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A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05127434
Recruitment Status : Active, not recruiting
First Posted : November 19, 2021
Last Update Posted : February 9, 2024
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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Brief Summary:

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months.

The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.


Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Drug: Placebo Drug: mRNA-1345 Phase 2 Phase 3

Detailed Description:

The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Part A Phase 2 segment, up to 2,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.

In the Part A Phase 3 segment, approximately 35,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.

In the Part B substudy, 1500 participants who received a dose of mRNA-1345 in Part A Phase 3 will be randomly assigned in a 2:1 randomization ratio to receive a single BD injection of either mRNA-1345 at the selected dose or placebo.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36557 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age
Actual Study Start Date : November 17, 2021
Estimated Primary Completion Date : August 25, 2025
Estimated Study Completion Date : August 25, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: mRNA-1345
Single injection of mRNA-1345 on Day 1.
 Drug: mRNA-1345
Sterile liquid for injection
Experimental: Placebo
Single injection of mRNA-1345 matching-placebo on Day 1.
 Drug: Placebo
0.9% sodium chloride (normal saline) injection
Experimental: mRNA-1345 BD
Single injection of mRNA-1345 on BD Day 1.
 Drug: mRNA-1345
Sterile liquid for injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to 7 days after each injection ]
  2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to 28 days after each injection ]
  3. Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal [ Time Frame: Up to BD Day 181 ]
  4. Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms [ Time Frame: From 14 days postinjection up to 12 months postinjection ]
    VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).

  5. VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms [ Time Frame: From 14 days postinjection up to 12 months postinjection ]
    VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).

  6. Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies [ Time Frame: BD Day 29 ]
  7. Geometric Mean Ratio (GMR) of Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose [ Time Frame: BD Day 29 ]

Secondary Outcome Measures :
  1. VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD) [ Time Frame: From 14 days postinjection up to 12 months postinjection ]
    VE of mRNA-1345 to prevent RT-PCR confirmed protocol-defined RSV-ARD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).

  2. VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD [ Time Frame: From 14 days postinjection up to 12 months postinjection ]
    VE of mRNA-1345 to prevent first hospitalization associated with RSV-ARD or RSV-LRTD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).

  3. GMT of Serum RSV Neutralizing Antibodies [ Time Frame: Baseline through up to 24 months postinjection ]
  4. Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies [ Time Frame: Baseline through up to 24 months postinjection ]
  5. Seroresponse Rate in RSV Neutralizing Antibodies [ Time Frame: Baseline through up to 24 months postinjection ]
  6. Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Antibody Titers [ Time Frame: Baseline through up to 24 months postinjection ]
  7. Proportion of Participants with ≥4-fold Increases in Antibody Titers from Baseline [ Time Frame: Baseline through up to 24 months postinjection ]
  8. Seroresponse Rate (SRR) Difference Between Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose [ Time Frame: BD Day 29 ]
  9. GMT of Serum RSV-A and RSV-B Neutralizing Antibodies [ Time Frame: BD Day 1 and Day 181 ]
  10. GMFR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline) [ Time Frame: Baseline, BD Day 1, Day 29 and Day 181 ]
  11. SRR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline) [ Time Frame: Baseline, BD Day 1, Day 29 and Day 181 ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria (Part A):

  • Adults ≥ 60 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (including chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable
  • Body mass index from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2

Key Inclusion Criteria (Part B):

  • Randomized to and were subsequently vaccinated with the mRNA-1345 study injection in Part A at least 21 months prior to Screening.

Key Exclusion Criteria (Part A):

  • Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the Day 1 study injection.
  • Current participation in research involving receipt of any investigational RSV product
  • History of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
  • Received or plans to receive any non-study vaccine within 28 days before or after the Day 1 study injection.

Key Exclusion Criteria (Part B):

  • Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of BD study injection (BD Day 1).
  • History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
  • Received or plans to receive any non-study vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 (COVID-19) regardless of type of vaccine) within 14 days before or after the BD Day 1 study injection.
  • Received or plans to receive any commercial RSV vaccination at any time prior to BD study injection (BD Day 1) or during the substudy.

Other inclusion and/or exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05127434


Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05127434    
Other Study ID Numbers: mRNA-1345-P301
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: February 9, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
Viral Diseases
Messenger RNA
Moderna
mRNA-1345
 Respiratory syncytial virus
Safety
Vaccines
Additional relevant MeSH terms:
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Virus Diseases
Infections