Lyme disease vaccine trial coming to Block Island

Vaccines available starting August 5
Fri, 07/29/2022 - 4:00pm
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You may have seen the trailer at the Block Island Power Company and wondered just what is it doing here? Well, on Wednesday, two gentlemen who were on Block Island for the first time, stopped by The Block Island Times office to tell us about it.
Gerhart Keller, a retired nurse who has gotten back in on the action, is from Pennsylvania, and Jerodney Spicer, a patient educator, is from South Carolina. Keller and Spicer both work for Care Access and the trailer is here for what is called a “pop-up clinical trial” that Care Access is conducting on behalf of Pfizer, the creator of a potential new vaccine for Lyme disease. You may see them around town in the coming weeks as they educate the public about the trial.
Most people who live on Block Island, and countless visitors have experienced Lyme disease, which is transmitted to people via the tiny deer tick. When left untreated or undiagnosed, Lyme can cause serious long-term health problems from general fatigue to joint and heart problems.
The launch of the trial started on July 25, and they will continue to enroll people through December. Fifty percent of all participants will receive a saline placebo, and 50 percent will get the vaccine. The trial is approved for participants aged five through 65 years old. It is free to participate, but besides the shots themselves, you will need to attend at least seven in-person study visits over the course of 30 months. You may be reimbursed for “expenses and time related to completing certain study tasks,” according to the website ValorLymeStudy.com. You may leave the study at any time if you change your mind.
This phase three trial is the last step before the vaccine goes to the Food and Drug Administration for final approval. Phases one and two, completed in July 2021, evaluated the vaccine for safety, and there were 625 participants in phase two alone.
Phase three will be evaluating the vaccine for its efficacy – how well it works. This means that participants must self-monitor and report every symptom they experience whether it seems related to Lyme or not - even a sniffly nose.
After signing up through the website, participants will be contacted within 24 hours to set up an appointment. The first step at the appointment will be to review and complete the required consent forms. Following that, a comprehensive health evaluation will take place and if you “pass,” you will receive your first dose.
The first appointments on Block Island will take place Friday, August 5.
Like many vaccines, more than one shot is needed. In all, there will be four injections – three over a five- to nine-month period, and the fourth after 12 months.
To properly evaluate the vaccine, Pfizer and Care Access need thousands of people to sign up. The target regions are in Minnesota and Wisconsin, and up and down the east coast from Virginia to Maine, the areas where Lyme disease is most prevalent. One caveat though for people on Block Island, you must receive your shots and have your follow-up visits in the same state. So, if you move between states you may have to determine the best place to sign up, or rearrange travel plans to accommodate having those first three doses over
that five- to nine-month period and to do your follow-up visits.
Help is available at any time by phone, and you will be able to speak to a “live person” at any time.
To learn more, go to the website www. ValorLymeStudy.com.