A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults =50 Years of Age
- Conditions
- Herpes Zoster
- Registration Number
- NCT05701800
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Part 1: Is an adult 50 years of age or older at the time of consent. Part 2: Is an<br> adult 50-69 years of age at the time of consent.<br><br> - Has a body mass index of 18 to <40 kilograms/meter squared at the Screening Visit.<br><br> - Females of childbearing potential: have a negative pregnancy test at the Screening<br> Visit and on the day of the first vaccination (Day 1); have practiced adequate<br> contraception or has abstained from all activities that could result in pregnancy<br> for at least 28 days prior to Day 1; have agreed to continue adequate contraception<br> through 3 months following vaccine administration; are not currently breastfeeding.<br><br>Exclusion Criteria:<br><br> - Has a history of HZ within the past 10 years.<br><br> - Has been previously vaccinated against varicella or HZ.<br><br> - Is acutely ill or febrile<br><br> - Body temperature =38.0°Celsius/100.4°Fahrenheit 72 hours prior to or at the<br> Screening Visit or on Day 1. Participants meeting this criterion may be rescheduled<br> within the allowed window.<br><br> - Has a current or previous diagnosis of congenital or acquired immunodeficiency,<br> immunocompromizing/immunosuppressive condition, asplenia, or recurrent severe<br> infections. Certain immune-mediated conditions that are well controlled and stable<br> (for example, Hashimoto thyroiditis) as well as those that do not require systemic<br> immunosuppressive therapy (for example, asthma, psoriasis, or vitiligo) may be<br> permitted at the discretion of the Investigator.<br><br> - Has a dermatologic condition that could affect local solicited adverse reaction<br> assessments (for example, tattoos, psoriasis patches affecting skin over the deltoid<br> areas).<br><br> - Has any medical, psychiatric, or occupational condition, including reported history<br> of substance abuse, that, in the opinion of the Investigator, might pose additional<br> risk due to participation in the study or could interfere with the interpretation of<br> study results.<br><br> - Has a history of myocarditis, pericarditis, or myopericarditis.<br><br> - Has a reported history of anaphylaxis or severe hypersensitivity reaction after<br> receipt of any mRNA vaccine(s) or any components of the mRNA vaccines.<br><br> - Has received systemic immunosuppressants for >14 days in total within 180 days prior<br> to Screening Visit (for corticosteroids =10 milligrams/day of prednisone or<br> equivalent) or is anticipating the need for systemic immunosuppressive treatment at<br> any time during participation in the study. Inhaled, nasal, intra-articular and<br> topical steroids are allowed.<br><br> - Has received systemic immunoglobulins, long-acting biological therapies that affect<br> immune responses (for example, Infliximab) or blood products within 90 days prior to<br> the Screening Visit or plans to receive them during the study.<br><br>Other protocol-defined inclusion/exclusion criteria apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions;Number of Participants with Unsolicited Adverse Events (AEs);Number of Participants with Serious AEs, AEs Leading to Discontinuation of Study Vaccine or Withdrawal From the Study, and AEs of Special Interest;Number of Participants with Medically Attended AEs
- Secondary Outcome Measures
Name Time Method Vaccine Seroresponse Rate of Participants;Geometric Mean Concentration of Anti-gE-specific bAb as Measured by Enzyme-linked Immunosorbent Assay;Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Concentration