As a handful of the most promising COVID-19 vaccine candidates move into the next phase of human trials, tens of thousands of people across the country are being recruited to show the vaccines work, including residents of Anne Arundel County.
Anne Arundel Medical Center and Doctors Community Hospital in Prince George’s County will begin a COVID-19 vaccine trial in the next month with a vaccine candidate developed in Oxford by Oxford University’s Jenner Institute and manufactured by Swedish-British pharmaceutical company AstraZeneca. The vaccine has shown promising results in early clinical trials.
Several vaccine candidates have moved into large-scale phase 3 trials, recruiting thousands of volunteers across the globe to receive a vaccine, or a placebo, that could boost immunity against SARS-CoV-2, the novel coronavirus that causes the disease COVID-19. AAMC, in partnership with John Hopkins Medicine and the National Institute of Health, hopes to enroll 50 to 100 people in the study, among 30,000 people participating in the United States.
The hospital encourages people at higher risk of contracting COVID-19 to participate in the study, including those with pre-existing health conditions and Black and Latinx communities disproportionately impacted by the virus.
“No matter how good our therapies are, this disease is still going to have a major impact on our society, on our economic development, and on our way of life, like going to school,” said Dr. Barry Meisenberg, chair of AAMC’s Department of Medicine. “From the very beginning, people have pointed out that ultimately we’re going to need a vaccine that would be widely distributed in order to return to a more normal state.”
Phase 3 studies are the final step before the U.S. Food and Drug Administation decides whether to approve the vaccine. There are more than a hundred vaccines in development and one could be approved by late this year or early next year. Until the study is over there is no guarantee the vaccine candidates provide immunity, or lasting immunity, to COVID-19, although the chance that none of the vaccines are successful is small, said Wilbur Chen, Professor at University of Maryland School of Medicine and Center for Vaccine Development and Global Health.
“We continue to see success,” Chen said. “We would like to see multiple vaccines licensed and approved because any one company that is successful is not realistically going to be able to make vaccine enough for all the U.S. population save for all the world.”
The Oxford vaccine is among six candidates entering or operating in the third phase of clinical development in which a vaccine, after showing success among a smaller pool of volunteers, is given to thousands of people to test for safety and robust immune response. Phase 3 trials also need to prove a vaccine’s efficacy by showing the product is at least 50% more effective than the placebo in decreasing the rate or severity of COVID-19 infection, per FDA guidelines released in June.
The University of Maryland announced Monday it will begin a trial with a vaccine developed by Massachusetts biotech company Moderna and the National Institute of Health. Moderna’s vaccine candidate was the first to be announced under Operation Warp Speed, the federal program that fast tracks a pharmaceutical company’s ability to produce and distribute millions of doses of a COVID-19 vaccine before the trial ends.
“However, the rolling out of the vaccine, and the trial, and the testing of it, that is not being hasty,” Meisenberg said. “That’s being done very deliberately and carefully.”
Local participants of the randomized trial will join thousands of people across the country receiving two shots, spaced a month apart, of the vaccine or a placebo. Subjects then return to their normal lives and are routinely monitored with blood tests and other measures to check if they have contracted COVID-19 or had an immune response, such as developing antibodies. Antibodies are a protein the body makes after infection to fight the virus. The process will take months.
AAMC’s trial is set to begin late August or early September. Inquiries can be made by emailing Research@AAHS.org.
Once enough people are confirmed sick with COVID-19, the study will look at the combined 30,000 test subjects and compare how many placebos developed the disease against how many vaccinated people develop the disease.
The Oxford vaccine uses an adenovirus vector, a well-known virus like the common cold, that’s weakened to be less severe in humans. Scientists then engineered a coronavirus spike protein — the part of the virus the immune system identifies first — so a person vaccinated for COVID-19 develops an immune response against it. Once immunized, the body’s defenses will kick start when exposed to the actual coronavirus by recognizing it early and stopping the disease before it develops.
The adenovirus vector used in the Oxford vaccine is a chimpanzee adenovirus so it can’t replicate or cause an infection in humans.
“That’s how it’s been engineered or designed to be safe and still develop a really good immune response,” Chen said.
AAMC wants people at high risk of getting COVID-19 to participate in the study, including people over 65 years old with multiple medical problems, those with hypertension or diabetes, health care workers in nursing homes and Black and Latinx communities. The FDA plans to launch a mobile van to reach populations that have less access to transportation and have trouble getting to a health facility.
“We want to study in these most important parts of the population,” Chen said. “We’re really interested in protecting the most vulnerable parts of the population at highest risk that have the highest severity of illness.”
The Oxford vaccine is already in its third phase in low-to-middle income countries such as Brazil and South Africa, according to the university.
Baltimore Sun reporter Meredith Cohn contributed to this report.