesn’t come through, he said. Simultaneously speeding up the timeline means each trial has a vast data set to work with.
The FDA typically requires that studies track participants for two months before reviewing trial data. Thus far, Lucksinger said, he is confident in early results.
“Is it possible that there’s some side effect that will only show up four or five years down the road? Possibly,” Lucksinger said. “But there’s no way we can know that until we get four or five years down the road, and it doesn’t seem like a good idea to wait that long before bringing a vaccine to market.”
A larger study group returns reliable, statistically significant results in a shorter period of time, he said.
This high-priority project has brought on more trial sites and resources to quantify effectiveness through interim analysis for the FDA to review as quickly as possible, rather than in increments over several months, Hamlin said.
“I have been here for 20 years, and we’ve never had an FDA inspection mid-study,” he said. “They were focused to make sure that we were collecting the data in the correct way and that the study was being run properly it’s not that steps are being missed, it’s that steps are being fast-tracked and prioritized.”
While much of the population awaits access to vaccines, likely not until mid-2021, this study is one way for two-thirds of trial patients to get vaccinated, Hamlin said. For the Moderna study, those who received the placebo during the trial will still receive the active vaccine. Other companies are expected to do the same, he said.
Trial participant Christine McCollom, director of programs for the Ashland School District, said she elected to participate as a way to get vaccinated while awaiting widespread public access, in line with her role monitoring health and safety requirements for teachers and staff.
After months of distance learning, constantly changing infection metrics and Gov. Kate Brown’s announcement Dec. 23 that schools may return to in-person learning by February, many educators are concerned about going back to school without a vaccine, she said.
Participants are free to withdraw at any time and can be “unblinded” to find out what they received in the trial before obtaining another vaccine that may become available, Hamlin said. Compensation is $100 to $125 per visit for the time and effort of participation, in addition to illness check visits if necessary.
Contact Ashland Tidings reporter Allayana Darrow at firstname.lastname@example.org and follow her on Twitter @AllayanaD.