18~70세 참가자의 라임병에 대한 mRNA-1975 및 mRNA-1982의 안전성 및 면역원성을 평가하기 위한 연구
2026년 7월 6일 업데이트: ModernaTX, Inc.
라임병과 병행하여 7가 mRNA-1975(SR1-7) 및 1가 mRNA-1982(SR1)의 안전성 및 면역원성을 평가하기 위한 1/2상, 무작위, 관찰자 맹검, 위약 대조, 용량 범위 연구 18세에서 70세 사이의 건강한 참가자
이 연구의 목적은 건강한 성인 참가자의 라임병에 대한 7가 mRNA-1975 및 1가 mRNA-1982의 안전성과 면역원성을 평가하는 것입니다.
연구 개요
연구 유형
중재적
등록 (실제)
807
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Connecticut
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Milford, Connecticut, 미국, 06460
- Clinical Research Consulting, LLC
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Stamford, Connecticut, 미국, 06905
- Stamford Therapeutics Consortium
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Waterbury, Connecticut, 미국, 06708
- Chase Medical Research, LLC
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Florida
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Jacksonville, Florida, 미국, 32216
- Encore Research Group-Jacksonville Center for Clinical Research
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Lake Mary, Florida, 미국, 32746
- University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
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Georgia
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Stockbridge, Georgia, 미국, 30281
- Clinical Research Atlanta, headlands LLC
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Kansas
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Lenexa, Kansas, 미국, 66219
- Johnson County Clin-Trials, Inc. (JCCT)
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Maryland
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Columbia, Maryland, 미국, 21045
- Centennial Medical Group
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Rockville, Maryland, 미국, 20850
- Advanced Primary and Geriatric Care
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Massachusetts
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Brookline, Massachusetts, 미국, 02445
- DM Clinical Research - Brookline
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Minnesota
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Minneapolis, Minnesota, 미국, 55402
- Clinical Research Institute, Inc.
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Nebraska
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Omaha, Nebraska, 미국, 68134
- Meridian Clinical Research - Omaha
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New Hampshire
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Newington, New Hampshire, 미국, 03801
- ActivMed Research LLC
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New York
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Rochester, New York, 미국, 14609
- Rochester Clinical Research, Inc.
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73112
- Lynn Health Science Institute
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Pennsylvania
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Hatboro, Pennsylvania, 미국, 19040
- Hatboro Medical Associates/CCT Research
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Rhode Island
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Providence, Rhode Island, 미국, 02886
- Velocity Clinical Research Providence
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Texas
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Fort Worth, Texas, 미국, 76135
- Benchmark Research
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Tomball, Texas, 미국, 77375
- DM Clinical Research
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Virginia
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Charlottesville, Virginia, 미국, 22911
- Charlottesville Medical Research Center, LLC
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
- 스크리닝 방문 시 18 내지 39 킬로그램/제곱미터(포함)의 체질량 지수.
- 가임 가능성이 있는 참여자는 연구에 등록할 수 있습니다.
- 가임 여성 참가자의 경우: 임신 테스트 음성, 적절한 피임 또는 연구 개입 기간 동안 임신을 초래할 수 있는 모든 활동을 삼가했으며 마지막 연구 주사 후 3개월 동안 적절한 피임 또는 금욕을 지속하기로 동의했습니다.
제외 기준:
- 의사가 의심하거나 진단한 라임병 또는 활성 증상이 있는 라임병 감염과 관련된 만성 질환이 있습니다.
- 지난 3개월 이내에 라임병 치료를 받은 경우.
- 이전에 라임병 예방접종을 받았거나 과거에 라임병 백신 연구에 참여한 적이 있습니다.
- 연구 주사 방문 전 4주 이내에 진드기에 물렸습니다.
- 지역에서 요청한 AR 평가에 영향을 줄 수 있는 피부과적 상태(예: 문신, 삼각근 부위의 피부에 영향을 미치는 건선 패치).
- 스크리닝 방문 전 180일 이내에 총 >14일 동안 전신 면역억제제를 투여받았거나(코르티코스테로이드의 경우, 프레드니손 또는 등가물의 10mg/일 이상) 연구에 참여하는 동안 언제든지 전신 면역억제 치료가 필요할 것으로 예상됩니다.
- 과거 병력의 시기에 관계없이 심근염, 심낭염 또는 심낭염의 병력.
- 아나필락시스, 두드러기 또는 연구 주사에 포함된 동일한 성분 중 하나 이상을 포함하는 백신 또는 중재를 받은 후 의학적 개입이 필요한 기타 중대한 이상 반응의 병력.
- 스크리닝 방문 전 90일 이내에 전신 면역글로불린, 면역 반응에 영향을 미치는 장기간 작용하는 생물학적 요법(예: 인플릭시맙) 또는 혈액 제품을 받았거나 연구 중에 받을 계획입니다.
참고: 기타 포함 및 제외 기준이 적용될 수 있습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: mRNA-1975: 용량 1
참가자는 1일, 57일 및 169일에 용량 수준 1에서 mRNA-1975 백신을 3회 근육내(IM) 주사받습니다.
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분산 전달 IM
다른 이름들:
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실험적: mRNA-1975: 용량 2
참가자는 1일, 57일 및 169일에 용량 수준 2에서 mRNA-1975 백신을 3회 IM 주사합니다.
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분산 전달 IM
다른 이름들:
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실험적: mRNA-1975: 용량 3
참가자는 1일, 57일 및 169일에 복용량 수준 3에서 mRNA-1975 백신을 3회 IM 주사합니다.
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분산 전달 IM
다른 이름들:
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실험적: mRNA-1975: 용량 4
참가자는 1일, 57일 및 169일에 용량 수준 4로 mRNA-1975 백신을 3회 IM 주사합니다.
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분산 전달 IM
다른 이름들:
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실험적: mRNA-1982: 용량 1
참가자는 1일, 57일 및 169일에 용량 수준 1에서 mRNA-1982 백신을 3회 IM 주사합니다.
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분산 전달 IM
다른 이름들:
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실험적: mRNA-1982: 용량 2
참가자는 1일, 57일 및 169일에 용량 수준 2에서 mRNA-1982 백신을 3회 IM 주사합니다.
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분산 전달 IM
다른 이름들:
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실험적: mRNA-1982: 용량 3
참가자는 1일, 57일 및 169일에 용량 수준 3에서 mRNA-1982 백신을 3회 IM 주사합니다.
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분산 전달 IM
다른 이름들:
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위약 비교기: 위약
참가자는 1일, 57일 및 169일에 백신과 일치하는 위약을 3회 IM 주사합니다.
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솔루션 제공 IM
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: Days 1, 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 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
기간: 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
기간: Days 1, 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 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.
|
Days 1, 29, 85 and 197
|
|
Geometric Mean Fold Rise (GMFR) of Anti-OspA Binding IgG Antibody Concentration for SR-1 Antigen
기간: 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 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.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-2 Antigen
기간: 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.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-3 Antigen
기간: 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.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-4 Antigen
기간: 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
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Deaths Related to Study Drug
기간: 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
|
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연구 기록 날짜
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연구 주요 날짜
연구 시작 (실제)
2023년 7월 26일
기본 완료 (실제)
2025년 5월 30일
연구 완료 (실제)
2025년 5월 30일
연구 등록 날짜
최초 제출
2023년 7월 26일
QC 기준을 충족하는 최초 제출
2023년 7월 26일
처음 게시됨 (실제)
2023년 8월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 6일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- mRNA-1975/1982-P101
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
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