Clinical trial NCT05227001: A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza
Official title: A PHASE 1, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF SELF-AMPLIFYING RNA VACCINE PREPARATIONS AGAINST INFLUENZA IN HEALTHY INDIVIDUALS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza, Human
Keywords: Grippe
Flu
Influenza
Vaccine
RNA vaccine
Self-amplifying
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who:

* Are between the age of 18 to 49 years old.
* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Are healthy as determined by medical history, physical examinations, and the study doctor.
* For male participants, can father children and willing to use an acceptable method of contraception. Female participants who are not of childbearing potential; or male participant not able to father children.
* Are capable of giving signed informed consent. Participants will receive either the saRNA vaccine, a licensed Influenza Vaccine (QIV) or a placebo. Participants will not know which vaccine they receive in advance. A placebo does not have any medicine in it but looks just like the study medicine. Participants will receive the study vaccines as a single shot in the arm. We will compare participant experiences to help us determine if the saRNA vaccine is safe and effective. Participants will take part in this study for 6 months. During this time, they will receive the study vaccine and participate in follow-up visits.


Eligibility criteria: Inclusion Criteria:

* Male or female participants 18 to 49 years of age.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
* Male participant who is able to father children and willing to use an acceptable method of contraception; or female participant not of childbearing potential; or male participant not able to father children.
* Capable of giving signed informed consent.

Exclusion Criteria:

* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
* Women who are pregnant or breastfeeding.
* Allergy to egg proteins (egg or egg products) or chicken proteins.
* Participant who has had significant exposure to laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection), coronavirus disease 2019 (COVID-19), or influenza in the past 14 days known prior to Visit 1
* Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to Visit 1 that has not been confirmed as negative.
* Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
* Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
* Vaccination with any influenza vaccine within 6 months (175 days) before study intervention administration.
* Any participant who has received or plans to receive a nucleoside-modified messenger ribonucleic acid (modRNA)-platform SARS-CoV-2 vaccine within 60 days of Visit 1
* Previous vaccination with an saRNA or an alphavirus replicon vaccine preparation.
* Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
* Screening hematology/blood chemistry lab \>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator.
* Screening electrocardiogram (ECG) that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or study results.
* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
* Participation in strenuous or endurance exercise through Visit 3.
* Prior history of heart disease.

Primary outcomes:
measure: Percentage of participants reporting local reactions
timeFrame: For 10 days after vaccination
measure: Percentage of participants reporting systemic events
timeFrame: For 10 days after vaccination
measure: Percentage of participants reporting adverse events
timeFrame: From vaccination to 4 weeks after vaccination
measure: Percentage of participants reporting serious adverse events
timeFrame: From vaccination to 6 months after vaccination
measure: Percentage of participants with abnormal hematology and chemistry laboratory values
timeFrame: 2 days after vaccination
measure: Percentage of participants with abnormal hematology and chemistry laboratory values
timeFrame: 1 week after vaccination
measure: Percentage of participants with grading shifts in hematology and chemistry laboratory assessments
timeFrame: Between baseline and 2 days after vaccination
measure: Percentage of participants with grading shifts in hematology and chemistry laboratory assessments
timeFrame: Between baseline and 1 week after vaccination
measure: Percentage of participants with new electrocardiogram (ECG) abnormalities
timeFrame: 2 days after vaccination
measure: Percentage of participants with new ECG abnormalities
timeFrame: 1 week after vaccination
Secondary outcomes:
measure: Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers
timeFrame: At Baseline, and 1-, 2- and 4-weeks after vaccination
measure: Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint
timeFrame: At Baseline, and 1-, 2- and 4-weeks after vaccination
measure: Proportion of participants achieving HAI seroconversion for each strain
timeFrame: At 1-, 2-, and 4-weeks after vaccination
measure: Proportion of participants with HAI titer >=1:40 for each strain
timeFrame: At Baseline, and 1-, 2-, and 4-weeks after vaccination
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Rhythm Center
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Greenacres City
country: United States
facility: Finlay Medical Research
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Hospital
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Pinnacle Health Care Center
state: Florida
city: Pembroke Pines
country: United States
facility: Comprehensive Cardiology Consultants
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Andersonville
state: Illinois
city: Lincoln
country: United States
facility: Pioneer Heart Institute
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Global Health Laboratory
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Institute for Global Health
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Eric S. Tiblier, MD
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: