MRNA-1608（一种单纯疱疹病毒 -2 (HSV-2) 治疗候选疫苗）在 18 至 55 岁复发性 HSV-2 生殖器疱疹健康成人中的研究
2026年4月17日 更新者：ModernaTX, Inc.
MRNA-1608（一种 HSV-2 治疗候选疫苗）在 18 至 55 岁患有复发性 HSV-2 生殖器疱疹的健康成年人中进行的一项 1/2 期、随机、观察者盲法、对照、剂量范围研究
本研究的目的是生成安全性和免疫原性数据，并建立 mRNA-1608 候选疫苗临床效益的概念验证。
研究概览
详细说明
有复发性生殖器疱疹病史的参与者将以 1:1:1:1 的比例随机分配，接受 3 个剂量水平之一的 mRNA-1608 或对照 (BEXSERO)，在第 0 个月和第 2 个月（第1 和第 57 天）。
研究类型
介入性
注册 (实际的)
303
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35218
- Accel Clinical Sites Network - Cahaba Medical Care
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Arizona
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Tucson、Arizona、美国、85704
- Noble Clinical Research
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California
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Beverly Hills、California、美国、90211
- Cedars-Sinai Medical Center/Carbon Health
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San Diego、California、美国、92120
- Acclaim Clinical Research
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Florida
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Lake City、Florida、美国、32055
- Multi-Specialty Research Associates, Inc.
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Miami、Florida、美国、33173
- Suncoast Research Associates, LLC
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Kansas
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Lenexa、Kansas、美国、66219
- Johnson County Clin-Trials (JCCT)
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Newton、Kansas、美国、67114
- Alliance for Multispecialty Research, LLC
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Louisiana
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New Orleans、Louisiana、美国、70125
- Research Works
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Massachusetts
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Boston、Massachusetts、美国、02215
- Fenway Health
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Michigan
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Southfield、Michigan、美国、48076
- DM Clinical Research
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Nebraska
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Grand Island、Nebraska、美国、68803
- Velocity Clinical Research
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Norfolk、Nebraska、美国、68701
- Velocity Clinical Research
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New York
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Rochester、New York、美国、14609
- Rochester Clinical Research
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North Carolina
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Raleigh、North Carolina、美国、27612
- M3 Wake Research, Inc.
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Ohio
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Beachwood、Ohio、美国、44122
- Velocity Clinical Research Cleveland
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Texas
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Cedar Park、Texas、美国、78613
- Velocity Clinical Research, Austin
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Fort Worth、Texas、美国、76107
- Helios CR, Inc Fort Worth
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Houston、Texas、美国、77081
- DM Clinical Research
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San Antonio、Texas、美国、78215
- Sun Research Institute
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Tomball、Texas、美国、77064
- DM Clinical Research
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Virginia
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Newport News、Virginia、美国、23606
- Health Research of Hampton Roads
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Washington
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Seattle、Washington、美国、98104
- University of Washington Virology Research Clinic
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
纳入标准：
- 参与者在筛选访视前至少 1 年被诊断患有生殖器 HSV-2 感染。
- 通过 Western Blot 测定，HSV-2 血清呈阳性。
- 参与者有复发性生殖器疱疹病史，定义为在筛选访视前的 12 个月内至少 3 次且不超过 9 次报告的生殖器疱疹复发，或者如果目前正在接受抑制治疗，则在开始抑制治疗之前。
- 愿意从筛选访视到研究结束期间不接受抑制性抗病毒治疗。
- 愿意在三个 28 天的肛门生殖器拭子期间避免使用间歇性抗病毒治疗。 间歇性治疗可以在三个 28 天的拭子期之外使用。
- 对于有生育能力的女性参与者：妊娠试验阴性、充分避孕且目前未进行母乳喂养。
排除标准：
- 事先使用含有 HSV 抗原的疫苗进行免疫。
- 任何形式的眼部 HSV 感染、HSV 相关的多形红斑或 HSV 相关的神经系统并发症的病史。
- 生殖器 HSV-1 感染史。
- 乙型肝炎、丙型肝炎或人类免疫缺陷病毒 (HIV) 1 型或 2 型（HIV-1、HIV-2）病史。
- 接受任何 mRNA 疫苗或 mRNA 疫苗的任何成分后报告的过敏反应或严重超敏反应史。
- 之前接受过 BEXSERO 或其他疫苗来预防 B 群脑膜炎球菌病（也称为 B 型脑膜炎）。
- BEXSERO 疫苗的任何成分可能会加剧过敏性疾病或反应史。
- 在首次研究注射（第 1 天）之前 ≤ 28 天已接受或计划接受任何许可或授权的疫苗，包括 COVID-19 疫苗，或计划在研究注射之前或之后 28 天内接受许可或授权的疫苗获得许可的流感疫苗除外，该疫苗可能在任何研究注射之前或之后 14 天以上接种。
