Vaccine Study FAQ's

What is a clinical research study/trial?
A clinical research trial evaluates the safety and effectiveness of a new medication, biologic or vaccine by monitoring its effect on large groups of people The National Institutes of Health (NIH) defines a clinical trial as, “a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments or devices)”. Clinical trials are used to evaluate new biomedical or behavioral interventions for safety, efficacy, and effectiveness.

Who can participate?
Each study may have a differing age range for recruitment, depending on the type of population is needed at that time. Currently we are looking for volunteers for a trial that is expected to happen soon. We need healthy individuals between the ages of 18 – 50 as of dosing day.

What it the time commitment?
This varies from study to study. Please contact our recruiter by phone (802-656-0013), email or fill out this form to learn more about time commitments for currently recruiting studies.

Will I receive any compensation?
Typical compensation for a year-long study is around $2000, as long as all visits have been attended. Payments are made throughout the course of the study, not prior to participation. The last payment typically includes a bonus if no visits have been missed. Volunteers are not paid for missed visits and you may be removed from the study for missing more than one follow-up visit.

How do I know that this vaccine is safe?
All clinical trials, including vaccine development studies, are designed to be as safe as possible for human volunteers. However, there are risks involved in participation in any clinical study. Often, one of the objectives of studies is to evaluate the medication, biologic or vaccine for safety, efficacy and effectiveness. In the development of most medications or vaccines, the products will have first been tested in animals and safety has been evaluated before being tested in healthy adults.

In addition, before a new “investigational product” (medication, biological, vaccine) is given to humans, its use must be approved by the U.S. Food and Drug Administration (FDA). Following approval by the FDA, the study must be approved by the University’s Institutional Review Board, (IRB), a committee that consists of physicians, pharmacists, nurses, other scientists, and community members, who are “responsible for reviewing and overseeing all research activities in order to ensure protection of individuals who participate in research projects.”  The IRB requires that each study lists all known potential risks in an “informed consent form,” which must be read, understood, and signed by the volunteer before study participation. Studies that require hospital stays are also approved by the research unit, the Clinical Research Center (CRC).

Complicated studies also have a safety oversight group which reviews data on an interim basis as another check for subject safety.

It is important to know that approvals by safety and ethics committees cannot eliminate risk in human studies. The individual volunteer must read and understand the potential risks in each trial and determine for themselves whether they would like to participate.

What if I decide I don’t want to continue in the study after I’ve signed the informed consent?
You are free to leave the study at any time. If you have received a medication, vaccine or biologic product, however, the study team will request that they are able to contact you to be sure you remain healthy.

Does everyone receive the vaccine?
No. Each study is different. In some studies a placebo or sham medication is used. A volunteer may receive the vaccine or may receive a placebo. This would be explained before you signed a consent to participate in any study activity.

Will I be told whether I received the vaccine or placebo? If so, when?

This is different with each study and would be explained to you before the consent is signed.

How can I sign up?
Contact the Vaccine Testing Center at 802-656-0013, email or fill out our online contact form and we'll get in touch. You will need to go through a phone screening with the recruiter, which typically takes about 15 minutes. If you pass the phone screening requirements, you may then schedule an in-person screening appointment.

What will happen at the screening appointment?

First, the volunteer will learn about the study’s goals and requirements, have an opportunity to ask questions, and read and sign the informed consent form if interested in participating. Second, the screening process is used to determine if you are eligible to be in the study. The study team (coordinators, nurses, doctors) will ask you questions about your medical history, perform a brief physical exam and obtain samples for blood and/or urine testing. The blood and urine testing will help ensure that you are healthy and qualify for the study. In most studies, it is standard for volunteers to be checked for the viruses that cause hepatitis B and C, and HIV.

If I am eligible after attending the screening appointment and would like to participate, what happens next?
After the end of the screening visit, the study team will contact the volunteer to review the laboratory data. If the volunteer qualifies and is chosen to participate, they will be scheduled for the dosing day.

What can I expect at dosing day?
Dosing day includes review of the study and a subject’s eligibility followed by a brief physical exam and blood draw and/or urine testing.  Following these pre-dosing procedures, you will receive either the vaccine or a placebo either as an injection in your upper arm or as an oral vaccine, depending on the type of vaccine being studied. You are required to stay for 30 minutes for observation and education post vaccination. The dosing day visit typically lasts about two hours.

What happens after dosing day?
After the dosing day, subjects will be expected to return to the research clinic for follow up visits.  The number of visits and duration of each visit varies depending the study.  Most visits last 30 minutes.  Some studies also require subjects to complete a diary of any symptoms they have after vaccination and/or record their temperature. 

 

Man getting blood pressure taken

News of Note

Dengvaxia, the Sanofi-Pasteur dengue vaccine currently in use in a number of dengue endemic countries, recently underwent relabeling This is not the same vaccine as the one being tested at UVM. Learn more about the vaccines here.

Have questions? We're here to help.

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