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The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to <18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: mRNA-1189 Dose Level 2 | Experimental | Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169. |
|
| Part A: mRNA-1189 Dose Level 3 | Experimental | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169. |
|
| Part A: mRNA-1189 Dose Level 4 | Experimental | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169. |
|
| Part A: Placebo | Placebo Comparator | Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169. |
|
| Part B: mRNA-1189 Dose Level 1 | Experimental | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169. |
|
| Part B: mRNA-1189 Dose Level 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1189 | 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 SAEs, MAAEs, Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs) | Day 1 to end of study (EOS) (Day 505) | |
| Number of Participants with Laboratory Abnormalities | Up to Day 176 (7-day follow-up after vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) | Days 1, 85, and 197 | |
| Geometric Mean Concentration (GMC) of Antigen-specific Binding Antibody (bAb) | Days 1, 85, and 197 | |
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Inclusion Criteria:
Part A: Healthy adult from 18 to 30 years of age (inclusive) at the time of consent (Screening Visit, Day 0).
Part B:
Healthy baseline EBV-seronegative adolescents from 12 to <18 years of age at the time of consent (Screening Visit, Day 0).
Part C:
Healthy adolescents and adults from 10 to 21 years of age (inclusive) at the time of consent (Screening Visit, Day 0).
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affiliated Research Institute | Huntsville | Alabama | 35801 | United States | ||
| Smart Cures Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38957951 | Derived | Malpica L, Marques-Piubelli ML, Beltran BE, Chavez JC, Miranda RN, Castillo JJ. EBV-positive diffuse large B-cell lymphoma, not otherwise specified: 2024 update on the diagnosis, risk-stratification, and management. Am J Hematol. 2024 Oct;99(10):2002-2015. doi: 10.1002/ajh.27430. Epub 2024 Jul 3. |
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| Experimental |
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169. |
|
| Part B: mRNA-1189 Dose Level 3 | Experimental | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169. |
|
| Part B: mRNA-1189 Dose Level 4 | Experimental | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169. |
|
| Part B: Placebo | Placebo Comparator | Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169. |
|
| Part C: mRNA-1189 Dose Level 1 | Experimental | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169. |
|
| Part C: mRNA-1189 Dose Level 2 | Experimental | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169. |
|
| Part C: mRNA-1189 Dose Level 3 | Experimental | Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169. |
|
| Part C: Placebo | Placebo Comparator | Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169. |
|
| Placebo | Biological | 0.9% sodium chloride (normal saline) injection |
|
| Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-specific bAb |
| Days 1, 85, and 197 |
| Number of Participants with Seroresponse of B-Cell nAbs and Antigen-specific bAbs | The number of participants with seroresponse for EBV-specific (vaccine antigen) binding and nAbs responses and with >2-, 3-, and 4-fold increases in serum binding or nAb titers from baseline will be analyzed with 2-sided 95% CI using the Clopper-Pearson method by treatment arm and baseline EBV serostatus, and timepoint. | Days 1, 85, and 197 |
| Anaheim |
| California |
| 92806 |
| United States |
| Benchmark Research - Colton - HyperCore - PPDS | Colton | California | 92324 | United States |
| Fomat Medical Research | Oxnard | California | 93030 | United States |
| Center For Clinical Trials LLC -Paramount | Paramount | California | 90723-5459 | United States |
| Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS | Riverside | California | 92503 | United States |
| Peninsula Research Associates - Headlands Research - PPDS | Rolling Hills | California | 90274 | United States |
| Velocity Clinical Research - Banning - PPDS | San Bernardino | California | 92220-3082 | United States |
| Acclaim Clinical Research | San Diego | California | 92120 | United States |
| California Research Foundation - 4180 Ruffin Rd | San Diego | California | 92123-1881 | United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| CenExel iResearch, LLC | Hollywood | Florida | 33024 | United States |
