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A Study of Modified mRNA Vaccines in Healthy Adults

Primary Purpose

SARS-CoV-2, Seasonal Influenza, Respiratory Syncytial Virus

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-1273
mRNA-1010
mRNA-1345
FLUAD®
mRNA-1647
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV-2 focused on measuring mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna, Influenza vaccine, mRNA-1010, mRNA-1345, Respiratory syncytial virus, RSV Seropositive, Vaccines, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults 18 to 75 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. For mRNA-1647 study arms, adults 18 to <50 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening.
  • Body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the screening visit.

Exclusion Criteria:

  • Participant has had close contact to someone with confirmed SARS-CoV-2, respiratory syncytial virus (RSV), or influenza infection in the past 14 days prior to the screening visit.
  • Severe allergic reaction to any component of the FLUAD vaccine (active comparator), including egg protein, or after a previous dose of any influenza vaccine.
  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (to include any systemic corticosteroids) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Participant plans to receive any licensed or authorized vaccine, including COVID-19 influenza vaccines, within 28 days before or after any study injection.
  • Participant has received a NH 2021 - 2022 or 2022-2023 seasonal influenza vaccine or any other influenza vaccine, or an experimental RSV or cytomegalovirus (CMV) vaccine, within 6 months prior to study Day 1, and/or has not completed a primary vaccination series for COVID-19.
  • Participant has received an authorized or approved COVID-19 vaccine within 4 months prior to Day 1, and/or has not completed a primary vaccination series for COVID-19.
  • Participant had a laboratory-confirmed infection with influenza or RSV within 6 months prior to Day 1, or SARS-CoV-2 within 4 months of Day 1. SARS-CoV-2 infection confirmed with self-administered, authorized or approved rapid antigen test is acceptable.
  • Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study.
  • Participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study.

Other inclusion and exclusion criteria may apply.

Sites / Locations

  • CenExel
  • Meridian Clinical Research
  • Meridian Clinical Research
  • Johnson County Clinical Trials
  • Meridian Clinical Research
  • Benchmark Research
  • Tekton Research, Inc
  • DM Clinical Research- Texas Center for Drug Development

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Part 1: mRNA-1345

Part 1: mRNA-1647 2-Dose

Part 1: mRNA-1647 3-Dose

Part 2: mRNA-1273

Part 2: mRNA-1010

Part 2: FLUAD®

Arm Description

Participants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.

Participants will receive single IM injection of mRNA-1647 on Days 1 and 57.

Participants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.

Participants will receive single IM injection of mRNA-1273 on Day 1

Participants will receive single IM injection of mRNA-1010 on Day 1.

Participants will receive single IM injection of FLUAD® on Day 1.

Outcomes

Primary Outcome Measures

Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Participants With Unsolicited Adverse Events (AEs)
Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination
Number of Participants with Medically Attended Adverse Events (MAAEs)

Secondary Outcome Measures

Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647

Full Information

First Posted
May 25, 2022
Last Updated
May 22, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05397223
Brief Title
A Study of Modified mRNA Vaccines in Healthy Adults
Official Title
Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Modified mRNA Vaccines Using a Systems Biology Approach in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
March 25, 2024 (Anticipated)
Study Completion Date
March 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2, Seasonal Influenza, Respiratory Syncytial Virus, Cytomegalovirus
Keywords
mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna, Influenza vaccine, mRNA-1010, mRNA-1345, Respiratory syncytial virus, RSV Seropositive, Vaccines, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: mRNA-1345
Arm Type
Experimental
Arm Description
Participants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.
Arm Title
Part 1: mRNA-1647 2-Dose
Arm Type
Experimental
Arm Description
Participants will receive single IM injection of mRNA-1647 on Days 1 and 57.
Arm Title
Part 1: mRNA-1647 3-Dose
Arm Type
Experimental
Arm Description
Participants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.
Arm Title
Part 2: mRNA-1273
Arm Type
Experimental
Arm Description
Participants will receive single IM injection of mRNA-1273 on Day 1
Arm Title
Part 2: mRNA-1010
Arm Type
Experimental
Arm Description
Participants will receive single IM injection of mRNA-1010 on Day 1.
Arm Title
Part 2: FLUAD®
Arm Type
Active Comparator
Arm Description
Participants will receive single IM injection of FLUAD® on Day 1.
Intervention Type
Biological
Intervention Name(s)
mRNA-1273
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1010
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1345
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
FLUAD®
Intervention Description
adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine
Intervention Type
Biological
Intervention Name(s)
mRNA-1647
Intervention Description
Sterile lyophilized product
Primary Outcome Measure Information:
Title
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame
Up to Day 176 (7 days follow-up post-vaccination)
Title
Number of Participants With Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 197 (28 days follow-up post-vaccination)
Title
Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination
Time Frame
Day 1 through end of study (EOS) (up to Day 1249)
Title
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time Frame
Day 1 through Day 361
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Time Frame
Days 1 (Baseline), 29, 85, and 197
Title
Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Time Frame
Days 1 (Baseline), 29, 85, and 197
Title
Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647
Time Frame
Days 1 (Baseline), 29, 85, and 197

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults 18 to 75 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. For mRNA-1647 study arms, adults 18 to <50 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. Body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the screening visit. Exclusion Criteria: Participant has had close contact to someone with confirmed SARS-CoV-2, respiratory syncytial virus (RSV), or influenza infection in the past 14 days prior to the screening visit. Severe allergic reaction to any component of the FLUAD vaccine (active comparator), including egg protein, or after a previous dose of any influenza vaccine. Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (to include any systemic corticosteroids) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Participant plans to receive any licensed or authorized vaccine, including COVID-19 influenza vaccines, within 28 days before or after any study injection. Participant has received a NH 2021 - 2022 or 2022-2023 seasonal influenza vaccine or any other influenza vaccine, or an experimental RSV or cytomegalovirus (CMV) vaccine, within 6 months prior to study Day 1, and/or has not completed a primary vaccination series for COVID-19. Participant has received an authorized or approved COVID-19 vaccine within 4 months prior to Day 1, and/or has not completed a primary vaccination series for COVID-19. Participant had a laboratory-confirmed infection with influenza or RSV within 6 months prior to Day 1, or SARS-CoV-2 within 4 months of Day 1. SARS-CoV-2 infection confirmed with self-administered, authorized or approved rapid antigen test is acceptable. Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study. Participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study until 12 months after their last study vaccination. Other inclusion and exclusion criteria may apply.
Facility Information:
Facility Name
CenExel
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Meridian Clinical Research
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Facility Name
Johnson County Clinical Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Meridian Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Tekton Research, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
DM Clinical Research- Texas Center for Drug Development
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Modified mRNA Vaccines in Healthy Adults

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