一项评估 mRNA-1975 和 mRNA-1982 对 18 至 70 岁参与者对抗莱姆病的安全性和免疫原性的研究
2026年7月6日 更新者：ModernaTX, Inc.
一项 1/2 期、随机、观察者盲法、安慰剂对照、剂量范围研究，旨在评估七价 mRNA-1975 (SR1-7) 和单价 mRNA-1982 (SR1) 平行对抗莱姆病的安全性和免疫原性18 岁至 70 岁的健康参与者
本研究的目的是平行评估七价 mRNA-1975 和单价 mRNA-1982 在健康成年参与者中对抗莱姆病的安全性和免疫原性。
研究概览
研究类型
介入性
注册 (实际的)
807
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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Connecticut
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Milford、Connecticut、美国、06460
- Clinical Research Consulting, LLC
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Stamford、Connecticut、美国、06905
- Stamford Therapeutics Consortium
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Waterbury、Connecticut、美国、06708
- Chase Medical Research, LLC
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Florida
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Jacksonville、Florida、美国、32216
- Encore Research Group-Jacksonville Center for Clinical Research
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Lake Mary、Florida、美国、32746
- University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
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Georgia
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Stockbridge、Georgia、美国、30281
- Clinical Research Atlanta, headlands LLC
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Kansas
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Lenexa、Kansas、美国、66219
- Johnson County Clin-Trials, Inc. (JCCT)
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Maryland
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Columbia、Maryland、美国、21045
- Centennial Medical Group
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Rockville、Maryland、美国、20850
- Advanced Primary and Geriatric Care
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Massachusetts
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Brookline、Massachusetts、美国、02445
- DM Clinical Research - Brookline
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Minnesota
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Minneapolis、Minnesota、美国、55402
- Clinical Research Institute, Inc.
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Nebraska
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Omaha、Nebraska、美国、68134
- Meridian Clinical Research - Omaha
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New Hampshire
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Newington、New Hampshire、美国、03801
- ActivMed Research LLC
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New York
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Rochester、New York、美国、14609
- Rochester Clinical Research, Inc.
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Oklahoma
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Oklahoma City、Oklahoma、美国、73112
- Lynn Health Science Institute
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Pennsylvania
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Hatboro、Pennsylvania、美国、19040
- Hatboro Medical Associates/CCT Research
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Rhode Island
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Providence、Rhode Island、美国、02886
- Velocity Clinical Research Providence
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Texas
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Fort Worth、Texas、美国、76135
- Benchmark Research
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Tomball、Texas、美国、77375
- DM Clinical Research
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Virginia
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Charlottesville、Virginia、美国、22911
- Charlottesville Medical Research Center, LLC
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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
- 年长者
接受健康志愿者
是的
描述
纳入标准：
- 筛查访视时体重指数为 18 至 39 公斤/平方米（含）。
- 无生育能力的参与者可以参加该研究。
- 对于有生育能力的女性参与者：妊娠测试呈阴性，充分避孕或在研究干预期间放弃所有可能导致怀孕的活动，并同意在最后一次研究注射后 3 个月内继续充分避孕或禁欲。
排除标准：
- 患有与莱姆病相关的慢性疾病或经医生怀疑或诊断的活动性症状性莱姆病感染。
- 过去 3 个月内接受过莱姆病治疗。
- 之前接种过莱姆病疫苗或过去参加过任何莱姆病疫苗研究。
- 在研究注射访视前 4 周内曾被蜱虫叮咬。
- 可能影响局部 AR 评估的皮肤病（例如纹身；影响三角肌区域皮肤的牛皮癣斑块）。
- 在筛选访视前 180 天内接受全身免疫抑制剂总计 >14 天（对于皮质类固醇，≥10 毫克/天的泼尼松或等效药物）或预计在参与研究期间的任何时间需要全身免疫抑制治疗。
- 心肌炎、心包炎或心肌心包炎病史，无论既往病史发生的时间。
- 在接受包含一种或多种与研究注射剂中相同成分的疫苗或干预措施后，有过敏反应、荨麻疹或其他需要医疗干预的重大不良反应史。
- 在筛选访视前 90 天内或计划在研究期间接受全身免疫球蛋白、影响免疫反应的长效生物疗法（例如英夫利昔单抗）或血液制品。
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：mRNA-1975：第 1 剂
参与者将在第 1 天、第 57 天和第 169 天接受 3 次肌肉内 (IM) 注射 mRNA-1975 疫苗，剂量为 1。
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分散传递 IM
其他名称：
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实验性的：mRNA-1975：第 2 剂
参与者将在第 1、57 和 169 天接受 3 次 2 剂量 mRNA-1975 疫苗的肌内注射。
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分散传递 IM
其他名称：
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实验性的：mRNA-1975：第 3 剂
参与者将在第 1、57 和 169 天接受 3 次 mRNA-1975 疫苗的肌内注射，剂量为 3。
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分散传递 IM
其他名称：
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实验性的：mRNA-1975：第 4 剂
参与者将在第 1、57 和 169 天接受 3 次 mRNA-1975 疫苗的肌内注射，剂量为 4。
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分散传递 IM
其他名称：
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实验性的：mRNA-1982：第 1 剂
参与者将在第 1 天、第 57 天和第 169 天接受 3 次 mRNA-1982 疫苗的肌肉注射，剂量为 1。
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分散传递 IM
其他名称：
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实验性的：mRNA-1982：第 2 剂
参与者将在第 1 天、第 57 天和第 169 天接受 3 次 2 剂量 mRNA-1982 疫苗的肌内注射。
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分散传递 IM
其他名称：
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实验性的：mRNA-1982：第 3 剂
参与者将在第 1 天、第 57 天和第 169 天接受 3 次 mRNA-1982 疫苗的肌内注射，剂量为 3。
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分散传递 IM
其他名称：
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安慰剂比较：安慰剂
参与者将在第 1 天、第 57 天和第 169 天接受 3 次肌内注射疫苗匹配安慰剂。
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交付的 IM 解决方案
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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 Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
大体时间：Up to 7 days after Day 1 injection
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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 7 days after Day 1 injection
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Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 57 Injection
大体时间：Up to 7 days after Day 57 injection
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Solicited ARs were collected in an 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 AEs.
Investigator reviewed whether the solicited AR was also to be recorded as an AE.
A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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Up to 7 days after Day 57 injection
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Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 169 Injection
大体时间：Up to 7 days after Day 169 injection
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Solicited ARs were collected in an 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 AEs.
Investigator reviewed whether the solicited AR was also to be recorded as an AE.
A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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Up to 7 days after Day 169 injection
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Number of Participants With Unsolicited AEs
大体时间：Up to 28 days post any injection
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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 28 days post any injection
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Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Study Discontinuation
大体时间：Day 1 up to Month 18
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A MAAE is an AE that led to an unscheduled visit to a healthcare practitioner.
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 up to Month 18
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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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Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein (Anti-OspA) Binding Immunoglobulin (IgG) Antibodies for Serotype (SR-1) Antigen Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
大体时间：Days 1, 29, 85 and 197
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Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ.
Values reported greater than upper limit of quantification (ULOQ) were replaced by the ULOQ.
LLOQ was 41.4 nanograms (ng)/milliliter (mL) and ULOQ was 428000 ng/mL for manual assay; LLOQ was 47.6 ng/mL and 583000 ng/mL for automated assay for SR-1 IgG antibody.
95% confidence interval (CI) for GM value was calculated based on the t-distribution of the log-transformed values , then back transformed to the original scale for presentation.
