This story is from last week’s blog. I’m rerunning it because their still looking for trial subjects. Since it ran this virus has been in the news because AstraZeneca said it was doing really well in early trials overseas, then faced concern about how they were reporting the results. The weird thing is that test subjects did better with a half-dose followed by a whole dose, as compared to a whole dose followed by a whole dose. NY Times story here.
Hundreds of New Hampshire residents are being sought to participate in a trial of a COVID-19 vaccine as reports spread of great success with other vaccines.
ActivMed’s Portsmouth office is seeking 1,500 people in New Hampshire, Maine and Massachusetts to participate in the final step before the release of a COVID-19 vaccine being developed by British pharmaceutical giant AstraZeneca. It is one of 100 sites in the U.S. running what is known as Phase 3 clinical trials.
Participants will get two shots about 30 days apart and must keep track of their health over the following two years. One-third of the volunteers get a placebo, a shot that has no active medical effect, and two-thirds get the vaccine. There’s a $100 travel payment for each of the 7 visits required during the clinical trial.
ActivMed CEO Terry Stubbs said the company started enrolling volunteers Nov. 6 after New Hampshire was declared a “red zone” due to widespread COVID-19 infection. It is much easier to test a vaccine against a disease when it is widespread because you can be more sure that participants have encountered the disease in their daily life.
About 250 people have enrolled so far and the company is actively seeking more to meet the rush for dealing with COVID-19. Volunteers must be between 18 and 85 and be healthy, although they can have a condition such as hypertension if it is controlled by medication. They cannot have already had COVID-19, however.
The COVID-19 vaccine trials have been speeded up from normal protocols, part of what is known as the “Warp Speed” approach to tackling the disease. As a comparison, Stubbs noted that when ActivMed ran critical trials for a vaccine against an upper respiratory virus they had to find 500 patients.
“This one, with 1,500, is much more. We have to make sure that we’re staffed, have everything ready,” she said. “It’s more intense.”
The vaccine made by AstraZeneca is a different type than the vaccines by Moderna and Pfizer that in the past week announced Phase 3 trial results. Both vaccines reported more than 94% success in preventing infection.
Those two vaccines are based on messenger RNA, genetic material that creates certain proteins which are also made by the CoV2-SARS coronavirus. Creating these proteins “teaches” the patient’s immune system to recognize them so when the coronavirus shows up, the immune system will react quickly.
AstraZeneca’s vaccine, by contrast, uses a weakened version of a common cold virus to “teach” the immune system. Using weakened or killed viruses is the most common way to develop a vaccine but it takes longer than development using messenger RNA, which is why results have come earlier for the Moderna and Pfizer candidates.
ActivMed is a private company that runs clinical trials under protocols approved by the National Institutes of Health. Stubbs founded it a quarter-century ago near Boston and expanded into Portsmouth about 8 years ago, she said.
The company, which has 45 employees in four locations, often does tests of vaccines, said Stubbs. She noted that its work with the influenza vaccine found that seniors received less benefit “because of how their body metabolizes it,” leading to the new recommendation that people over age 65 get a double dose. The company also tests clinical medical devices. Right now, for example, it’s doing trials of American-made machines to see if they’re accurate enough for people to do home tests for COVID-19.
Stubbs said ActivMed is expanding into doing nutrition trials and trials of Alzheimers treatments.
“We’ve been growing a lot. We’re probably looking over the next year to hire 7 to 10 more employees – nurses, medical assistants, technicians,” she said.
Clinical trials of the AstraZeneca vaccine were halted in September when two patients developed neurological problems that the company said proved to be unrelated to the vaccine. Clinical trials are ongoing in Britain, Brazil, and South Africa as well as the U.S., and aimed for Japan and Russia. The company said Phase III clinical trial will enroll up to 50,000 people globally.
To find out about participating, call ActivMed at 603-319-8863 or check the website: activmedresearch.com.