Frequently Asked Questions about the West Nile Vaccine Study
What is a clinical research study/trial?
A clinical trial evaluates the effectiveness and safety of a new medication by monitoring its effects 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 determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.
Who can participate?
Currently, we are looking for basically healthy individuals, between the ages of 50-65 as of dosing day.
What is the time commitment ?
We are currently recruiting for a year-long West Nile vaccine study which includes:
- one two-hour screening appointment
- two two-hour dosing appointments, six months apart
- 24 thirty-minute follow up appointments
Will I receive any compensation?
You will receive some compensation for your time and travel. Typical compensation for a year-long study, as long as all visits have been attended, is around $2,300. Payments are made throughout the course of the study. The last payment typically includes a bonus as long as no visits have been missed. Volunteers are not paid for missed visits, and you could 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 many studies is to show that the medication/biologic or vaccine is safe in humans. In the development of most medications or vaccines, these products will have first been confirmed to be safe in animals, and then tested in healthy populations of adults before being further used or tested in ill individuals or children.
In addition, before any new “investigational product” (medication, biological, vaccine) is given to any human, its use must be approved first by the U.S. Food and Drug Administration (FDA) under an Investigational New Drug (IND) application/protocol. 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, as well as community members “responsible for reviewing and overseeing all research activities in order to ensure the protection of individuals who participate in research projects.” The IRB requires that each study list 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).
In addition, complicated studies also have an internal 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 volunteer.
Will I contract West Nile Virus from this experimental vaccine?
No. We use a live attenuated virus, which elicits an immune response but does not give you West Nile Virus.
Does everyone receive the vaccine?
No. Some volunteers will receive the vaccine and some will receive a placebo. You will be sent an unblinding letter before the conclusion of the study informing you of which you received.
How can I sign up?
Contact the Vaccine Testing Center at 802-656-0013 or via email at email@example.com. You will need to go through a phone screening with one of the recruiters, which typically takes about 15 minutes. If you pass through the phone screening requirements, you may then schedule a screening appointment.
What will happen at the screening appointment?
The screening appointment takes about two hours and has two objectives: First is for the volunteer to learn about the study’s goals and requirements, to ask questions, and finally to read and sign the “informed consent” if they are 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, as well as HIV.
If I am eligible after attending the screening appointment, and would like to participate, what 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, s/he will be scheduled for the dosing day visit.
What can I expect on dosing day?
Dosing day includes a physical, a blood draw and/or urine testing, and then you will receive either the vaccine or a placebo as an injection in your upper arm. You are required to stay for 30 minutes for observation and education post vaccination. The dosing day visit typically lasts about two hours.
What if I decide I don't want to continue in the study after I have signed 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 would like to stay in touch with you as much as possible to be sure that you continue to be safe and healthy.
How can I do my own research on West Nile Virus before I call?
We encourage our volunteers to come to their screening appointment prepared to ask as many questions as needed. Explore these websites for more information on West Nile Virus:
- World Health Organization (WHO)
- National Institutes for Health (NIH)
- Centers for Disease Control (CDC)
Last modified March 28 2014 01:27 PM