Forward-Thinking Trial Site Organization Enrolling up to 500 Volunteers for COVID-19 Vaccine Study

Forward-Thinking Trial Site Organization Enrolling up to 500 Volunteers for COVID-19 Vaccine Study

Portsmouth, New Hampshire-based ActivMed Research is actively seeking 500 volunteers to participate in COVID-19 vaccine research to help determine the overall safety and efficacy of the AstraZeneca (Oxford) vaccine, now called AZD1222. Found recently to hit an effective rate average of 70 percent while the use of a half dose, followed by a full dose led to a 90 percent effective rate based on a total of 131 COVID-19 cases in a study involving 11,363 participants. ActivMed, an independent research site profiled by TrialSite previously, has been on the forefront of accreditation development as this trial site organization’s founder and CEO, Terry Stubbs, has helped contribute to the development of the Site Accreditation Standards Institute (SASI) trial site organization accreditation initiative

A Volunteer Hero

A participating volunteer in this study was highlighted recently in NPR New Hampshire, authored by Jordyn Haime. Apparently, Lori Tyler Gula from Lee, New Hampshire, stepped up to contribute against COVID-19: all must remember fighting back and finally overcoming and beating COVID-19 requires as many people in society as possible to get involved somehow. Of course, the motivations to engage and give back may vary; in the case of Lori Tyler Gula, it came down to concern for her parents, who face a higher risk.

In this case, Lori Tyler Gula received her first dose of either the vaccine or placebo (remember the study is blinded) last week. In a few weeks, she will receive the second dose. She was quoted in the NP New Hampshire article, “I’ve had a lot of friends who have gotten COVID and I’ve had some friends who have lost family because of it, and so anything I can do, that’s what I wanted to do.”

The Experience Thus Far

Up to now, the volunteer reports some mild effects in the 24 hours post-vaccine administration, similar to flu vaccine side effects reports Ms. Haime. ActivMed’s CEO shared that there are few long-term side effects reported thus far.

The Vaccine Candidate

AZD1222 was originally developed by Oxford University’s Jenner Institute and Oxford Vaccine Group. These University of Oxford (UK)-based groups commenced research on the specific COVID-19 vaccine candidate on January 20, 2020. Originally known as ChAdOx1 nCOV-19, the virus is derived from a weakened version of a common cold virus known as an adenovirus that actually causes the condition in chimpanzees. Genetically modified, the vaccine candidate can now work in humans.

Some Challenges

TrialSite has reported some challenges with AstraZeneca’s study. For example, the clinical trial was delayed in the United States for several weeks while the U.S. Food and Drug Administration (FDA) reviewed a safety incident that occurred in the UK. Ultimately, the world’s top regulator deemed the trial safe to proceed. Most recently, AstraZeneca reported on preliminary results based on 131 COVID-19 cases in an overall study involving 11,363 volunteers. These interim takeaways were somewhat confusing as apparently the full regimen (two doses) led to a 62 percent effectivity at preventing the pathogen. But the UK-based company also reported that a half dose, followed by a full dose administered led to a 90 percent effective rate. According to a recent report by Helen Branswell and Adam Feuerstein writing for STAT, AstraZeneca may consider adding the half-dose regimen to the study: this would require regulatory acceptance of course.

TrialSite summarized the overall challenges of late for AstraZeneca. 

Study Completion

Apparently, the AstraZeneca trial needs about a total of 1,000 more healthy volunteers in the United States. Participants can be between the ages of 18 and 85. Ms. Stubbs reports that those that have had high blood pressure or diabetes with controlled levels can also potentially participate in the research. It should be noted that with COVID-19, those with “comorbidities,” that is, other conditions such as diabetes, high blood pressure, pulmonary problems, etc., face higher risks with COVID-19.

CEO Stubbs reported to the local media that if clinical trials in the United States are successful AstraZeneca could have the vaccine in distribution by the Spring, just a few months away.

Moving Forward

Overall, thousands of volunteers have stepped up all over the world to participate in the AZD1222 (Oxford) vaccine clinical trials. From the UK and South Africa to Brazil, India and of course, America, tens of thousands of people have been inoculated with either this vaccine candidate or placebo. The FDA has been very diligent with this and all vaccine candidates and hence the green light after a delay of the trial in the United States. That is why the study is deemed safe for volunteers such as Lori Tyler Gula to participate in this important research.

The world needs at least several high-quality, safe and effective vaccines to fight off what has become not only the world pandemic in a century but one that threatens modern life. That our modern life has been impacted is an understatement. The economic implications of what has occurred will take an immeasurable toll as has the already tragic loss of life. The only way to counter this crisis is a combination of vaccine and therapy research, identification of proactive early COVID-19 vaccine onset treatment and good local, regional and national health policy.

TrialSite commends COVID-19 vaccine trial volunteers. These individuals, along with the heroic ongoing efforts of healthcare professionals (doctors, nurses physician assistants, nurses aids, various technicians and support staff, etc. along with research teams) are on the front lines of a war of a lifetime. 

Call to Action: If you are based in the Portsmouth, NH, area consider participation in the effort to fight COVID-19. In addition to the basic responsibility all have to maintain appropriate distance, wear masks around others, etc. involvement in research is traditionally a way that humanity advances the biomedical line forward. Reach out to ActivMed