A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes
1/2期
已完成
NCT06033261
| 适应症 | Genital Herpes |
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| 分期 | 1/2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 | 303 人 |
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| 干预（药物） | mRNA-1608, BEXSERO |
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| 开始日期 | 2023年9月6日 |
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| 完成日期 | 2025年4月25日 |
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| 结果公布日 | 2026年5月8日 |
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摘要
The purpose of this study is to generate safety and immunogenicity data and establish a proof-of-concept of clinical benefit of the mRNA-1608 vaccine candidate.
Number of Participants With Solicited Local and Systemic ARs
Up to Day 64 (Within 7 days after study vaccination) · Participants
| BEXSERO | 74 Participants |
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| mRNA-1608 Dose Level 1 | 75 Participants |
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| mRNA-1608 Dose Level 2 | 75 Participants |
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| mRNA-1608 Dose Level 3 | 74 Participants |
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Number of Participants With Unsolicited Adverse Events (AEs)
Up to Day 85 (Up to 28 days after study vaccination) · Participants
| BEXSERO | 22 Participants |
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| mRNA-1608 Dose Level 1 | 18 Participants |
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| mRNA-1608 Dose Level 2 | 18 Participants |
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| mRNA-1608 Dose Level 3 | 21 Participants |
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Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation
Day 1 through Day 393 · Participants
| BEXSERO | 0 Participants |
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| mRNA-1608 Dose Level 1 | 2 Participants |
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| mRNA-1608 Dose Level 2 | 2 Participants |
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| mRNA-1608 Dose Level 3 | 2 Participants |
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| BEXSERO | 0 Participants |
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| mRNA-1608 Dose Level 1 | 0 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。