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Days 1, 29, 85 and 197
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GMC of Anti-OspA Binding IgG Antibodies for SR-2 Antigen Measured by ELISA
大体时间：Days 1, 29, 85, and 197
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Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 30 ng/mL and ULOQ was 214000 ng/mL for manual assay; LLOQ was 66.6 ng/mL and 215000 ng/mL for automated assay for SR-2 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
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Days 1, 29, 85, and 197
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GMC of Anti-OspA Binding IgG Antibodies for SR-3 Antigen Measured by ELISA
大体时间：Days 1, 29, 85 and 197
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Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 14.5 ng/mL and ULOQ was 299000 ng/mL for manual assay; LLOQ was 62.5 ng/mL and 296000 ng/mL for automated assay for SR-3 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
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Days 1, 29, 85 and 197
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GMC of Anti-OspA Binding IgG Antibodies for SR-4 Antigen Measured by ELISA
大体时间：Days 1, 29, 85 and 197
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Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 32.6 ng/mL and ULOQ was 292000 ng/mL for manual assay; LLOQ was 59.7 ng/mL and 264000 ng/mL for automated assay for SR-4 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
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Days 1, 29, 85 and 197
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GMC of Anti-OspA Binding IgG Antibodies for SR-5 Antigen Measured by ELISA
大体时间：Days 1, 29, 85 and 197
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Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 45.5 ng/mL and ULOQ was 298000 ng/mL for manual assay; LLOQ was 84.2 ng/mL and 319000 ng/mL for automated assay for SR-5 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
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Days 1, 29, 85 and 197
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GMC of Anti-OspA Binding IgG Antibodies for SR-6 Antigen Measured by ELISA
大体时间：Days 1, 29, 85 and 197
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Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 18.1 ng/mL and ULOQ was 203000 ng/mL for manual assay; LLOQ was 68.7 ng/mL and 248000 ng/mL for automated assay for SR-6 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
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Days 1, 29, 85 and 197
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GMC of Anti-OspA Binding IgG Antibodies for SR-7 Antigen Measured by ELISA
大体时间：Days 1, 29, 85 and 197
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Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 13 ng/mL and ULOQ was 197000 ng/mL for manual assay; LLOQ was 78.9 ng/mL and 174000 ng/mL for automated assay for SR-7 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
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Days 1, 29, 85 and 197
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Geometric Mean Fold Rise (GMFR) of Anti-OspA Binding IgG Antibody Concentration for SR-1 Antigen
大体时间：Days 29, 85 and 197
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Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 41.4 ng/mL and ULOQ was 428000 ng/mL for manual assay; LLOQ was 47.6 ng/mL and 583000 ng/mL for automated assay for SR-1 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
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Days 29, 85 and 197
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GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-2 Antigen
大体时间：Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 30 ng/mL and ULOQ was 214000 ng/mL for manual assay; LLOQ was 66.6 ng/mL and 215000 ng/mL for automated assay for SR-2 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
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Days 29, 85 and 197
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GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-3 Antigen
大体时间：Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 14.5 ng/mL and ULOQ was 299000 ng/mL for manual assay; LLOQ was 62.5 ng/mL and 296000 ng/mL for automated assay for SR-3 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
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Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-4 Antigen
大体时间：Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 32.6 ng/mL and ULOQ was 292000 ng/mL for manual assay; LLOQ was 59.7 ng/mL and 264000 ng/mL for automated assay for SR-4 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-5 Antigen
大体时间：Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 45.5 ng/mL and ULOQ was 298000 ng/mL for manual assay; LLOQ was 84.2 ng/mL and 319000 ng/mL for automated assay for SR-5 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-6 Antigen
大体时间：Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 18.1 ng/mL and ULOQ was 203000 ng/mL for manual assay; LLOQ was 68.7 ng/mL and 248000 ng/mL for automated assay for SR-6 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-7 Antigen
大体时间：Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 13 ng/mL and ULOQ was 197000 ng/mL for manual assay; LLOQ was 78.9 ng/mL and 174000 ng/mL for automated assay for SR-7 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 29, 85 and 197
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Deaths Related to Study Drug
大体时间：Day 1 up to Month 18
|
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug.
The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death).
The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug.
The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug.
Related: There was a reasonable possibility of a relationship to the study drug.
There was evidence of exposure to the study drug.
The temporal sequence of the death relative to the administration of the study drug was reasonable.
The death was more likely explained by the study drug than by another cause.
|
Day 1 up to Month 18
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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7月26日
初级完成 (实际的)
2025年5月30日
研究完成 (实际的)
2025年5月30日
研究注册日期
首次提交
2023年7月26日
首先提交符合 QC 标准的
2023年7月26日
首次发布 (实际的)
2023年8月3日
研究记录更新
最后更新发布 (实际的)
2026年7月30日
上次提交的符合 QC 标准的更新
2026年7月6日
最后验证
2026年7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.