UP THE FIELD: Meaghan McCamish Since Sept. 17 2,500 Rhode Islanders have chosen to put themselves on the front lines of the coronavirus battle by registering to take part in a COVID vaccine clinical trial. Karen Tashima, MD, director of clinical trials at the
Since Sept. 17 2,500 Rhode Islanders have chosen to put themselves on the front lines of the coronavirus battle by registering to take part in a COVID vaccine clinical trial.
Karen Tashima, MD, director of clinical trials at the Immunology Center and the clinical research site leader for the Miriam Hospital, is optimistic about enrolling in a clinical trial this fall. Multiple pharmaceutical companies, including Novavax, Sanofi, and Pfizer, have begun COVID vaccine clinical trials. Pfizer, which has a clinical trial site in the state, has enrolled 30,000 candidates across the country in clinical trials, but lacked enough minority representation.
Because of this, the company is reopening enrollment to minority participants.
Dr. Tashima is promoting the volunteer registry where people can express their interest in participating in a clinical trial when there is one.
Volunteers who are at substantial risk of getting COVID based on occupation, home life, and daily activities, are needed for the study. Front line workers, participants aged 65 and older, and those with preexisting conditions (like diabetes or high blood pressure) are encouraged to register. The registry collects basic personal information, including name, contact details, and some specifics about past medical history and current risk of exposure. Researchers don't have access to this data until the trial is approved by an institutional review board that independently monitors data and safety.
While a COVID vaccine has yet to be developed, two medications are helping those infected: remdesivir and dexamethasone. Both are available to currently hospitalized COVID patients. But before being approved, both medications had to undergo clinical trials and a series of testing.
In addressing the Warwick Rotary Club on Thursday, Tashima outlined the three phases to vaccine development, following a series of preclinical tests.
“Before the article goes into a human, there's a lot of testing at the bench,” she said.
“The vaccine goes through test tube testing in the lab, where researchers and developers at the pharmaceutical company make sure it does the thing we want it to do,” said Tashima. If the vaccine looks promising in test tube studies, it will progress forward with animal studies.
Tashima explained that animal studies are very helpful, because “it gives us a really good idea of how toxic the medication might be, and what organs of the body might be affected. Once the vaccine passes through these preclinical trials, it will be ready for testing on humans.” At this point, phase one begins.
Tashima said phase one involves a small group of very healthy volunteers. They’ll receive the vaccine or medication, and then see what the side effects are.
“Is it what we would expect from an injection in the arm, like a little bit of a sore arm or maybe a little redness? Or is there something more?”
Researchers may also test out different size doses in this phase as well. Phase one is all about testing for safety. If all goes well in the first phase, the vaccine will move to phase two.
Phase two requires higher enrollment of volunteers. In this phase, Tashima explained, researchers are still testing for safety, but are also looking for effectiveness: How well does it do to prevent a disease or treat a disease? Medications like remdesivir and dexamethasone have successfully passed through the first two phases of trials. Tashima also emphasized that the phase process can be sped up by anticipating the next phase.
Assuming that phase one will be good, [researchers] can plan phase two. However, if phase one was not safe, then [the researchers] would not proceed to phase two. Likewise, researchers can anticipate and plan for phase three while waiting for conclusive data from phase two.
Phase three involves enrolling 30,000 to 60,000 people. The Pfizer clinical trial is currently in phase three.
Tashima explained that phase three is a double blind, randomized trial, where up to half of the volunteers receive a placebo, or a saline injection. “In a placebo controlled trial, researchers and volunteers don’t know if they have received the real vaccine or a saline injection. And that's so important because we do not want to be biased about either side effects or effectiveness. So for example, if we saw that the patient had a very sore arm and we knew that they had the vaccine, of course we would say this is definitely related to the vaccine. But since its double blind and placebo controlled, then we can kind of say, well, a sore arm is expected anytime someone gets an injection.”
Tashima said if participants knew who got the vaccine and who got the placebo, the results of the trial may be skewed. “The people who got the vaccine might go running around town, going to the bars. They might not wear masks, they might say I got the vaccine, Ill be fine. Those patients could be disproportionately exposed to the virus.”
As of last week, 2,500 Rhode Islanders have registered and expressed interest in the clinical trial.
“We want more people to sign up,” urges Tashima. “I'm hoping at the end we'll have 3,000 to 4,000 people sign up at the registry, because then were going to select the participants that we think are going to meet the criteria for this study.”
The goal is to enroll 400 people in the clinical study. The study will run over eight to ten weeks. During that period, Tashima said participants would receive one or two shots, and attend a couple of follow up appointments. Researchers will be asking participants to monitor themselves daily for symptoms. Researchers will also be following participants out for up to two years to understand the long-term effects.
Those who would like to participate in a COVID vaccine clinical trial and want to add their information to the registry, should visit https://www.lifespan.org/centers-services/infectious-diseases/volunteers-needed-covid19-vaccine-trials.