| Jacksonville Center For Clinical Research - ERN - PPDS | Jacksonville | Florida | 32216-4357 | United States |
| iResearch Savannah - CenExel - PPDS | Savannah | Georgia | 31405 | United States |
| Velocity Clinical Research - Savannah | Savannah | Georgia | 31406 | United States |
| Clinical Research Atlanta - Headlands - PPDS | Stockbridge | Georgia | 30281-9054 | United States |
| Velocity Clinical Research | Meridian | Idaho | 83642 | United States |
| Olivo Medical and Wellness Center | Chicago | Illinois | 60618-8101 | United States |
| DM Clinical Research | River Forest | Illinois | 60305 | United States |
| Velocity Clinical Research | Valparaiso | Indiana | 46383 | United States |
| Velocity Clinical Research - Sioux City | Sioux City | Iowa | 51106 | United States |
| Alliance for Multispecialty Research, LLC - El Dorado - PPDS | El Dorado | Kansas | 67042-2187 | United States |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
| Alliance for Multispecialty Research LLC, East Wichita | Wichita | Kansas | 67207 | United States |
| Michael W Simon MD, PSC | Lexington | Kentucky | 40517-8379 | United States |
| Velocity Clinical Research - Lafayette - PPDS | Lafayette | Louisiana | 70508-5173 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01605 | United States |
| Great Lakes Research Institute | Southfield | Michigan | 48075 | United States |
| DM Clinical Research | Southfield | Michigan | 48076 | United States |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | United States |
| Sundance Clinical Research - ERN - PPDS | St Louis | Missouri | 63141 | United States |
| Velocity Clinical Research - Grand Island | Grand Island | Nebraska | 68803 | United States |
| Velocity Clinical Research - Lincoln | Lincoln | Nebraska | 68510 | United States |
| Velocity Clinical Research - Norfolk | Norfolk | Nebraska | 68701 | United States |
| Quality Clinical Research - ClinEdge - PPDS | Omaha | Nebraska | 68112 | United States |
| Velocity Clinical Research - Omaha | Omaha | Nebraska | 68134 | United States |
| Alliance for Multispecialty Research, LLC | Las Vegas | Nevada | 89119 | United States |
| Velocity Clinical Research - Binghamton | Binghamton | New York | 13901 | United States |
| Velocity Clinical Research | East Syracuse | New York | 13057 | United States |
| Velocity Clinical Research - Vestal | Vestal | New York | 13850 | United States |
| Lucas Research | Morehead City | North Carolina | 28557 | United States |
| Lucas Research | New Bern | North Carolina | 28562 | United States |
| Velocity Clinical Research - Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Senders Pediatrics | South Euclid | Ohio | 44121 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Velocity Clinical Research | Anderson | South Carolina | 29621 | United States |
| Coastal Pediatric Associates | Charleston | South Carolina | 29414-5834 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Benchmark Research - Austin - PPDS | Austin | Texas | 78705 | United States |
| Tekton Research - Texas - Platinum - PPDS | Austin | Texas | 78745 | United States |
| ACRC Trials - Hunt - PPDS | Carrollton | Texas | 75010 | United States |
| Velocity Clinical Research - Austin - PPDS | Cedar Park | Texas | 78613-3936 | United States |
| Cedar Health Research - Fort Worth - PPDS | Dallas | Texas | 75251 | United States |
| Benchmark Research - Fort Worth - HyperCore - PPDS | Fort Worth | Texas | 76135 | United States |
| ACRC Trials | Frisco | Texas | 75024 | United States |
| Helios Clinical Research | Houston | Texas | 77008 | United States |
| DM Clinical Research - Texas Center For Drug Development - ERN - PPDS | Houston | Texas | 77065 | United States |
| ACRC Trials - Legacy Medical Village Headquarters | Plano | Texas | 75024-4174 | United States |
| DM Clinical Research - Texas Center For Drug Development - ERN - PPDS | Tomball | Texas | 77375 | United States |
| Victoria Clinical Research Group | Victoria | Texas | 77979 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| Charlottesville Medical Research Center | Charlottesville | Virginia | 22911 | United States |
| Health Research of Hampton Roads Inc. - Newport News | Newport News | Virginia | 23606-4537 | United States |
| Alliance for Multispecialty Research, LLC | Norfolk | Virginia | 23502 | United States |
| Clinical Research Partners LLC - Richmond - ERN - PPDS | Richmond | Virginia | 23226-3787 | United States |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D007244 | Infectious Mononucleosis |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | 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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