A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive
NCT ID: NCT04528719
Last Updated: 2024-08-07
Study Results
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Basic Information
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COMPLETED
PHASE1
651 participants
INTERVENTIONAL
2020-09-30
2024-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cohort 1: Dose A in Younger Adults
Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 2: Dose B in Younger Adults
Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 3: Dose B in Younger Adults
Three total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 4: Dose C in Younger Adults
Single injection of Dose C of mRNA-1345 or matching-placebo on Day 1.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 5: Dose D in Children
Three total injections, 1 injection of either Dose D of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 6: Dose G in Children
Three total injections, 1 injection of either Dose G of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 7: Dose A in Older Adults
Two total injections, 1 injection of either Dose A of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 8: Dose B in Older Adults
Two total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 9: Dose C in Older Adults
Two total injections, 1 injection of either Dose C of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 10: Dose E in Older Adults
Two total injections, 1 injection of either Dose E of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 11: Dose F in Older Adults
Two total injections, 1 injection of either Dose F of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 12: Dose E in Women of Child-Bearing Potential
Single injection of Dose E of mRNA-1345 or matching-placebo on Day 1.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 13: Dose F in Women of Child-Bearing Potential
Single injection of Dose F of mRNA-1345 or matching-placebo on Day 1.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 14: Dose A in Women of Child-Bearing Potential
Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 15: Dose B in Japanese Older Adults
Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1.
mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Interventions
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mRNA-1345
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Eligibility Criteria
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Inclusion Criteria
* Willing and physically able to comply with protocol-mandated follow-up, including all procedures.
* Adult participant or parent(s)/legal guardian(s) of pediatric participants has provided written informed consent for participation in this study, including all evaluations and procedures as specified by the protocol.
* Has a body mass index (BMI) from ≥18 kilogram (kg)/meter (m)\^2 to ≤35 kg/m\^2.
* Female participants of non-child-bearing potential. This criterion does not apply for women of child-bearing potential Cohorts 12, 13, and 14.
* Female participants of child-bearing potential may be enrolled in the study, if the participant: 1) has a negative urine pregnancy test at Screening and on the day of vaccination; 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination; 3) has agreed to continue adequate contraception through 3 months following the last injection; and 4) is not currently breastfeeding.
* Seropositive for RSV-neutralizing Abs at Screening.
* Has received routine immunizations appropriate for age per local guidance.
* Current height and weight above the third percentile for age.
* Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.
Exclusion Criteria
* Is acutely ill or febrile on the day of the first injection.
* Has a significant medical history, including but not limited to:
* Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection.
* Chronic hepatitis or suspected active hepatitis.
* Bleeding disorder that is considered a contraindication to intramuscular (IM) injection or phlebotomy.
* Dermatologic conditions that could affect local solicited AR assessments.
* Any history of allergic or anaphylactic reactions following a vaccination that required medical intervention.
* Autoimmune disease except for Hashimoto's disease.
* Systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to the day of enrollment. Topical tacrolimus is allowed if not used within 14 days prior to the day of enrollment. Inhaled, nasal, and topical steroids are allowed.
* Intravenous blood products (red cells, platelets, and immunoglobulins \[Ig\]) within 3 months prior to enrollment.
* Has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤ 28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection. Nonstudy vaccinations should not be delayed.
* Has a history of myocarditis, pericarditis, or myopericarditis.
* Known history of poorly controlled hypertension (per determination of the Investigator) or systolic blood pressure \>160 millimeters of mercury (mmHg) at the Screening visit.
* Known history of hypotension or systolic blood pressure \<85 mmHg at the Screening visit.
* Poorly controlled diabetes mellitus (per determination of the Investigator).
* Diagnosis of significant chronic pulmonary disease (per determination of the Investigator) (such as, chronic obstructive pulmonary disease, asthma).
* Significant chronic cardiovascular disease (per determination of the Investigator).
* Resides in a nursing home.
* Anticipates the need for immunosuppressive treatment at any time during participation in the study.
* Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer and cervical carcinoma in-situ).
* Has received any monoclonal antibody at any time prior to Screening.
* Prior hospitalization for RSV disease in the last 2 years.
* Receipt of any prior systemic immunosuppressants or immune-modifying drugs.
* Any history of febrile seizures (inclusive of single simple febrile seizure).
* History of epilepsy.
* History of meningitis.
