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

NCT05701800 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: mRNA-1468-P101
• Study Type: interventional
• Target: 659
• Locations: 2 countries
• Sites: 20

Brief Summary

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

Conditions

Herpes Zoster

Keywords

mRNA-1468; Herpes Zoster vaccine; Moderna

Outcome Measures

Primary Outcomes (4)

• Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions

  Up to Day 64 (7 days after each injection)

• Number of Participants with Unsolicited Adverse Events (AEs)

  Up to Day 85 (28 days after each injection)

• Number of Participants with Serious AEs, AEs Leading to Discontinuation of Study Vaccine or Withdrawal From the Study, and AEs of Special Interest

  Day 1 to End of Study (up to a maximum of Day 1113)

• Number of Participants with Medically Attended AEs

  Day 1 to Day 393 (12 months after last study injection)

Secondary Outcomes (3)

• Vaccine Seroresponse Rate of Participants

  Day 85 and Day 225 (1 and 6 months after the last injection)

• Geometric Mean Concentration of Anti-gE-specific bAb as Measured by Enzyme-linked Immunosorbent Assay

  Day 85 and Day 225 (1 and 6 months after the last injection)

• Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Concentration

  Baseline, Day 85 and Day 225 (1 and 6 months after the last injection)

Study Arms (8)

Part 1: mRNA-1468: Dose 1

EXPERIMENTAL

Participants will receive placebo by intramuscular (IM) injection on Day 1 followed with mRNA-1468 by IM injection on Day 57 in Part 1.

Biological: mRNA-1468; Biological: Placebo

Part 1: mRNA-1468: Dose 2

EXPERIMENTAL

Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.

Biological: mRNA-1468

Part 1: mRNA-1468: Dose 3

EXPERIMENTAL

Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.

Biological: mRNA-1468

Part 1: mRNA-1468: Dose 4

EXPERIMENTAL

Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.

Biological: mRNA-1468

Part 1: Shingrix

ACTIVE COMPARATOR

Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 1.

Biological: Shingrix

Part 2: mRNA-1468: Dose 5

EXPERIMENTAL

Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.

Biological: mRNA-1468

Part 2: mRNA-1468: Dose 6

EXPERIMENTAL

Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.

Biological: mRNA-1468

Part 2: Shingrix

ACTIVE COMPARATOR

Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 2.

Biological: Shingrix

Interventions

mRNA-1468 BIOLOGICAL

Sterile liquid dispersion for injection

Part 1: mRNA-1468: Dose 1; Part 1: mRNA-1468: Dose 2; Part 1: mRNA-1468: Dose 3; Part 1: mRNA-1468: Dose 4; Part 2: mRNA-1468: Dose 5; Part 2: mRNA-1468: Dose 6

Placebo BIOLOGICAL

Sterile liquid for injection

Also known as: Saline

Part 1: mRNA-1468: Dose 1

Shingrix BIOLOGICAL

Sterile suspension for injection

Part 1: Shingrix; Part 2: Shingrix

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1: Is an adult 50 years of age or older at the time of consent. Part 2: Is an adult 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 Screening Visit and on the day of the first vaccination (Day 1); have practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1; have agreed to continue adequate contraception through 3 months following vaccine administration; are not currently breastfeeding.

You may not qualify if:

• 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 the Screening Visit or on Day 1. Participants meeting this criterion may be rescheduled within the allowed window.
• Has a current or previous diagnosis of congenital or acquired immunodeficiency, immunocompromizing/immunosuppressive condition, asplenia, or recurrent severe infections. Certain immune-mediated conditions that are well controlled and stable (for example, Hashimoto thyroiditis) as well as those that do not require systemic immunosuppressive therapy (for example, asthma, psoriasis, or vitiligo) may be permitted at the discretion of the Investigator.
• Has a dermatologic condition that could affect local solicited adverse reaction assessments (for example, tattoos, psoriasis patches affecting skin over the deltoid areas).
• Has any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
• Has a history of myocarditis, pericarditis, or myopericarditis.
• Has a reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines.
• Has received systemic immunosuppressants for \>14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, intra-articular and topical steroids are allowed.
• Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, Infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (20)

Velocity Clinical Research - Westlake

Los Angeles, California, 90057, United States

Location

Tekton Research, Inc - Longmont Center

Longmont, Colorado, 80501, United States

Location

Meridien Research

Lakeland, Florida, 33805, United States

Location

Clinical Trials of Florida, LLC

Miami, Florida, 33186, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, 32789, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Great Lakes

Chicago, Illinois, 60640, United States

Location

DM Clinical Research- River Forest

River Forest, Illinois, 60305, United States

Location

Meridian Clinical Research - Dakota Dunes

Sioux City, Iowa, 51106, United States

Location

Johnson County Clin-Trials (JCCT)

Lenexa, Kansas, 66219, United States

Location

NOLA Research Works

New Orleans, Louisiana, 70115, United States

Location

Velocity Clinical Research - Medford

Medford, Oregon, 97504, United States

Location

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

Gadolin Research

Beaumont, Texas, 77702, United States

Location

LinQ Research, LLC

Houston, Texas, 77087, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Research Works San Juan

San Juan, 00907, Puerto Rico

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: January 23, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

PR (1); US (19)