COVID-19 vaccine trials come to Portsmouth’s ActivMed and volunteers are wanted
PORTSMOUTH — ActivMed, a Portsmouth clinical research center, is participating in the trials for a COVID-19 vaccine being developed by AstraZeneca.
Located at 110 Corporate Drive at Pease International Tradeport, ActivMed seeks to get at least 1,000 participants into the trial for AstraZeneca’s AZD1222 vaccine, one of three vaccine candidates the federal government is funding for Phase 3 trials under Operation Warp Speed.
The other two are BioNTech's BNT162 and Moderna’s mRNA-1273. Another Pease company, Lonza Biologics, is currently manufacturing Moderna’s vaccine in what has been described as “small batches” in the run-up to possible full production.
ActivMed is one of 62 sites across the U.S. for AstraZeneca to test the safety of its vaccine on a total of 30,000 participants. It is the only site in New Hampshire currently being used for a vaccine study.
“If we don't come up with a vaccine, it's not going to be a better quality of life for any of us,” said Terry Stubbs, founder and president of ActivMed Practices & Research. “We're all going to run in fear, we're going to be afraid, and there has to be a vaccine because that's the only solution.”
AstraZeneca announced in April its collaboration with Oxford University for the global development and distribution of the university’s vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. The virus, to date, has sickened almost 34 million people worldwide and killed more than 1 million.
Operation Warp Speed aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021. The Phase 3 trials of the vaccines it has green-lighted for fast tracking puts them in the latter stages of development and approval.
According to the National Institute of Health, Phase 3 trials use human volunteers to evaluate the overall risks and benefits of the drug.
Stubbs, who started the business 23 years ago, said AstraZeneca selected ActivMed as one of its trial sites because of its proximity to colleges and universities in the region, considered what Tubbs called “hot zones,” given the potential spread of the virus on campus. She said her location can also draw volunteers from Maine and northern Massachusetts, in addition to the Granite State.
She did contact Moderna to let it know of her willingness to also test its vaccine.
Moderna’s vaccine is being studied in 100 locations across the country, with Massachusetts being the only New England state.
According to Stubbs, details of the trials at her facility will be finalized at a meeting scheduled for Thursday and the actual tests of the vaccine will start next week.
If you want to volunteer
Information about the trials and how to sign up can be found at activmedresearch.com.
Stubbs said any adult 18 years and older can volunteer. They must be in good health or in “good managed health,” according to Stubbs. Someone with high blood pressure, for example, is eligible if they are taking medication to control the condition.
Two of every three volunteers will get the vaccine shot while the third will receive a placebo. It is a so double-blind study in that volunteers don’t know if they are receiving the experimental treatment or placebo.
Stubbs plans to reach out to recruit volunteers through the use of social media, postings in medical offices, and newspaper advertisements.
Stubbs is aware of the social divide that surrounds the COVID-19 pandemic, how some people take it seriously and heed advice as it relates to face coverings and social distancing, while others eschew the advice with the belief it is a hoax or is being overstated.
She is also aware some people might be reluctant to participate in a trial of a vaccine that some people believe is being rushed into public distribution too quickly.
The antidote on both counts, she said, is education.
The consent form for the vaccine contains a lot of information, as will information packets. She encourages people to talk with her staff about the vaccine trial either in person or by way of a call.
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The path forward
“Education will be the best way to let people know what it is, how it goes,” Stubbs said.
She does not feel the process of getting a vaccine out to the public is being rushed. While the timeline for getting a vaccine approved can take up to seven years, Stubbs notes the polio vaccine, approved in 1955, took 18 months.
“That was the fastest largest clinical trial ever done and mankind history,” Stubbs said. “A really good example is the polio trial.”
What allows this process to proceed as quickly as it has is the ability to communicate and share results and data almost instantly via the internet and worldwide communication systems.
“The good thing is other pharmaceutical companies are sharing the information really fast,” Stubbs said. “Once the results are coming through they're sharing the results, and that's never been done before.”
As the trials of the various vaccines proceed, Stubbs said she believes different vaccines might be needed for different people, depending on their physical makeup, in the same way that there are different antibiotics.
“Some vaccines may work for some people, and they may not work for others, and that's why they’re actually looking at seven different kinds of vaccines, just like the same in medicine, depending on your system and your DNA,” she said.
ActivMed, which also has offices in Methuen, Lawrence, and Beverly, Massachusetts, has been involved in many clinical trials associated with vaccines and medications, including treatments for the swine flu pandemic in 2009.