注：其他纳入和排除标准可能适用。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：mRNA-1608 剂量 A
参与者将接受 2 次剂量水平 A 的 mRNA-1608 肌内 (IM) 注射，每次剂量在 0 个月和 2 个月（第 1 天和第 57 天）注射。
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无菌注射液
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实验性的：mRNA-1608 剂量 B
参与者将接受 2 次 B 剂量 mRNA-1608 的肌内注射，每次剂量在 0 个月和 2 个月（第 1 天和第 57 天）注射。
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无菌注射液
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实验性的：mRNA-1608 剂量 C
参与者将接受 2 次剂量水平 C 的 mRNA-1608 肌内注射，每次剂量在 0 个月和 2 个月（第 1 天和第 57 天）注射。
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无菌注射液
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其他：贝克斯塞罗
参与者将接受 2 次肌内注射 BEXSERO，每次剂量在 0 个月和 2 个月（第 1 天和第 57 天）注射。
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一种用于主动免疫以预防由 B 群脑膜炎奈瑟菌引起的侵袭性疾病的疫苗。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of Participants With Solicited Local and Systemic ARs
大体时间：Up to Day 64 (Within 7 days after study vaccination)
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Solicited ARs were collected in an electronic diary (eDiary).
Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills.
Note, not all solicited ARs were considered adverse events (AEs).
Investigator reviewed whether the solicited AR was also to be recorded as an AE.
A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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Up to Day 64 (Within 7 days after study vaccination)
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Number of Participants With Unsolicited Adverse Events (AEs)
大体时间：Up to Day 85 (Up to 28 days after study vaccination)
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An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE.
A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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Up to Day 85 (Up to 28 days after study vaccination)
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Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation
大体时间：Day 1 through Day 393
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An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event.
An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor were required.
A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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Day 1 through Day 393
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Number of Participants With Medically Attended AEs (MAAEs)
大体时间：Day 1 through Day 393
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A MAAE is an AE that led to an unscheduled visit to a healthcare practitioner.
A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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Day 1 through Day 393
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Number of Genital Herpes Recurrence Episode Per Participant, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection
大体时间：Day 71 up to Day 225
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An episode of recurrence was defined as one or more consecutive "yes" to the "Do you have genital herpes lesion?" question either from Genital Herpes Signs and Symptoms (GHSS) or daily recurrence eDiary within a 14-day period from the first "yes" response regardless of "no" or missing entries in between.
The start date of an episode was the first date of "yes" response, and the end date of an episode was the last date of "yes" within the episode.
The recurrence analysis period up to 6 months included the time from 14 days after the second injection until the last GHSS or daily recurrence eDiary collected up to the 1) the Day 225 visit date or 2) if Day 225 visit date is not available, the earliest of study Day 225 or study discontinuation date.
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Day 71 up to Day 225
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Number of Genital Herpes Recurrence Episode Per Participant, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection
大体时间：Day 71 up to Day 393
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An episode of recurrence was defined as one or more consecutive "yes" to the "Do you have genital herpes lesion?" question either from GHSS or daily recurrence eDiary within a 14-day period from the first "yes" response regardless of "no" or missing entries in between.
The start date of an episode was the first date of "yes" response, and the end date of an episode was the last date of "yes" within the episode.
