A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus Seropositive

Study Purpose

The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of 1 of 3 dose levels of mRNA-1345 in younger adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Months - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Healthy young adults ≥18 to ≤49 years of age, healthy older adults ≥65 to <80 years of age, and children ≥12 to < 60 months of age.
  • - 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.
Specific inclusion criteria for younger and older adults:
  • - Has a body mass index (BMI) from ≥18 kilogram (kg)/meter (m)^2 and ≤35 kg/m^2.
  • - Female participants of nonchildbearing potential.
  • - Female participants of childbearing 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.
Specific inclusion criteria for children 12 to 59 months of age:
  • - 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.

Exclusion Criteria:

  • - Has Screening laboratory values Grade ≥1.
  • - 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.
  • - Receipt of: - Inactivated vaccine(s) within 14 days prior to first injection; or, plans to receive inactivated vaccine(s) within 14 days prior to and through 14 days following each study injection, with the exception of any COVID-19 vaccine (regardless of type of vaccine) that becomes available to the participant during the study; efforts should be made to space study vaccinations and COVID-19 vaccinations by at least 7 and preferably 14 days, but COVID-19 vaccinations should not be delayed.
  • - Live virus vaccine(s) within 28 days prior to first injection; or, plans to receive live virus vaccine(s) within 28 days prior to and through 28 days following each study injection.
  • - 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 a drug product containing lipid nanoparticles (LNPs) within 14 days before enrollment, with the exception of any COVID-19 vaccine (regardless of type of vaccine) that becomes available to the participant during the study; efforts should be made to space study vaccinations and COVID-19 vaccinations by at least 7 and preferably 14 days, but COVID-19 vaccinations should not be delayed.
Specific exclusion criteria for older adults 65 to 79 years of age:
  • - 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).
Specific exclusion criteria for children 12 to 59 months of age:
  • - Has received any monoclonal antibody at any time prior to Screening.
  • - Prior hospitalization for RSV disease (confirmed by polymerase chain reaction).
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04528719
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ModernaTX, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Respiratory Syncytial Virus
Arms & Interventions

Arms

Experimental: Cohort 1: Dose A in Younger Adults

Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1.

Experimental: Cohort 2: Dose B in Younger Adults

Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1.

Experimental: 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.

Experimental: Cohort 4: Dose C in Younger Adults

Single injection of Dose C of mRNA-1345 or matching-placebo on Day 1.

Experimental: 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.

Experimental: Cohort 6: Dose B in Children

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.

Experimental: 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

Experimental: 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

Experimental: 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

Interventions

Biological: - mRNA-1345

Formulation for injection

Drug: - Placebo

0.9% sodium chloride (normal saline) injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. Please note all sites listed may not currently be active in the trial. Please continue to check back for additional site locations.

Baptist Health Center for Clinical Research
Recruiting | Little Rock, Arkansas, United States, 72205
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Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
Recruiting | La Mesa, California, United States, 91942-3189
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Palm Beach Research - ClinEdge - PPDS
Recruiting | Palm Springs, California, United States, 92262
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IResearch Atlanta LLC
Recruiting | Decatur, Georgia, United States, 30030-3438
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IACT Health - IACT - PPDS
Recruiting | Roswell, Georgia, United States, 30076-0927
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Clinical Research Atlanta - ERN-PPDS
Recruiting | Stockbridge, Georgia, United States, 30281-9054
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Synexus - Optimal Research - Peoria
Recruiting | Peoria, Illinois, United States, 61614
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Heartland Research Associates - Newton
Recruiting | Newton, Kansas, United States, 67114-9017
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Medpharmics
Recruiting | Metairie, Louisiana, United States, 70006
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Brigham and Womens Hospital
Recruiting | Boston, Massachusetts, United States, 02115
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Henry Ford Health System
Recruiting | Novi, Michigan, United States, 48377
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Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS
Recruiting | Norfolk, Nebraska, United States, 68701-2669
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Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS
Recruiting | Omaha, Nebraska, United States, 68134
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MedPharmics, LLC. - Albuquerque
Recruiting | Albuquerque, New Mexico, United States, 87102-3876
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Global Medical Research - M3 WR - ERN - PPDS
Recruiting | Raleigh, North Carolina, United States, 27612-8104
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Velocity Clinical Research - Medford - ERN - PPDS
Recruiting | Medford, Oregon, United States, 97504-9741
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Keystone VitaLink Research - Greenville - PPDS
Recruiting | Greenville, South Carolina, United States, 29615-4833
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Keystone VitaLink Research - Spartanburg - PPDS
Recruiting | Spartanburg, South Carolina, United States, 29303-4225
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Center For Pharmaceutical Research
Recruiting | Dallas, Texas, United States, 75235-6262
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Clinical Trials of Texas, Inc. - PPDS
Recruiting | San Antonio, Texas, United States, 78229-3539
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Tanner Clinic
Recruiting | Layton, Utah, United States, 84041
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