Herpes ZosterPhase 1NCT05701800
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of Age
A Phase 1 study testing mRNA-1468 and Shingrix in people with Herpes Zoster, run by ModernaTX, Inc. at 20 sites in 2 countries.
Trial summary
The purpose of this first-in-human study is to evaluate the safety and immunogenicity of mRNA-1468. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- mRNA-1468 and Shingrix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 659 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 23 Jan 2023to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States19 sites
Tekton Research
Austin, Texas, 78745
Gadolin Research
Beaumont, Texas, 77702
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421
Great Lakes
Chicago, Illinois, 60640
Centricity Research
Columbus, Georgia, 31904
LinQ Research, LLC
Houston, Texas, 77087
Meridien Research
Lakeland, Florida, 33805
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219
Tekton Research, Inc - Longmont Center
Longmont, Colorado, 80501
Velocity Clinical Research - Westlake
Los Angeles, California, 90057
Velocity Clinical Research - Medford
Medford, Oregon, 97504
Clinical Trials of Florida, LLC
Miami, Florida, 33186
Floridian Clinical Research
Miami Lakes, Florida, 33016
NOLA Research Works
New Orleans, Louisiana, 70115
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107
DM Clinical Research- River Forest
River Forest, Illinois, 60305
Meridian Clinical Research - Dakota Dunes
Sioux City, Iowa, 51106
DM Clinical Research
Tomball, Texas, 77375
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789
About this study
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
The purpose of this first-in-human study is to evaluate the safety and immunogenicity of mRNA-1468.
- Conditions
- Herpes Zoster
- Being tested
- mRNA-1468, Placebo, Shingrix
- Keywords
- mRNA-1468, Herpes Zoster vaccine, Moderna
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1468Biological
Sterile liquid dispersion for injection
PlaceboBiological
Also called Saline
Sterile liquid for injection
ShingrixBiological
Sterile suspension for injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: mRNA-1468 |
| Part 1: Shingrix | Active comparator | Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 1. Receives: 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. Receives: 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. Receives: Biological: mRNA-1468 |
| Part 2: Shingrix | Active comparator | Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 2. Receives: Biological: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
Measured: Up to Day 64 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: 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
Measured: Day 1 to End of Study (up to a maximum of Day 1113)
Number of Participants with Medically Attended AEs
Measured: Day 1 to Day 393 (12 months after last study injection)
Secondary outcomes (3)
Vaccine Seroresponse Rate of Participants
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.
Measured: 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
Measured: 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
Measured: Baseline, Day 85 and Day 225 (1 and 6 months after the last injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start23 Jan 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: The clinical study was terminated prior to the start of Phase 2 following a business decision to discontinue further development of the vaccine.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701800
- Sponsor's protocol ID
- mRNA-1468-P101
- Status last verified
- Aug 2026
- First submitted
- 18 Jan 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05701800
- Acronym / sponsor ID
- mRNA-1468-P101
- Conditions
- Herpes Zoster
- Keywords
- mRNA-1468, Herpes Zoster vaccine, Moderna
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical study was terminated prior to the start of Phase 2 following a business decision to discontinue further development of the vaccine.
- Enrolment
- 659 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this first-in-human study is to evaluate the safety and immunogenicity of mRNA-1468.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: mRNA-1468: Dose 1 | Experimental | Biological: mRNA-1468, Biological: PlaceboParticipants will receive placebo by intramuscular (IM) injection on Day 1 followed with mRNA-1468 by IM injection on Day 57 in Part 1. |
| Part 1: mRNA-1468: Dose 2 | Experimental | Biological: mRNA-1468Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1. |
| Part 1: mRNA-1468: Dose 3 | Experimental | Biological: mRNA-1468Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1. |
| Part 1: mRNA-1468: Dose 4 | Experimental | Biological: mRNA-1468Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1. |
| Part 1: Shingrix | Active comparator | Biological: ShingrixParticipants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 1. |
| Part 2: mRNA-1468: Dose 5 | Experimental | Biological: mRNA-1468Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2. |
| Part 2: mRNA-1468: Dose 6 | Experimental | Biological: mRNA-1468Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2. |
| Part 2: Shingrix | Active comparator | Biological: ShingrixParticipants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 2. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1468Sterile liquid dispersion for injection | Biological | 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 |
| PlaceboAlso: SalineSterile liquid for injection | Biological | Part 1: mRNA-1468: Dose 1 |
| ShingrixSterile suspension for injection | Biological | Part 1: Shingrix, Part 2: Shingrix |
Primary outcome
Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
Time frame: Up to Day 64 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: 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
Time frame: Day 1 to End of Study (up to a maximum of Day 1113)
Number of Participants with Medically Attended AEs
Time frame: Day 1 to Day 393 (12 months after last study injection)
3 secondary outcomes
Vaccine Seroresponse Rate of Participants
Time frame: 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
Time frame: 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
Time frame: Baseline, Day 85 and Day 225 (1 and 6 months after the last injection)
Results and safety
The study was stopped early (reason given: The clinical study was terminated prior to the start of Phase 2 following a business decision to discontinue further development of the vaccine.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-1468 and Shingrix in people with Herpes Zoster, run by ModernaTX, Inc. at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The clinical study was terminated prior to the start of Phase 2 following a business decision to discontinue further development of the vaccine.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (time frame: Up to Day 64 (7 days after each injection)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.