Trials / Active Not Recruiting
Active Not RecruitingNCT05831111
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Participants
A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, 2-Part, Dose-Ranging Study of an EBV Candidate Vaccine, mRNA-1195, in Healthy Participants 18 Through 55 Years of Age
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 482 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.
Detailed description
There will be 2 sequential parts to the study: * Participants 18 through 55 years of age will be enrolled in Part A of the study first, which will only enroll those participants who are EBV-seropositive at Screening. * Part B will enroll participants 18 through 30 years of age who are either EBV-seronegative or EBV-seropositive at Screening.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | mRNA-1195.1 | Sterile liquid for injection |
| BIOLOGICAL | mRNA-1195.2 | Sterile liquid for injection |
| BIOLOGICAL | mRNA-1189 | Sterile liquid for injection |
| BIOLOGICAL | Placebo | 0.9% sodium chloride (normal saline) injection |
| BIOLOGICAL | mRNA-1195 | Sterile liquid for injection |
Timeline
- Start date
- 2023-04-05
- Primary completion
- 2026-10-07
- Completion
- 2026-10-07
- First posted
- 2023-04-26
- Last updated
- 2025-09-30
Locations
34 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05831111. Inclusion in this directory is not an endorsement.