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
Status: Active_not_recruiting
Location: See all (20) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The purpose of this first-in-human study is to evaluate the safety and immunogenicity of mRNA-1468.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:
• 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.
Locations
United States
California
Velocity Clinical Research - Westlake
Los Angeles
Colorado
Tekton Research, Inc - Longmont Center
Longmont
Florida
Meridien Research
Lakeland
Clinical Trials of Florida, LLC
Miami
Floridian Clinical Research
Miami Lakes
Florida Pulmonary Research Institute, LLC
Winter Park
Georgia
Centricity Research
Columbus
Iowa
Meridian Clinical Research - Dakota Dunes
Sioux City
Illinois
Great Lakes
Chicago
DM Clinical Research- River Forest
River Forest
Kansas
Johnson County Clin-Trials (JCCT)
Lenexa
Louisiana
NOLA Research Works
New Orleans
Oregon
Velocity Clinical Research - Medford
Medford
Pennsylvania
DM Clinical Research - Philadelphia
Philadelphia
Tennessee
WR-ClinSearch, LLC
Chattanooga
Texas
Tekton Research
Austin
Gadolin Research
Beaumont
LinQ Research, LLC
Houston
DM Clinical Research
Tomball
Other Locations
Puerto Rico
Research Works San Juan
San Juan
Time Frame
Start Date: 2023-01-23
Completion Date: 2026-06-30
Participants
Target number of participants: 659
Treatments
Experimental: Part 1: mRNA-1468: Dose 1
Participants will receive placebo by intramuscular (IM) injection on Day 1 followed with mRNA-1468 by IM injection on Day 57 in Part 1.
Experimental: Part 1: mRNA-1468: Dose 2
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
Experimental: Part 1: mRNA-1468: Dose 3
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
Experimental: Part 1: mRNA-1468: Dose 4
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
Active_comparator: Part 1: Shingrix
Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 1.
Experimental: Part 2: mRNA-1468: Dose 5
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.
Experimental: Part 2: mRNA-1468: Dose 6
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.
Active_comparator: Part 2: Shingrix
Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 2.
Related Therapeutic Areas
Sponsors
Leads: ModernaTX, Inc.