The recurrence analysis period up to 12 months included the time from 14 days after the second injection until the last GHSS or daily recurrence eDiary collected up to the 1) the Day 393 visit date or 2) if Day 393 visit date is not available, the earliest of study Day 393 or study discontinuation date.
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Day 71 up to Day 393
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Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in Genital Herpes Lesion Rate (Percentage of Days With Lesions Present)
大体时间：Baseline (Day -27 to Day 1), Day 113
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Genital herpes lesion rate was defined for each 28-day swabbing period as the number of days with lesion present according to the eDiary divided by the number of days during the 28-day swabbing period.
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Baseline (Day -27 to Day 1), Day 113
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Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in Genital Herpes Lesion Rate (Percentage of Days With Lesions Present)
大体时间：Baseline (Day -27 to Day 1), Day 225
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Genital herpes lesion rate was defined for each 28-day swabbing period as the number of days with lesion present according to the eDiary divided by the number of days during the 28-day swabbing period.
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Baseline (Day -27 to Day 1), Day 225
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Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Percentage of HSV-2 Deoxyribonucleic Acid [DNA] Positive Anogenital Swabs)
大体时间：Baseline (Day -27 to Day 1), Day 113
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Genital shedding rate was defined for each 28-day swabbing period as the number of anogenital swabs with HSV-2 DNA positive results (that is, positive results per polymerase chain reaction [PCR]) divided by the number of swabs during the swabbing period.
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Baseline (Day -27 to Day 1), Day 113
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Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Percentage of HSV-2 DNA Positive Anogenital Swabs)
大体时间：Baseline (Day -27 to Day 1), Day 225
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Genital shedding rate was defined for each 28-day swabbing period as the number of anogenital swabs with HSV-2 DNA positive results (that is, positive results per PCR) divided by the number of swabs during the swabbing period.
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Baseline (Day -27 to Day 1), Day 225
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Geometric Mean (GM) Value of mRNA-1608 Antigen-Specific Binding Antibodies (bAbs)
大体时间：Days 85 and 197
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Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 * LLOQ.
Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available.
LLOQ was 1220 units (U)/milliliter (mL) and ULOQ was 6890000 U/mL for HSV2 gB.
LLOQ was 1230 U/mL and ULOQ was 21300000 U/mL for HSV2 gC.
LLOQ was 2220 U/mL and ULOQ was 23900000 U/mL for HSV2 gD.
95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values for GM, then back transformed to the original scale for presentation.
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Days 85 and 197
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Geometric Mean Fold Rise (GMFR) of mRNA-1608 Antigen-Specific bAbs
大体时间：Days 85 and 197
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Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ.
Values greater than the ULOQ were replaced by the ULOQ if actual values were not available.
LLOQ was 1220 U/mL and ULOQ was 6890000 U/mL for HSV2 gB.
LLOQ was 1230 U/mL and ULOQ was 21300000 U/mL for HSV2 gC.
LLOQ was 2220 U/mL and ULOQ was 23900000 U/mL for HSV2 gD.
95% CI was calculated based on the t-distribution of the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
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Days 85 and 197
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Percentage of Participants With Vaccine Seroresponse
大体时间：Day 85
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Seroresponse was defined as a change from baseline below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold rise if baseline was equal to or above the LLOQ.
LLOQ was 1220 U/mL and ULOQ was 6890000 U/mL for HSV2 gB.
LLOQ was 1230 U/mL and ULOQ was 21300000 U/mL for HSV2 gC.
LLOQ was 2220 U/mL and ULOQ was 23900000 U/mL for HSV2 gD.
95% CI was calculated using the Clopper-Pearson method.
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Day 85
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年9月6日
初级完成 (实际的)
2025年4月25日
研究完成 (实际的)
2025年4月25日
研究注册日期
首次提交
2023年9月5日
首先提交符合 QC 标准的
2023年9月5日
首次发布 (实际的)
2023年9月13日
研究记录更新
最后更新发布 (实际的)
2026年5月8日
上次提交的符合 QC 标准的更新
2026年4月17日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.