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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



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)