Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
2期
已完成
NCT04232280
| 适应症 | Cytomegalovirus Infection |
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| 分期 | 2期 |
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| 申办方 | ModernaTX, Inc. |
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| 状态 | 已完成 |
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| 受试者人数 | 315 人 |
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| 干预（药物） | mRNA-1647 |
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| 开始日期 | 2020年1月9日 |
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| 完成日期 | 2023年1月4日 |
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| 结果公布日 | 2026年5月5日 |
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摘要
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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查看 ClinicalTrials.gov 原文
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。