A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of Age

Last updated: August 12, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Shingles

Chickenpox (Varicella Zoster Infection)

Herpes Simplex Infections

Treatment

Placebo

mRNA-1468

Shingrix

Clinical Study ID

NCT05701800
mRNA-1468-P101
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this first-in-human study is to evaluate the safety and immunogenicity of mRNA-1468.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Part 1: Is an adult 50 years of age or older at the time of consent. Part 2: Is anadult 50-69 years of age at the time of consent.

  • Has a body mass index of 18 to <40 kilograms/meter squared at the Screening Visit.

  • Females of childbearing potential: have a negative pregnancy test at the ScreeningVisit and on the day of the first vaccination (Day 1); have practiced adequatecontraception or has abstained from all activities that could result in pregnancyfor at least 28 days prior to Day 1; have agreed to continue adequate contraceptionthrough 3 months following vaccine administration; are not currently breastfeeding.

Exclusion

Exclusion Criteria:

  • Has a history of HZ within the past 10 years.

  • Has been previously vaccinated against varicella or HZ.

  • Is acutely ill or febrile

  • Body temperature ≥38.0°Celsius/100.4°Fahrenheit 72 hours prior to or at theScreening Visit or on Day 1. Participants meeting this criterion may be rescheduledwithin the allowed window.

  • Has a current or previous diagnosis of congenital or acquired immunodeficiency,immunocompromizing/immunosuppressive condition, asplenia, or recurrent severeinfections. Certain immune-mediated conditions that are well controlled and stable (for example, Hashimoto thyroiditis) as well as those that do not require systemicimmunosuppressive therapy (for example, asthma, psoriasis, or vitiligo) may bepermitted at the discretion of the Investigator.

  • Has a dermatologic condition that could affect local solicited adverse reactionassessments (for example, tattoos, psoriasis patches affecting skin over the deltoidareas).

  • Has any medical, psychiatric, or occupational condition, including reported historyof substance abuse, that, in the opinion of the Investigator, might pose additionalrisk due to participation in the study or could interfere with the interpretation ofstudy results.

  • Has a history of myocarditis, pericarditis, or myopericarditis.

  • Has a reported history of anaphylaxis or severe hypersensitivity reaction afterreceipt of any mRNA vaccine(s) or any components of the mRNA vaccines.

  • Has received systemic immunosuppressants for >14 days in total within 180 days priorto Screening Visit (for corticosteroids ≥10 milligrams/day of prednisone orequivalent) or is anticipating the need for systemic immunosuppressive treatment atany time during participation in the study. Inhaled, nasal, intra-articular andtopical steroids are allowed.

  • Has received systemic immunoglobulins, long-acting biological therapies that affectimmune responses (for example, Infliximab) or blood products within 90 days prior tothe Screening Visit or plans to receive them during the study.

Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 659
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
January 23, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Research Works San Juan

    San Juan, 00907
    Puerto Rico

    Site Not Available

  • Velocity Clinical Research - Westlake

    Los Angeles, California 90057
    United States

    Site Not Available

  • Tekton Research, Inc - Longmont Center

    Longmont, Colorado 80501
    United States

    Site Not Available

  • Meridien Research

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Clinical Trials of Florida, LLC

    Miami, Florida 33186
    United States

    Site Not Available

  • Floridian Clinical Research

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Florida Pulmonary Research Institute, LLC

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Centricity Research

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Great Lakes

    Chicago, Illinois 60640
    United States

    Site Not Available

  • DM Clinical Research- River Forest

    River Forest, Illinois 60305
    United States

    Site Not Available

  • Meridian Clinical Research - Dakota Dunes

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Johnson County Clin-Trials (JCCT)

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • NOLA Research Works

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Velocity Clinical Research - Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Tekton Research

    Austin, Texas 78745
    United States

    Site Not Available

  • Gadolin Research

    Beaumont, Texas 77702
    United States

    Site Not Available

  • LinQ Research, LLC

    Houston, Texas 77087
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

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