A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults

Influenza Clinical Trial

Official title:

Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 Years of Age

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05972174
• Other study ID #: mRNA-1018-P101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 10, 2023
• Est. completion date: July 26, 2024

Study information

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

Clinical Trial Summary

The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1504
• Est. completion date: July 26, 2024
• Est. primary completion date: July 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and results of electrocardiogram testing.
• Body mass index of 18 kilograms (kg)/square meter (m^2) to 39 kg/m^2 (inclusive) at the Screening visit.
• For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding.

Key Exclusion Criteria:

• Participant is acutely ill or febrile (body temperature = 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
• History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
• Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
• Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to Screening Visit (for corticosteroids =10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
• Participant has received any vaccine authorized or approved by local health agency including mRNA vaccine =28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.
• Participant has 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/exclusion criteria may apply.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• mRNA-1018 for H5N8
Sterile liquid for injection
• mRNA-1018 for H7N9
Sterile liquid for injection
• mRNA-1018 for H5 Only
Sterile liquid for injection
• mRNA-1018 for H7 Only
Sterile liquid for injection
• mRNA-1018 for H5 Only-CG
Sterile liquid for injection

Locations

Country	Name	City	State
United States	J. Lewis Research, Inc/Jordan River Family Medicine	South Jordan	Utah

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 Adverse Reactions (ARs)		Up to Day 29 (7 days after each injection)
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 43 (21 days after each injection)
Primary	Number of Participants with AEs Leading to Discontinuation From Study		Day 1 to Day 205 (end of study [EoS])
Primary	Number of Participants with Medically-Attended AEs (MAAEs)		Day 1 to Day 205 (EoS)
Primary	Number of Participants with Serious Adverse Events (SAEs)		Day 1 to Day 205 (EoS)
Primary	Number of Participants with Adverse Events of Special Interest (AESIs)		Day 1 to Day 205 (EoS)
Secondary	Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay		Days 22, 29, and 43
Secondary	Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay		Baseline (Day 1), Days 22, 29, and 43
Secondary	Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay	Seroconversion is defined as a Day 22, 29, or 43 titer =1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is =1:10 in anti-HA antibodies measured by HAI assay.	Baseline (Day 1) to Days 22, 29, and 43
Secondary	Number of Participants With HAI Titer = 1:40 at Days 22, 29, and 43		Days 22, 29, and 43
Secondary	GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay		Days 22, 29, and 43
Secondary	GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay		Baseline (Day 1), Days 22, 29, and 43
Secondary	Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise	Number of participants with a change in the Days 22, 29, or 43 NAI titer of at least 2-/3-/4-fold rise, defined as =2-/3-/4-fold of the lower level of quantitation (LLOQ) if the Day 1 titer is	Baseline (Day 1) to Days 22, 29, and 43