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

Primary Purpose

Herpes Zoster

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
mRNA-1468
Placebo
Shingrix
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring mRNA-1468, Herpes Zoster vaccine, Moderna

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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, immunocompromising/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.

Sites / Locations

  • Velocity Clinical Research - Westlake
  • Tekton Research, Inc - Longmont Center
  • Meridien Research
  • Floridian Clinical Research
  • Clinical Trials of Florida, LLC
  • Florida Pulmonary Research Institute, LLC
  • Centricity Research
  • Great Lakes
  • DM Clinical Research- River Forest
  • Meridian Clinical Research - Dakota Dunes
  • Johnson County Clin-Trials (JCCT)
  • NOLA Research Works
  • Velocity Clinical Research - Medford
  • DM Clinical Research - Philadelphia
  • WR-ClinSearch, LLC
  • Tekton Research
  • Gadolin Research
  • LinQ Research, LLC
  • DM Clinical Research
  • Research Works San Juan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

mRNA-1468: Dose 1

mRNA-1468: Dose 2

mRNA-1468: Dose 3

mRNA-1468: Dose 4

Shingrix

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants with Serious AEs, Medically Attended AEs, AEs Leading to Discontinuation of Study Vaccine or Withdrawal From the Study, and AEs of Special Interest

Secondary Outcome Measures

Geometric Mean Titer of Anti-glycoprotein E (gE)-specific Binding Antibodies (bAb) as Measured by Enzyme-linked Immunosorbent Assay
Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Titer
Vaccine Seroresponse Rate of Participants
Vaccine seroresponse will be defined as an anti-gE-specific bAb titer ≥4-fold if baseline bAb titer is above the lower limit of quantification (LLOQ) or ≥4 * LLOQ if baseline bAb titer is <LLOQ prior to vaccination.

Full Information

First Posted
January 18, 2023
Last Updated
July 5, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05701800
Brief Title
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of Age
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
July 8, 2024 (Anticipated)
Study Completion Date
July 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main purpose of this first-in-human study is to generate sufficient safety and immunogenicity data to enable the selection of an appropriate dose level for the initiation of a Phase 2/3 study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
mRNA-1468, Herpes Zoster vaccine, Moderna

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1468: Dose 1
Arm Type
Experimental
Arm Description
Participants will receive placebo by intramuscular (IM) injection on Day 1 followed with mRNA-1468 by IM injection on Day 57.
Arm Title
mRNA-1468: Dose 2
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57.
Arm Title
mRNA-1468: Dose 3
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57.
Arm Title
mRNA-1468: Dose 4
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57.
Arm Title
Shingrix
Arm Type
Active Comparator
Arm Description
Participants will receive Shingrix by IM injection on Day 1 and Day 57.
Intervention Type
Biological
Intervention Name(s)
mRNA-1468
Intervention Description
Sterile liquid dispersion for injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
Shingrix
Intervention Description
Sterile suspension for injection
Primary Outcome Measure Information:
Title
Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
Time Frame
Up to Day 64 (7 days after each injection)
Title
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 85 (28 days after each injection)
Title
Number of Participants with Serious AEs, Medically Attended AEs, AEs Leading to Discontinuation of Study Vaccine or Withdrawal From the Study, and AEs of Special Interest
Time Frame
Up to Day 393 (Month 14)
Secondary Outcome Measure Information:
Title
Geometric Mean Titer of Anti-glycoprotein E (gE)-specific Binding Antibodies (bAb) as Measured by Enzyme-linked Immunosorbent Assay
Time Frame
Day 85 (1 month after injection)
Title
Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Titer
Time Frame
Baseline, Day 85 and Day 225 (1 and 6 months after each injection)
Title
Vaccine Seroresponse Rate of Participants
Description
Vaccine seroresponse will be defined as an anti-gE-specific bAb titer ≥4-fold if baseline bAb titer is above the lower limit of quantification (LLOQ) or ≥4 * LLOQ if baseline bAb titer is <LLOQ prior to vaccination.
Time Frame
Day 85 and Day 225 (6 months after each injection)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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, immunocompromising/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.
Facility Information:
Facility Name
Velocity Clinical Research - Westlake
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Tekton Research, Inc - Longmont Center
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Meridien Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Floridian Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Clinical Trials of Florida, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Florida Pulmonary Research Institute, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Centricity Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Great Lakes
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
DM Clinical Research- River Forest
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Meridian Clinical Research - Dakota Dunes
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Facility Name
Johnson County Clin-Trials (JCCT)
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
NOLA Research Works
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Velocity Clinical Research - Medford
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
DM Clinical Research - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
WR-ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Gadolin Research
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
LinQ Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Research Works San Juan
City
San Juan
ZIP/Postal Code
00907
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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