Clinical trial NCT05397223: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: 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
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
timeFrame: Up to Day 176 (7 days follow-up post-vaccination)
measure: Number of Participants With Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 197 (28 days follow-up post-vaccination)
measure: Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination
timeFrame: Day 1 through end of study (EOS) (up to Day 1249)
measure: Number of Participants with Medically Attended Adverse Events (MAAEs)
timeFrame: Day 1 through Day 361
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
timeFrame: Days 1 (Baseline), 29, 85, and 197
measure: Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
timeFrame: Days 1 (Baseline), 29, 85, and 197
measure: Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647
timeFrame: Days 1 (Baseline), 29, 85, and 197
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: CenExel
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Sioux City
country: United States
facility: Meridian Clinical Research
state: Iowa
city: Lenexa
country: United States
facility: Johnson County Clinical Trials
state: Kansas
city: Lincoln
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc
state: Texas
city: Houston
country: United States
facility: DM Clinical Research- Texas Center for Drug Development
state: Texas
Study officials:
References: