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The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.
There will be 2 sequential parts to the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: mRNA-1195.1 Dose Level 1 | Experimental | Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169. |
|
| Part A: mRNA-1195.2 Dose Level 1 | Experimental | Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169. |
|
| Part A: mRNA-1195.1 Dose Level 2 | Experimental | Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169. |
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| Part A: mRNA-1195.2 Dose Level 2 | Experimental | Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169. |
|
| Part A: mRNA-1195.1 Dose Level 3 | Experimental | Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169. |
|
| Part A: mRNA-1195.2 Dose Level 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1195.1 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 176 (7-day follow-up after vaccination) | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 197 (28-day follow-up after vaccination) | |
| Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Discontinuation of Study Intervention and/or Study Participation, and AEs of Special Interest (AESIs) | Part A and B: Day 1 to end of study (EOS) (Part A: Day 337; Part B: Day 505) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb) | Days 1, 85, and 197 | |
| Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or Antigen-Specific bAb | Days 1, 85, and 197 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Noble Clinical Research |
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| Experimental |
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169. |
|
| Part A: mRNA-1195.1 Dose Level 4 | Experimental | Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169. |
|
| Part A: mRNA-1195.2 Dose Level 4 | Experimental | Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169. |
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| Part A: mRNA-1189 | Active Comparator | Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169. |
|
| Part A: Placebo | Placebo Comparator | Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169. |
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| Part B: Placebo | Placebo Comparator | Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169. |
|
| Part B: mRNA-1195 Low Dose | Experimental | Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169. |
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| Part B: mRNA-1195 Middle Dose | Experimental | Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169. |
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| Part B: mRNA-1195 High Dose | Experimental | Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169. |
|
| mRNA-1195.2 | Biological | Sterile liquid for injection |
|
| mRNA-1189 | Biological | Sterile liquid for injection |
|
| Placebo | Biological | 0.9% sodium chloride (normal saline) injection |
|
| mRNA-1195 | Biological | Sterile liquid for injection |
|
| Number of Participants With Seroresponse of B-Cell nAbs and/or Antigen-Specific bAbs | Days 1, 85, and 197 |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Marvel Clinical Research | Huntington Beach | California | 92647 | United States |
| Tekton Research | Longmont | Colorado | 80501 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| Velocity Clinical Research | Savannah | Georgia | 31406 | United States |
| Optimal Research | Peoria | Illinois | 61614 | United States |
| DM Clinical Research- River Forest | River Forest | Illinois | 60305 | United States |
| Velocity Clinical Research | Sioux City | Iowa | 51106 | United States |
| Johnson County Clin-Trials, Inc (JCCT) | Lenexa | Kansas | 66219 | United States |
| Velocity Clinical Research | Rockville | Maryland | 20854 | United States |
| DM Clinical Research | Brookline | Massachusetts | 02445 | United States |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | United States |
| DM Clinical Research | Southfield | Michigan | 48076 | United States |
| Velocity Clinical Research | Grand Island | Nebraska | 68803 | United States |
| Velocity Clinical Research | Hastings | Nebraska | 68901 | United States |
| Velocity Clinical Research | Lincoln | Nebraska | 68510 | United States |
| Velocity Clinical Research | Norfolk | Nebraska | 68701 | United States |
| Velocity Clinical Research | Omaha | Nebraska | 68134 | United States |
| Las Vegas Clinical Trials, LLC | North Las Vegas | Nevada | 89030 | United States |
| Velocity Clinical Research | Binghamton | New York | 13905 | United States |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | United States |
| Eximia Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Tekton Research, Inc | Edmond | Oklahoma | 73013 | United States |
| Tekton Research | Moore | Oklahoma | 73160 | United States |
| Tekton Research, Inc - Yukon Location | Yukon | Oklahoma | 73099 | United States |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37920 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Tekton Research Inc. | Austin | Texas | 78745 | United States |
| DM Clinical Research | Houston | Texas | 77065 | United States |
| Research Your Health | Plano | Texas | 75093 | United States |
| DM Clinical Research | Sugar Land | Texas | 77478 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D007244 | Infectious Mononucleosis |
| D014777 | Virus Diseases |
| D007239 | Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014412 | Tumor Virus Infections |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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