Clinical trial NCT05972174: A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: Influenza vaccine
Moderna
mRNA-1018
Virus Diseases
Vaccines
Pandemic influenza
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 1504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 29 (7 days after each injection)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 43 (21 days after each injection)
measure: Number of Participants with AEs Leading to Discontinuation From Study
timeFrame: Day 1 to Day 205 (end of study [EoS])
measure: Number of Participants with Medically-Attended AEs (MAAEs)
timeFrame: Day 1 to Day 205 (EoS)
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Day 1 to Day 205 (EoS)
measure: Number of Participants with Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 to Day 205 (EoS)
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay
timeFrame: Days 22, 29, and 43
measure: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay
timeFrame: Baseline (Day 1), Days 22, 29, and 43
measure: Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay
timeFrame: Baseline (Day 1) to Days 22, 29, and 43
measure: Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43
timeFrame: Days 22, 29, and 43
measure: GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay
timeFrame: Days 22, 29, and 43
measure: GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay
timeFrame: Baseline (Day 1), Days 22, 29, and 43
measure: Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise
timeFrame: Baseline (Day 1) to Days 22, 29, and 43
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: CenExel RCA
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research
state: Georgia
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Southfield
country: United States
facility: DM Clinical Research
state: Michigan
city: Lincoln
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: East Greenwich
country: United States
facility: Velocity Clinical Research Providence
state: Rhode Island
city: Sugar Land
country: United States
facility: DM Clinical Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: South Jordan
country: United States
facility: J. Lewis Research, Inc/Jordan River Family Medicine
state: Utah
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
state: London
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
state: London
city: Bristol
country: United Kingdom
facility: University Hospitals
state: London
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University
state: London
city: Salford
country: United Kingdom
facility: Northern Care Alliance
state: London
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: London
city: Wrexham
country: United Kingdom
facility: North Wales Clinical Research Centre
state: London
city: Norwich
country: United Kingdom
facility: Quadram Institute NNUH CRF
state: Norfolk
city: Corby
country: United Kingdom
facility: Lakeside Healthcare Research Unit
state: Northamptonshire
city: Edinburgh
country: United Kingdom
facility: Western Hospital Edinburgh
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: St Georges Vaccine Institute Cranmer Terrace
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: North Finchley
country: United Kingdom
facility: Velocity Clinical Research
Study officials:
References: