While the United States could be just days away from getting its first doses of the Pfizer COVID-19 vaccine, clinical vaccine trials on Pfizer, Moderna, AstraZeneca and Janssen vaccines are ongoing, and at least one is underway at the Rocky Mountain Veterans Administration Medical Center in Aurora.
According to a statement from the VA Office of Research and Development, at least 50 separate clinical trials are taking place at VA medical centers around the country. In 2020, three clinical trials — two on a COVID-19 treatment and one on a vaccine — were conducted at the Aurora VA Medical Center. Two are still ongoing.
The trial completed in July looked at the efficacy of the COVID-19 treatment Remdesivir on 1,034 hospitalized adults. A second look at Remdesivir that tested the drug with 969 hospitalized participants is set to end on Dec. 30.
A clinical trial on the Janssen vaccine candidateis the largest of the three and the only one testing a vaccine, and it’s long-term, with a study period of two years and three months.
Known as the Ensemble study, according to Johnson & Johnson, during the study staff collect blood samples, saliva samples and nasal swabs. If a participant becomes sick with COVID-19, study staff will monitor the participant daily and obtain extra nasal swabs and saliva samples. Johnson & Johnson says participants cannot get COVID-19 from the vaccine.
The study will be conducted in two stages for each age group. The first group consists of 2,000 participants ages 18-59 who do not have other health conditions. After they have received the injection of the study vaccine or placebo and have been observed for 3 days following the injection, all the remaining participants in that age group will be enrolled. The same process will be followed for the group ages 60 and older. Participants will be informed whether they are in the first group or in the second group.
While two years may seem like a long time for a study, normally, vaccine clinical research studies can take 10 to 15 years to complete, according to Johnson & Johnson.
However, “during the current global COVID-19 pandemic there is an urgent need to speed up vaccine research. Clinical research study timelines can be compressed by overlapping some research and development steps. Another way to speed up the process of finding a vaccine that works, without compromising safety, is to test as many investigational vaccines as possible. For this reason, collaboration during pandemics between vaccine developers and national/international health organizations can be beneficial.”
The study began on Sept. 7 and is expected to conclude in March 2023, with a goal of 60,000 participants worldwide.
Among the participants in the first age group is Kelli Fritts, the associate state director for AARP of Colorado.
Fritts told Colorado Politics that she learned of the study from a friend, a nurse at the Anschutz Medical Campus. After getting the nasal swab and blood tests, her biggest responsibility is keeping a diary through an app on her phone. Fritts got the shot Nov. 11; there won't be a second one. She doesn’t know whether she got the vaccine or a placebo.
“I never served in the military. I don’t give blood. This is one thing I could do,” Fritts said, when asked why she decided to join the study.
It’s also her way, she said, of contributing to a goal of getting back to a normal life. “I feel good about it,” she said.
Fritts said there are no restrictions tied to the trials and she doesn’t have to quarantine. Colorado Politics will check in with Fritts periodically to see how the trials are going.
Fritts also encourages people to sign up for the study, which is still accepting participants.