Brief Summary
The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to \<60 years.
Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
Brief Title
A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Respiratory Syncytial Virus
Eligibility Criteria
Key Inclusion Criteria:
Part A:
* Adults ≥18 to \<60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Documented confirmation by a physician of the diagnosis of at least one of the following conditions:
1. Coronary artery disease and/or congestive heart failure.
2. Chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma).
3. Stable type 1 or type 2 diabetes mellitus controlled with at least 1 medication started 90 days or more prior to Day 1.
Part B:
* Adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Recipient of an SOT (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection.
Parts A and B:
- Able to comply with study requirements.
Key Exclusion Criteria:
Part A:
* Participation in an another clinical research trial where the participant has received an investigational product 180 days prior to Day 1. Participation in an RSV trial at any time prior to Day 1 is exclusionary.
* History of a diagnosis or condition, that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1345 injection or any components of the mRNA-1345 injection.
* Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 180 days prior to Day 1.
* History of myocarditis, pericarditis, or myopericarditis.
Part B:
* Previous treatment with alemtuzumab or rituximab within 2 years prior to Day 1.
* Previous treatment with plasmapheresis within 30 days prior to Day 1.
* A history of complications of immunosuppression.
* A history of biopsy proven or clinically diagnosed rejection within 90 days prior to Day 1 or suspected active chronic rejection according to the Investigator's judgment.
Note: Other protocol-defined inclusion/exclusion criteria apply
Part A:
* Adults ≥18 to \<60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Documented confirmation by a physician of the diagnosis of at least one of the following conditions:
1. Coronary artery disease and/or congestive heart failure.
2. Chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma).
3. Stable type 1 or type 2 diabetes mellitus controlled with at least 1 medication started 90 days or more prior to Day 1.
Part B:
* Adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Recipient of an SOT (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection.
Parts A and B:
- Able to comply with study requirements.
Key Exclusion Criteria:
Part A:
* Participation in an another clinical research trial where the participant has received an investigational product 180 days prior to Day 1. Participation in an RSV trial at any time prior to Day 1 is exclusionary.
* History of a diagnosis or condition, that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1345 injection or any components of the mRNA-1345 injection.
* Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 180 days prior to Day 1.
* History of myocarditis, pericarditis, or myopericarditis.
Part B:
* Previous treatment with alemtuzumab or rituximab within 2 years prior to Day 1.
* Previous treatment with plasmapheresis within 30 days prior to Day 1.
* A history of complications of immunosuppression.
* A history of biopsy proven or clinically diagnosed rejection within 90 days prior to Day 1 or suspected active chronic rejection according to the Investigator's judgment.
Note: Other protocol-defined inclusion/exclusion criteria apply
Inclusion Criteria
Inclusion Criteria:
Part A:
* Adults ≥18 to \<60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Documented confirmation by a physician of the diagnosis of at least one of the following conditions:
1. Coronary artery disease and/or congestive heart failure.
2. Chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma).
3. Stable type 1 or type 2 diabetes mellitus controlled with at least 1 medication started 90 days or more prior to Day 1.
Part B:
* Adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Recipient of an SOT (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection.
Parts A and B:
- Able to comply with study requirements.
inclusion/
Part A:
* Adults ≥18 to \<60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Documented confirmation by a physician of the diagnosis of at least one of the following conditions:
1. Coronary artery disease and/or congestive heart failure.
2. Chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma).
3. Stable type 1 or type 2 diabetes mellitus controlled with at least 1 medication started 90 days or more prior to Day 1.
Part B:
* Adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Recipient of an SOT (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection.
Parts A and B:
- Able to comply with study requirements.
inclusion/
Gender
All
Gender Based
false
Keywords
Viral Diseases
Messenger RNA
Moderna
mRNA-1345
Respiratory syncytial virus
Safety
Vaccines
Immunocompromised
Organ transplant
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06067230
Org Class
Industry
Org Full Name
ModernaTX, Inc.
Org Study Id
mRNA-1345-P303
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults
Primary Outcomes
Outcome Measure
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Outcome Time Frame
Day 1 through Day 7 (7 days post injection) for Part A and Day 1 through Day 64 (7 days post second injection) for Part B
Outcome Measure
Number of Participants with Unsolicited Adverse Events (AEs)
Outcome Time Frame
Day 1 through Day 28 (28 days post injection) for Part A and Day 1 through Day 84 (28 days post second injection) for Part B
Outcome Measure
Number of Participants With Medically Attended AEs (MAAEs)
Outcome Time Frame
Day 1 through Month 6 (for Part A) and Day 1 through Month 9 (for Part B)
Outcome Measure
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
Outcome Time Frame
Day 1 through End of Study (Day 730)
Outcome Measure
Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (Abs) at Day 29
Outcome Time Frame
Day 29
Outcome Measure
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85
Outcome Time Frame
Day 85
Secondary Outcomes
Outcome Time Frame
Day 29
Outcome Measure
Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion Conformation of the F Protein (Pre-F) Binding Abs
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part A: Geometric Mean Fold-Rise (GMFR) of Serum RSV Pre-F Binding Abs
Outcome Time Frame
Baseline up to Day 730
Outcome Measure
Part A: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part A: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs
Outcome Time Frame
Day 29
Outcome Measure
Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Outcome Time Frame
Baseline up to Day 730
Outcome Measure
Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Outcome Time Frame
Baseline up to Day 730
Outcome Measure
Part A: GMFR of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part A: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers
Outcome Time Frame
Day 29
Outcome Measure
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Outcome Time Frame
Day 29
Outcome Measure
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29
Outcome Time Frame
Day 85
Outcome Measure
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part B: GMC of Serum RSV-A and RSV-B Neutralizing Abs
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part B: GMFR of Serum RSV-A and RSV-B Neutralizing Abs
Outcome Time Frame
Baseline up to Day 730
Outcome Measure
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs at Postbaseline/Baseline Levels
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part B: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part B: GMC of Serum RSV Pre-F Binding Abs
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part B: GMFR of Serum RSV Pre-F Binding Abs
Outcome Time Frame
Baseline up to End of Study (Day 730)
Outcome Measure
Part B: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels
Outcome Time Frame
Up to End of Study (Day 730)
Outcome Measure
Part B: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Locked Fields
Render the field
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18