A Study of Modified mRNA Vaccines in Healthy Adults

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05397223

Collaborator

(none)

300

Enrollment

Locations

Arms

18.2

Anticipated Duration (Months)

37.5

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Seasonal Influenza Respiratory Syncytial Virus Cytomegalovirus	Biological: mRNA-1273 Biological: mRNA-1010 Biological: mRNA-1345 Biological: FLUAD® Biological: mRNA-1647	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 24, 2022

Anticipated Primary Completion Date :

Aug 22, 2022

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: mRNA-1345 Participants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.	Biological: mRNA-1345 Sterile liquid for injection
Experimental: Part 1: mRNA-1647 2-Dose Participants will receive single IM injection of mRNA-1647 on Days 1 and 57.	Biological: mRNA-1647 Sterile lyophilized product
Experimental: Part 1: mRNA-1647 3-Dose Participants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.	Biological: mRNA-1647 Sterile lyophilized product
Experimental: Part 2: mRNA-1273 Participants will receive single IM injection of mRNA-1273 on Day 1	Biological: mRNA-1273 Sterile liquid for injection
Experimental: Part 2: mRNA-1010 Participants will receive single IM injection of mRNA-1010 on Day 1.	Biological: mRNA-1010 Sterile liquid for injection
Active Comparator: Part 2: FLUAD® Participants will receive single IM injection of FLUAD® on Day 1.	Biological: FLUAD® adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine

Outcome Measures

Primary Outcome Measures

Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [Up to Day 176 (7 days follow-up post-vaccination)]
Number of Participants With Unsolicited Adverse Events (AEs) [Up to Day 197 (28 days follow-up post-vaccination)]
Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), Medically-Attended Adverse Events (MAAEs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination [Day 1 through end of study (EOS) (up to Day 529)]

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 [Day 1 (Baseline), Day 29]
Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345 [Day 1 (Baseline), Day 29]
Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345 [Day 1 (Baseline), Day 29]
GMT of Serum Neutralizing Antibody Response for mRNA-1647 [Days 1 (Baseline), 29, 85, and 197]
GMFR of Serum Neutralizing Antibody Response for mRNA-1647 [Days 1 (Baseline), 29, 85, and 197]
Percentage of Participants With Seroresponse for mRNA-1647 [Days 1 (Baseline), 29, 85, and 197]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CenExel	Hollywood	Florida	United States	33024
2	Meridian Clinical Research	Savannah	Georgia	United States	31406
3	Johnson County Clinical Trials	Lenexa	Kansas	United States	66219
4	Sundance Clinical Research LLC	Saint Louis	Missouri	United States	63141
5	Meridian Clinical Research	Binghamton	New York	United States	13901
6	Meridian Clinical Research	Endwell	New York	United States	13760
7	Tekton Research, Inc	Austin	Texas	United States	78745
8	Benchmark Research	Fort Worth	Texas	United States	76135