Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
2상
완료
NCT04232280
| 대상 질환 | Cytomegalovirus Infection |
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| 임상 단계 | 2상 |
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| 스폰서 | ModernaTX, Inc. |
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| 상태 | 완료 |
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| 참여자 수 | 315 명 |
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| 중재(약물) | mRNA-1647 |
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| 시작일 | 2020년 1월 9일 |
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| 완료일 | 2023년 1월 4일 |
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| 결과 공개일 | 2026년 5월 5일 |
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요약
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 |
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| Seronegative mRNA-1647 (100 ug) | 59 Participants |
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| Seronegative mRNA-1647 (150 ug) | 40 Participants |
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| Seronegative Placebo | 12 Participants |
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| Seropositive mRNA-1647 (50 ug) | 15 Participants |
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| Seropositive mRNA-1647 (100 ug) | 33 Participants |
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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 |
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| Seronegative mRNA-1647 (100 ug) | 31 Participants |
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| Seronegative mRNA-1647 (150 ug) | 18 Participants |
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| Seronegative Placebo | 21 Participants |
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| Seropositive mRNA-1647 (50 ug) | 10 Participants |
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| Seropositive mRNA-1647 (100 ug) | 16 Participants |
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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 |
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| Seronegative mRNA-1647 (100 ug) | 24 Participants |
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| Seronegative mRNA-1647 (150 ug) | 14 Participants |
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| Seronegative Placebo | 19 Participants |
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| Seropositive mRNA-1647 (50 ug) | 5 Participants |
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| Seropositive mRNA-1647 (100 ug) | 11 Participants |
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BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
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