A clinical trial of an investigational shingles vaccine for adults over 50

Trial ID: mRNA-1468-P101

The Zone Trial is a Phase 1/2 clinical trial conducted by Moderna to evaluate an investigational vaccine, mRNA-1468, which was developed to protect adults ages 50 and up from herpes zoster (HZ), also known as shingles. According to the Centers for Disease Control, HZ affects more than 1 million people per year in the United States and approximately 1 in 3 persons will develop HZ in their lifetime.

Trial Details

The purpose of the Zone Trial is to evaluate the safety of and immune response to an investigational vaccine, called mRNA-1468, for protecting against herpes zoster (HZ), otherwise known as shingles, in adults ages 70 and up.

Varicella-zoster virus, or VZV, is the virus that causes chickenpox. If an individual has had chickenpox in the past, it is possible for the VZV virus to reactivate in their body and cause shingles. This is most common in adults over the age of 50, and often manifests as a burning or throbbing rash that usually lasts for a few weeks.

About 500 participants will be enrolled into the Zone Trial. Participants will receive the investigational vaccine or an existing shingles vaccine.

Estimated Enrollment

Approx. 500 participants Participants

Phase

1/2

Eligibility Criteria

Participants must:

Be 70 years of age or older
Be in generally good health

Participants must not:

Have had shingles within the past 10 years
Have been vaccinated against chickenpox or shingles previously

Site Locations

Sites are located in the cities/states identified with the red pin:

What to Expect

Participation in the Zone Trial will last approximately 15 months and includes 10 visits to a trial site and up to 8 safety phone calls.

Participants will be given 2 injections in the upper arm and will be chosen at random to receive either the investigational vaccine or the existing shingles vaccine. By comparing the investigational vaccine to one that is already approved and circulated, medical researchers can better understand how well the investigational vaccine works.

All trial participants will receive the same level of quality care regardless of whether they are assigned to the investigational vaccine or the currently available shingles vaccine.

Participants will have 8 phone calls with the trial staff after their injections to monitor for any side effects.

Participants will be asked to use an eDiary app on their smartphone or a provided smartphone to report any side effects they might experience for 1 week after each injection.

Insurance is not needed to participate, and qualified participants will receive payment for their trial-related time and travel.

Frequently Asked Questions (FAQs)

What is shingles?

Herpes zoster (HZ), also known as shingles, is caused by the varicella-zoster virus, the virus that also causes chickenpox. The majority of shingles cases resolve in three to five weeks. However, the most common complication of HZ is postherpetic neuralgia (PHN), characterized by the persistence of pain for longer than three months following the onset of HZ rash. Affected individuals may experience pain described as stabbing, burning, or throbbing. PHN usually resolves within a year, but in rare cases, symptoms can last for many years. The Centers for Disease Control estimates that HZ affects more than 1 million people per year in the United States and that approximately 1 in 3 persons will develop HZ in their lifetime. The risk of HZ increases significantly with age, with about half of cases occurring in individuals over the age of 60.

What is a clinical trial?

Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer questions such as:

Is the investigational treatment or vaccine safe enough to outweigh the risks?
What is the best dose needed for the investigational treatment or vaccine to work?
How often should the investigational treatment or vaccine be given?
How effective is the investigational treatment or vaccine at treating or preventing symptoms or the condition?

A clinical trial follows a protocol that has been approved by regulatory agencies to ensure patients’ and trial participants’ safety. The protocol outlines the types of trial participants to include, the schedule of visits and procedures, safety precautions, and what and how data will be analyzed.

What are the phases of clinical trials?

Clinical trials are conducted in phases. Each phase of the trial has a different purpose and helps scientists answer different questions:

In Phase 1 trials, researchers test a new vaccine, drug, or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the investigational vaccine, drug, or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the investigational vaccine, drug, or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

Reference: https://www.ciscrp.org/education-center/important-information/#faq

Why is diversity important in clinical trials?

Clinical trials and trial volunteers are vital to advancing research of an investigational vaccine that may potentially protect people of all ages and from all backgrounds.

Given that different populations and ages can respond differently to medical therapies, it is extremely important that this clinical trial include people of all ages, sexes, races, and ethnicities to ensure the investigational vaccine is safe and effective for everyone to use.

Will compensation for time be available as part of this clinical trial?

Compensation for your trial-related time may be provided.

Does the mRNA-1468 investigational vaccine contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1468 investigational vaccine is different. It is made from an instructional molecule called mRNA that tells your cells how to make protein. In this case, the protein is a small part of the virus that will hopefully help the body’s immune system protect itself if you ever come in contact with the varicella-zoster virus. You cannot get shingles from the mRNA-1468 investigational vaccine.

How can I check to see if I am eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Can I remove myself from the trial at any time?

Participation is voluntary. You have the right to end your participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements.

This trial is not actively recruiting.