Confluence study focused on one of four types
People don’t always eagerly line up to get poked with a needle, but the 180 spots to participate in a COVID vaccine trial through Confluence Health in Wenatchee were all snapped up right away.
The trial is one of only two in Washington. The study has already enrolled all the participants that are needed, said Steven Kaster, medical director of the clinical research department at Confluence Health and principal investigator for the study of a Pfizer vaccine.
After an article about the study in the Wenatchee World at the end of August, “the phone ran off the hook,” Kaster said. They required very little publicity to recruit participants, he said.
The Confluence study is evaluating the effectiveness of a vaccine developed by Pfizer — one of four vaccines currently being tested around the world.
It’s helpful that four vaccines are being studied, both to provide more diversity and greater availability when one or more vaccines is approved, Kaster said.
The vaccines being tested don’t use a live virus, so it’s not possible for participants to become infected with COVID, Kaster said.
The Pfizer study is in Phase 3, meaning that the vaccine has had preliminary safety testing. This study won’t be complete for two years, and researchers can’t predict when a vaccine will be approved for general use, Kaster said.
The study is an observer-blind, randomized study. Half the people receive the vaccine and half get a placebo. The researchers and the participants don’t know who gets what. The randomization is created by a computer program.
“We need to remain blinded to the data, including treatment arms and antibody levels. If researchers knew, it would create a bias in judgment when reporting adverse events, especially since there’s nothing to compare it with, other than a placebo,” Kaster said.
Diverse participants
The vaccine trial aims for diverse subjects who reflect the population in the region. Confluence has prioritized those with some degree of risk, such as front-line health care workers, first responders and respiratory therapists, Kaster said.
Enrollment criteria are very strict. This study enrolls people age 16 and above. Those with certain health conditions are excluded.
“It doesn’t take much time to be a trial participant. The medical staff are very professional, and I’ve had no real side effects (just soreness where the shots were given),” said a participant from the Methow Valley.
“I want to help move science forward. We need a vaccine, and so it means healthy volunteers need to be in the trials. It’s the only way to get things moving along faster to help more people survive this pandemic,” she said.
The vaccine trial is looking to answer three big questions: Do the people who got the vaccine develop a good antibody and white-blood-cell response? Does that translate into protection against COVID? And, if so, how long does the protection last?
Study participants get two doses of the vaccine, three weeks apart, and then are checked at four more intervals — at one month, six months, one year, and two years. They are closely followed for any type of reaction and tested for antibodies. They are also tracked to see if anyone gets COVID.
Political pressures?
While vaccine trials are following rigorous scientific standards, they’re taking place at a fraught moment, with the presidential election less than one month away.
In June, the U.S. Food and Drug Administration (FDA) released guidance to ensure vaccine safety and efficacy. The agency updated the guidelines late last month to include a requirement that all participants in vaccine trials be followed for at least two months after the second dose before any vaccine could be approved. The updated guidelines were presented to the White House two weeks ago.
Officials in the Trump administration have been reviewing the stricter guidelines and announced Monday (Oct. 5) that they don’t intend to approve the stricter standard.
Trump has promised repeatedly that a vaccine will be available in October, presumably to help his re-election bid. After physicians made a presentation to Congress last month about the need for rigorous guidelines, Trump called the stricter guidelines “a political move.”
The pharmaceutical companies developing the vaccines issued a statement in September intended to reassure the public that they would follow strict scientific protocols to ensure that any vaccine is safe and effective. Some have said they will follow FDA guidelines regardless of the position of the White House.
A committee of independent experts is scheduled to meet Oct. 22 to review the latest FDA guidelines.
Vaccine types
The four vaccines being tested worldwide are based on two different principles. The Pfizer vaccine uses a genetically modified version of messenger RNA, which creates a protein that resembles the spike protein of the COVID virus. The body develops antibodies that attack those proteins.
The other type of vaccine uses a weakened version of the virus that causes the common cold that’s been modified with genetic materials from the virus that causes COVID to stimulate an immune response.
Ideally, the vaccine will prevent COVID. If people who’ve been immunized do develop the disease, scientists want to see the vaccine keep infections very mild, Kaster said.
The data from vaccine trials are reviewed in real-time by a committee of academics, virologists and biostatisticians with no connection to the vaccine developers. The committee, which is unblinded, looks for safety signals and red flags and can stop a study at any time if there is a concern.
If the committee sees a significant difference in the COVID infection rate between those who got the vaccine and those who got the placebo, that could potentially speed up the approval process, Kaster said.
The Pfizer study began in April, but U.S. trials didn’t start until late August. The design calls for about 44,000 participants worldwide. The Pfizer study is being conducted at 166 locations in 38 states — some with just a few sites and some with dozens. The other site in Washington is at Virginia Mason in Seattle.
Participants keep a diary of side-effects and of any symptoms consistent with COVID-19. Follow-up appointments with study participants look for any adverse health events, Kaster said. That could even be a sprained ankle or bronchitis — not a reaction obviously connected with COVID. With the large number of participants, researchers can detect patterns about other possible side-effects of the vaccine, he said.
At the end of the study — at least two years from now — researchers will learn who got the vaccine and who got the placebo. After that, the participants will also find out which they received.
The clinical research department at Confluence Health has been doing drug and vaccine studies for three decades. The researchers have no role in product approval. “We just run the trials as safely as possible and collect clean data,” Kaster said.
Participants get a small stipend to cover their time and gas, but any greater compensation would be viewed as coercive. “Most want to contribute to data and science. Some may hope they get the active vaccine,” Kaster said.
Distribution plans
The federal government is developing plans for vaccine distribution, since there won’t be enough for widespread immunization at first. In September they selected four states and a city for the first doses, and Washington was not among them, according to the Washington Department of Health (DOH).
DOH is doing as much as possible to ensure that the process runs smoothly. The federal government will determine which populations will be prioritized to be offered the vaccine. Possibilities priority groups are essential workers, health care workers, and residents and workers at long-term care facilities, DOH said. DOH has received $5 million in federal funding for vaccine-response preparation.
“DOH is committed to science and the need to critically evaluate these new vaccines for their safety and efficacy in an unbiased way before their use,” DOH State Health Officer Kathy Lofy said. “We will be watching the FDA approval process closely to make sure it is thorough and transparent.”