12 Months
79 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
La Mesa, California, United States
Mills Clinical Research
West Hollywood, California, United States
Accel Research Site - Angel Kids Pediatrics - ERN - PPDS
DeLand, Florida, United States
Accel Research Sites - Nona Pediatric Center - ERN - PPDS
Orlando, Florida, United States
Palm Beach Research - ClinEdge - PPDS
West Palm Beach, Florida, United States
Centricity Research - Roswell - HyperCore - PPDS
Columbus, Georgia, United States
IResearch Atlanta LLC
Decatur, Georgia, United States
Velocity Clinical Research (Savannah - Georgia) - PPDS
Savannah, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Synexus - Optimal Research - Peoria
Peoria, Illinois, United States
Velocity Clinical Research (Sioux City - Iowa) - PPDS
Sioux City, Iowa, United States
Michael W. Simon, M.D., PSC
Nicholasville, Kentucky, United States
Velocity Clinical Research (Lafayette - Louisiana) - PPDS
Lafayette, Louisiana, United States
Velocity Clinical Research (Metaire - Louisiana) - PPDS
Metairie, Louisiana, United States
Velocity Clinical Research (Slidell - Louisiana) - PPDS
Slidell, Louisiana, United States
Henry Ford Health System
Detroit, Michigan, United States
Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri, United States
Velocity Clinical Research (Grand Island - Nebraska) - PPDS
Grand Island, Nebraska, United States
Velocity Clinical Research (Hastings - Nebraska) - PPDS
Hastings, Nebraska, United States
Velocity Clinical Research (Norfolk - Nebraska) - PPDS
Norfolk, Nebraska, United States
Velocity Clinical Research (Omaha - Nebraska) - PPDS
Omaha, Nebraska, United States
Velocity Clinical Research (Albuquerque - New Mexico) - PPDS
Albuquerque, New Mexico, United States
Velocity Clinical Research (Binghamton - New York) - PPDS
Binghamton, New York, United States
Velocity Clinical Research - Medford - ERN - PPDS
Medford, Oregon, United States
Velocity Clinical Research - Columbia - PPDS
Columbia, South Carolina, United States
Velocity Clinical Research (Greenville - South Carolina) - PPDS
Greenville, South Carolina, United States
Cyfair Clinical Research Center - ERN - PPDS
Houston, Texas, United States
Flourish Research - San Antonio - PPDS
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Tanner Clinic
Layton, Utah, United States
Clinical Research Partners LLC
Richmond, Virginia, United States
Countries
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References
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Schnyder Ghamloush S, Fanning S, Essink B, Eder F, Snape MD, Stoszek SK, Guo R, Dhar R, Righi V, Morsy L, Kapoor A, El Asmar L, Shaw CA. Safety and immunogenicity of an mRNA-based RSV vaccine in seropositive children aged 12-59 months. Hum Vaccin Immunother. 2025 Dec;21(1):2557676. doi: 10.1080/21645515.2025.2557676. Epub 2025 Sep 15.
Fitz-Patrick D, Mihara H, Mills A, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Simorellis AK, Panozzo CA, Reuter C, Wilson E, Chen GL, Stoszek SK, Shaw CA, Goswami J. Safety and immunogenicity of an mRNA-based RSV vaccine in Japanese older adults aged >/=60 years: A phase 1, randomized, observer-blind, placebo-controlled trial. Respir Investig. 2024 Nov;62(6):1037-1043. doi: 10.1016/j.resinv.2024.08.011. Epub 2024 Sep 9.
Shaw CA, Essink B, Harper C, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Panozzo CA, Wilson E, Simorellis AK, Reuter C, Stoszek SK, Chen GL, Das R, Goswami J. Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults. J Infect Dis. 2024 Sep 23;230(3):e647-e656. doi: 10.1093/infdis/jiae081.
Shaw CA, Mithani R, Kapoor A, Dhar R, Wilson L, El Asmar L, Schnyder-Ghamloush S, Schaefers K, August A, Stoszek SK, Chen GL. Safety, Tolerability, and Immunogenicity of an mRNA-Based Respiratory Syncytial Virus Vaccine in Healthy Young Adults in a Phase 1 Clinical Trial. J Infect Dis. 2024 Sep 23;230(3):e637-e646. doi: 10.1093/infdis/jiae035.
Other Identifiers
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mRNA-1345-P101
Identifier Type: -
Identifier Source: org_study_id
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