Clinical trial NCT05701800: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Herpes Zoster
Keywords: mRNA-1468
Herpes Zoster vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 659
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
timeFrame: Up to Day 64 (7 days after each injection)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 85 (28 days after each injection)
measure: 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)
measure: Number of Participants with Medically Attended AEs
timeFrame: Day 1 to Day 393 (12 months after last study injection)
Secondary outcomes:
measure: Vaccine Seroresponse Rate of Participants
timeFrame: Day 85 and Day 225 (1 and 6 months after the last injection)
measure: 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)
measure: 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)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Velocity Clinical Research - Westlake
state: California
city: Longmont
country: United States
facility: Tekton Research, Inc - Longmont Center
state: Colorado
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research
state: Florida
city: Miami
country: United States
facility: Clinical Trials of Florida, LLC
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC
state: Florida
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Chicago
country: United States
facility: Great Lakes
state: Illinois
city: River Forest
country: United States
facility: DM Clinical Research- River Forest
state: Illinois
city: Sioux City
country: United States
facility: Meridian Clinical Research - Dakota Dunes
state: Iowa
city: Lenexa
country: United States
facility: Johnson County Clin-Trials (JCCT)
state: Kansas
city: New Orleans
country: United States
facility: NOLA Research Works
state: Louisiana
city: Medford
country: United States
facility: Velocity Clinical Research - Medford
state: Oregon
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research
state: Texas
city: Houston
country: United States
facility: LinQ Research, LLC
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: San Juan
country: Puerto Rico
facility: Research Works San Juan
Study officials:
References: