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

Herpes Zoster Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05701800
• Other study ID #: mRNA-1468-P101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 23, 2023
• Est. completion date: July 8, 2024

Study information

• Verified date: June 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 507
• Est. completion date: July 8, 2024
• Est. primary completion date: July 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Zoster

Intervention

Biological:
• mRNA-1468
Sterile liquid dispersion for injection
• Placebo
Sterile liquid for injection
• Shingrix
Sterile suspension for injection

Locations

Country	Name	City	State
Puerto Rico	Research Works San Juan	San Juan
United States	Tekton Research	Austin	Texas
United States	Gadolin Research	Beaumont	Texas
United States	WR-ClinSearch, LLC	Chattanooga	Tennessee
United States	Great Lakes	Chicago	Illinois
United States	Centricity Research	Columbus	Georgia
United States	LinQ Research, LLC	Houston	Texas
United States	Meridien Research	Lakeland	Florida
United States	Johnson County Clin-Trials (JCCT)	Lenexa	Kansas
United States	Tekton Research, Inc - Longmont Center	Longmont	Colorado
United States	Velocity Clinical Research - Westlake	Los Angeles	California
United States	Velocity Clinical Research - Medford	Medford	Oregon
United States	Clinical Trials of Florida, LLC	Miami	Florida
United States	Floridian Clinical Research	Miami Lakes	Florida
United States	NOLA Research Works	New Orleans	Louisiana
United States	DM Clinical Research - Philadelphia	Philadelphia	Pennsylvania
United States	DM Clinical Research- River Forest	River Forest	Illinois
United States	Meridian Clinical Research - Dakota Dunes	Sioux City	Iowa
United States	DM Clinical Research	Tomball	Texas
United States	Florida Pulmonary Research Institute, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions		Up to Day 64 (7 days after each injection)
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 85 (28 days after each injection)
Primary	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		Up to Day 393 (Month 14)
Secondary	Geometric Mean Titer of Anti-glycoprotein E (gE)-specific Binding Antibodies (bAb) as Measured by Enzyme-linked Immunosorbent Assay		Day 85 (1 month after injection)
Secondary	Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Titer		Baseline, Day 85 and Day 225 (1 and 6 months after each injection)
Secondary	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	Day 85 and Day 225 (6 months after each injection)