18歳から70歳までの参加者を対象としたライム病に対するmRNA-1975およびmRNA-1982の安全性と免疫原性を評価する研究
2026年7月6日 更新者：ModernaTX, Inc.
ライム病に対する七価 mRNA-1975 (SR1-7) および一価 mRNA-1982 (SR1) の安全性と免疫原性を並行して評価するための第 1/2 相、無作為化、観察者盲検、プラセボ対照、用量範囲研究18歳から70歳までの健康な参加者
この研究の目的は、健康な成人参加者におけるライム病に対する七価 mRNA-1975 と一価 mRNA-1982 の安全性と免疫原性を並行して評価することです。
調査の概要
研究の種類
介入
入学 (実際)
807
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Connecticut
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Milford、Connecticut、アメリカ、06460
- Clinical Research Consulting, LLC
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Stamford、Connecticut、アメリカ、06905
- Stamford Therapeutics Consortium
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Waterbury、Connecticut、アメリカ、06708
- Chase Medical Research, LLC
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Florida
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Jacksonville、Florida、アメリカ、32216
- Encore Research Group-Jacksonville Center for Clinical Research
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Lake Mary、Florida、アメリカ、32746
- University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
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Georgia
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Stockbridge、Georgia、アメリカ、30281
- Clinical Research Atlanta, headlands LLC
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Kansas
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Lenexa、Kansas、アメリカ、66219
- Johnson County Clin-Trials, Inc. (JCCT)
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Maryland
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Columbia、Maryland、アメリカ、21045
- Centennial Medical Group
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Rockville、Maryland、アメリカ、20850
- Advanced Primary and Geriatric Care
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Massachusetts
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Brookline、Massachusetts、アメリカ、02445
- DM Clinical Research - Brookline
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Minnesota
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Minneapolis、Minnesota、アメリカ、55402
- Clinical Research Institute, Inc.
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Nebraska
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Omaha、Nebraska、アメリカ、68134
- Meridian Clinical Research - Omaha
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New Hampshire
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Newington、New Hampshire、アメリカ、03801
- ActivMed Research LLC
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New York
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Rochester、New York、アメリカ、14609
- Rochester Clinical Research, Inc.
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73112
- Lynn Health Science Institute
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Pennsylvania
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Hatboro、Pennsylvania、アメリカ、19040
- Hatboro Medical Associates/CCT Research
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Rhode Island
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Providence、Rhode Island、アメリカ、02886
- Velocity Clinical Research Providence
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Texas
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Fort Worth、Texas、アメリカ、76135
- Benchmark Research
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Tomball、Texas、アメリカ、77375
- DM Clinical Research
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Virginia
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Charlottesville、Virginia、アメリカ、22911
- Charlottesville Medical Research Center, LLC
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
包含基準:
- スクリーニング訪問時のBMIが18〜39キログラム/平方メートル（両端を含む）。
- 妊娠の可能性のない参加者も研究に登録できる。
- 妊娠の可能性のある女性参加者：妊娠検査が陰性、適切な避妊を行っているか、研究介入期間中に妊娠を引き起こす可能性のあるすべての活動を控えており、最後の研究注射後3か月間適切な避妊または禁欲を継続することに同意している。
除外基準:
- ライム病に関連する慢性疾患がある、または医師によって疑いまたは診断された活動性の症候性ライム病感染症がある。
- 過去 3 か月以内にライム病の治療を受けた。
- 過去にライム病の予防接種を受けたことがある、または過去にライム病のワクチン研究に参加したことがある。
- -治験注射来院前の4週間以内にダニに刺された。
- 局所的なAR評価に影響を与える可能性のある皮膚疾患（例：タトゥー、三角筋領域上の皮膚に影響を与える乾癬斑）。
- -スクリーニング来院前180日以内に合計14日を超える全身免疫抑制剤の投与（コルチコステロイドの場合、プレドニゾンまたは同等の10ミリグラム/日以上）を投与されているか、または研究参加中のいつでも全身免疫抑制治療の必要性が予想される。
- 過去の病歴の時期に関係なく、心筋炎、心膜炎、または心膜炎の病歴。
- -研究注射に含まれる1つ以上の同じ成分を含むワクチンまたは介入を受けた後に、アナフィラキシー、蕁麻疹、または医療介入を必要とするその他の重大な副作用の病歴。
- -スクリーニング訪問前の90日以内に全身免疫グロブリン、免疫応答に影響を与える長時間作用型生物学的療法（インフリキシマブなど）または血液製剤を受けているか、または研究中にそれらを受ける予定がある。
注: 他の包含基準および除外基準が適用される場合があります。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：mRNA-1975: 用量 1
参加者は、1日目、57日目、および169日目に用量レベル1のmRNA-1975ワクチンの筋肉内（IM）注射を3回受けます。
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分散配信IM
他の名前：
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実験的：mRNA-1975: 投与量 2
参加者は、1日目、57日目、および169日目に用量レベル2のmRNA-1975ワクチンの3回のIM注射を受けます。
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分散配信IM
他の名前：
|
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実験的：mRNA-1975: 3 回投与
参加者は、1日目、57日目、および169日目に用量レベル3のmRNA-1975ワクチンのIM注射を3回受けます。
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分散配信IM
他の名前：
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実験的：mRNA-1975: 投与量 4
参加者は、1日目、57日目、および169日目に用量レベル4のmRNA-1975ワクチンのIM注射を3回受けます。
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分散配信IM
他の名前：
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実験的：mRNA-1982: 用量 1
参加者は、1日目、57日目、および169日目に用量レベル1のmRNA-1982ワクチンのIM注射を3回受けます。
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分散配信IM
他の名前：
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実験的：mRNA-1982: 投与量 2
参加者は、1日目、57日目、および169日目に用量レベル2のmRNA-1982ワクチンの3回のIM注射を受けます。
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分散配信IM
他の名前：
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実験的：mRNA-1982: 3 回投与
参加者は、1日目、57日目、および169日目に用量レベル3のmRNA-1982ワクチンのIM注射を3回受けます。
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分散配信IM
他の名前：
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プラセボコンパレーター：プラセボ
参加者は、1日目、57日目、169日目にワクチン適合プラセボの3回のIM注射を受けます。
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ソリューションが提供する IM
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
時間枠：Days 1, 29, 85 and 197
|
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
時間枠：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 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
時間枠：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 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.
|
Days 1, 29, 85 and 197
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-4 Antigen Measured by ELISA
時間枠：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 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.
|
Days 1, 29, 85 and 197
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-5 Antigen Measured by ELISA
時間枠：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.
|
Days 1, 29, 85 and 197
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-6 Antigen Measured by ELISA
時間枠：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 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.
|
Days 1, 29, 85 and 197
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-7 Antigen Measured by ELISA
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Deaths Related to Study Drug
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年7月26日
一次修了 (実際)
2025年5月30日
研究の完了 (実際)
2025年5月30日
試験登録日
最初に提出
2023年7月26日
QC基準を満たした最初の提出物
2023年7月26日
最初の投稿 (実際)
2023年8月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月30日
QC基準を満たした最後の更新が送信されました
2026年7月6日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- mRNA-1975/1982-P101
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。