A Study of Modified mRNA Vaccines in Healthy Adults

SARS-CoV-2 Clinical Trial

Official title:

Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Modified mRNA Vaccines Using a Systems Biology Approach in Healthy Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05397223
• Other study ID #: mRNA-CRID-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 24, 2022
• Est. completion date: February 21, 2026

Study information

• Verified date: March 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 308
• Est. completion date: February 21, 2026
• Est. primary completion date: February 21, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cytomegalovirus
• Influenza, Human
• Respiratory Syncytial Virus
• SARS-CoV-2
• Seasonal Influenza

Intervention

Biological:
• mRNA-1273
Sterile liquid for injection
• mRNA-1010
Sterile liquid for injection
• mRNA-1345
Sterile liquid for injection
• FLUAD®
adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine
• mRNA-1647
Sterile lyophilized product

Locations

Country	Name	City	State
United States	Benchmark Research	Austin	Texas
United States	Tekton Research, Inc	Austin	Texas
United States	CenExel	Hollywood	Florida
United States	DM Clinical Research- Texas Center for Drug Development	Houston	Texas
United States	Johnson County Clinical Trials	Lenexa	Kansas
United States	Meridian Clinical Research	Lincoln	Nebraska
United States	Meridian Clinical Research	Savannah	Georgia
United States	Meridian Clinical Research	Sioux City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)		Up to Day 176 (7 days follow-up post-vaccination)
Primary	Number of Participants With Unsolicited Adverse Events (AEs)		Up to Day 197 (28 days follow-up post-vaccination)
Primary	Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination		Day 1 through end of study (EOS) (up to Day 1249)
Primary	Number of Participants with Medically Attended Adverse Events (MAAEs)		Day 1 through Day 361
Secondary	Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345		Days 1 (Baseline), 29, 85, and 197
Secondary	Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345		Days 1 (Baseline), 29, 85, and 197
Secondary	Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647		Days 1 (Baseline), 29, 85, and 197