Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
Phase 2
Completed
NCT04232280
| Condition | Cytomegalovirus Infection |
|---|
| Phase | Phase 2 |
|---|
| Sponsor | ModernaTX, Inc. |
|---|
| Status | Completed |
|---|
| Enrollment | 315 participants |
|---|
| Interventions | mRNA-1647 |
|---|
| Start date | Jan 9, 2020 |
|---|
| Completion date | Jan 4, 2023 |
|---|
| Results posted | May 5, 2026 |
|---|
Summary
This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Up to Day 175 (7 days following last dose administration) · Participants
| Seronegative mRNA-1647 (50 ug) | 33 Participants |
|---|
| Seronegative mRNA-1647 (100 ug) | 59 Participants |
|---|
| Seronegative mRNA-1647 (150 ug) | 40 Participants |
|---|
| Seronegative Placebo | 12 Participants |
|---|
| Seropositive mRNA-1647 (50 ug) | 15 Participants |
|---|
| Seropositive mRNA-1647 (100 ug) | 33 Participants |
|---|
Number of Participants With Unsolicited Adverse Events (AEs)
Up to Day 196 (28 days following last dose administration) · Participants
| Seronegative mRNA-1647 (50 ug) | 16 Participants |
|---|
| Seronegative mRNA-1647 (100 ug) | 31 Participants |
|---|
| Seronegative mRNA-1647 (150 ug) | 18 Participants |
|---|
| Seronegative Placebo | 21 Participants |
|---|
| Seropositive mRNA-1647 (50 ug) | 10 Participants |
|---|
| Seropositive mRNA-1647 (100 ug) | 16 Participants |
|---|
Number of Participants With Medically Attended Adverse Events (MAAEs)
Up to Day 336 (6 months following last dose administration) · Participants
| Seronegative mRNA-1647 (50 ug) | 13 Participants |
|---|
| Seronegative mRNA-1647 (100 ug) | 24 Participants |
|---|
| Seronegative mRNA-1647 (150 ug) | 14 Participants |
|---|
| Seronegative Placebo | 19 Participants |
|---|
| Seropositive mRNA-1647 (50 ug) | 5 Participants |
|---|
| Seropositive mRNA-1647 (100 ug) | 11 Participants |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.