Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05701800

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Works San Juan, San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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.

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

mRNA-1468

Biological

Sterile liquid dispersion for injection

Placebo

Biological

Sterile liquid for injection

Other names: Saline

Shingrix

Biological

Sterile suspension for injection

Primary outcomes

  1. Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions

    Time frame: Up to Day 64 (7 days after each injection)

  2. Number of Participants with Unsolicited Adverse Events (AEs)

    Time frame: Up to Day 85 (28 days after each injection)

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

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

  4. Number of Participants with Medically Attended AEs

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

Secondary outcomes

  1. Vaccine Seroresponse Rate of Participants

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

    Vaccine seroresponse will be defined as an anti-glycoprotein E (gE)-specific binding antibody (bAb) concentration ≥4-fold if baseline bAb concentration is above the lower limit of quantification (LLOQ) or ≥4 * LLOQ if baseline bAb concentration is <LLOQ prior to vaccination.

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

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

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

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

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

A Phase 1/2, Randomized, Observer-Blind, Active-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity and Immunogenicity of mRNA-1468, a Candidate Vaccine to Prevent Herpes Zoster (HZ) in Healthy Adults ≥50 Years of Age

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2023
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.