JCCT 167

A PHASE 1/2 RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST VARICELLA ZOSTER VIRUS IN HEALTHY INDIVIDUALS
50 - 69 / Male or Female / Earn up to $1,875

About the Study

Shingles (also known as herpes zoster) is a painful skin rash caused by varicella zoster virus (VZV), the virus that causes chickenpox. Shingles can develop in people years after they had chickenpox. Around 1 in 3 people will develop shingles during their lifetime. The risk of developing shingles is highest in older adults.

Although there are licensed vaccines available to help prevent shingles, these vaccines may have some limitations. For example, some of the licensed vaccines may not be widely available in some countries or may have more side effects than seen with other vaccines that are given to adults.

The purpose of this study is to see if a new type of investigational VZV vaccine, called Varicella Zoster Virus modRNA Vaccine (VZV modRNA vaccine), is safe and can prompt the body to produce antibodies which may help prevent shingles. The term “investigational vaccine” means that it has not yet been approved by health authorities. As VZV modRNA vaccine is an investigational vaccine, we need to test 3 different candidates or versions of VZV modRNA vaccine to find out which candidate, dose level (strength) and dosing schedule will work best. The safety and tolerability information about the vaccine used in this study, meaning the type and frequency of any possible side effects, will be collected and evaluated throughout the study.

Qualifications

Are you between 50-69?

Have you been diagnosed with shingles?

Have you received a shingles or chicken pox vaccine?

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Frequently asked questions

View all FAQs

What is a screening visit?

A screening visit is your first visit to our facility and takes roughly 2-4 hours. After filling out paperwork and reviewing a consent form, one of our nurses will go over the details to ensure your understanding.
This is the perfect time to ask any questions about the study and how your participation will affect you.
The nurse will then go over your medical history and take vitals.
The next step is completing a physical with our doctor. If our doctor deems you healthy enough for the study, you will then see our phlebotomist for a blood draw.

How do I prepare for my screening visit?

The night before:

  • Hydrate, hydrate, hydrate!
  • Avoid a large consumption of alcohol
  • Avoid sugary foods and drinks

The morning of:

  • Continue to hydrate well
  • Eat a light, healthy breakfast (Examples: bagels, scrambled eggs, yogurt, fruit, whole grain cereal)
  • Bring a photo ID
  • Make sure you have a form of entertainment (Examples: Books, magazines, mobile video game systems, laptops, etc.)

What questions should I ask the nurse?

First, you can ask our nurses any questions that come to your mind at any point of the process. But some good examples are:

  • Has this new medication/vaccine been tested on humans before?
  • What is the purpose of this new medication/vaccination?
  • What are the risks involved?
  • What company developed the medication/vaccine?
  • What is the procedure?
  • How/What samples are collected?
  • How long is the trial?

What is informed consent?

Informed consent is the process of our volunteers being given all the information about the study. For your protection, all clinical trial facilities MUST give you all the details (including risks and benefits) pertaining to the study before you give consent to volunteer. All volunteers must sign the informed consent before they can participate in a trial. As the study progresses, there could be additional informed consent forms that require your signature.

JCCT takes this process very seriously. You will be given 1 on 1 time with one of our nurses to go over the consent form and ask as many questions as you need before you sign.