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> Record changed: 2026-10-13

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

NCT05701800

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

Recruitment status

Terminated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

Participants

659

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

Lead sponsor

ModernaTX, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

Start date

2023-01-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

Number of sites

20

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Title and summary

**Summary**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Official 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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Recruitment status**

Terminated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Reason stopped**

The clinical study was terminated prior to the start of Phase 2 following a business decision to discontinue further development of the vaccine.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Dates

**Completion date**

2025-12-31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**First posted**

2023-01-27

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Registry last updated**

2026-08-05

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Primary completion date**

2025-12-31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Start date**

2023-01-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Size and sites

**Actual participants**

659

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Participants**

659

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Protocol amendments**

5

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Number of sites**

20

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Sponsor and oversight

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Lead sponsor**

ModernaTX, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Identifiers

**Registry ID**

NCT05701800

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**ClinicalTrials.gov ID**

NCT05701800

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Triple masking

**Masked roles**

Participants, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Outcomes

### Primary outcomes

1. Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions  
Timeframe: Up to Day 64 (7 days after each injection)
2. Number of Participants with Unsolicited Adverse Events (AEs)  
Timeframe: 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  
Timeframe: Day 1 to End of Study (up to a maximum of Day 1113)
4. Number of Participants with Medically Attended AEs  
Timeframe: Day 1 to Day 393 (12 months after last study injection)

### Secondary outcomes

1. Vaccine Seroresponse Rate of Participants  
Timeframe: 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  
Timeframe: 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  
Timeframe: Baseline, Day 85 and Day 225 (1 and 6 months after the last injection)

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

50 Years

**Healthy volunteers**

Yes

### 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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Sites

- Velocity Clinical Research - WestlakeLos Angeles, United States
- Tekton Research, Inc - Longmont CenterLongmont, United States
- Meridien ResearchLakeland, United States
- Clinical Trials of Florida, LLCMiami, United States
- Floridian Clinical ResearchMiami Lakes, United States
- Florida Pulmonary Research Institute, LLCWinter Park, United States
- Centricity ResearchColumbus, United States
- Great LakesChicago, United States
- DM Clinical Research- River ForestRiver Forest, United States
- Meridian Clinical Research - Dakota DunesSioux City, United States
- Johnson County Clin-Trials (JCCT)Lenexa, United States
- NOLA Research WorksNew Orleans, United States
- Velocity Clinical Research - MedfordMedford, United States
- DM Clinical Research - PhiladelphiaPhiladelphia, United States
- WR-ClinSearch, LLCChattanooga, United States
- Tekton ResearchAustin, United States
- Gadolin ResearchBeaumont, United States
- LinQ Research, LLCHouston, United States
- DM Clinical ResearchTomball, United States
- Research Works San JuanSan Juan, Puerto Rico

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05701800)

## Related records

### Drugs (1)

- [Varicella zoster virus envelope glycoprotein E](https://trialight.com/data/asset/varicella-zoster-virus-envelope-glycoprotein-e-ff6f0103-e6e7-4f17-9aed-0ca05c8633ef.md)

### Lead sponsors (1)

- [ModernaTX, Inc.](https://trialight.com/data/company/modernatx-inc-8ece6782-e44c-4999-be6a-0b94e61dfff5.md)

### Conditions (1)

- [Herpes zoster](https://trialight.com/data/condition/herpes-zoster-b5c04cf4-ae28-5154-8254-f4f1fde4c3c9.md) Primary condition

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