A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227001
• Other study ID #: C4861001
• Status: Completed
• Phase: Phase 1
• Start date: April 28, 2022
• Est. completion date: August 4, 2023

Study information

• Verified date: September 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: August 4, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• PF-07852352 Influenza saRNA 1
Intramuscular injection
• PF-07836391 Influenza saRNA
Intramuscular injection
• PF-07836394 Influenza saRNA
Intramuscular injection
• PF-07836395 Influenza saRNA
Intramuscular injection
• PF-07836396 Influenza saRNA
Intramuscular injection
• PF-07867246 Influenza saRNA
Intramuscular injection
• Placebo
Intramuscular injection
• Quadrivalent influenza vaccine (QIV)
Intramuscular injection
• PF-07871987 Influenza saRNA
Intramuscular injection
• PF-07914705 Influenza saRNA
Intramuscular injection
• PF-07915048 Influenza saRNA
Intramuscular injection

Locations

Country	Name	City	State
United States	Benchmark Research	Austin	Texas
United States	Eric S. Tiblier, MD	Austin	Texas
United States	Great Lakes Clinical Trials - Andersonville	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Finlay Medical Research	Greenacres City	Florida
United States	Pioneer Heart Institute	Lincoln	Nebraska
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Miami Clinical Research	Miami	Florida
United States	Mount Sinai Hospital	Miami Beach	Florida
United States	Panax Clinical Research	Miami Lakes	Florida
United States	NYU Langone Health	New York	New York
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Velocity Clinical Research, Omaha	Omaha	Nebraska
United States	Comprehensive Cardiology Consultants	Pembroke Pines	Florida
United States	Pines Care Research Center, LLC	Pembroke Pines	Florida
United States	Pinnacle Health Care Center	Pembroke Pines	Florida
United States	Arizona Heart Rhythm Center	Phoenix	Arizona
United States	Hope Research Institute	Phoenix	Arizona
United States	The Pain Center of Arizona	Phoenix	Arizona
United States	SUNY Upstate Medical University	Syracuse	New York
United States	SUNY Upstate Medical University Global Health Laboratory	Syracuse	New York
United States	SUNY Upstate Medical University Institute for Global Health	Syracuse	New York
United States	DM Clinical Research	Tomball	Texas
United States	Diablo Clinical Research, Inc.	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.	For 10 days after vaccination
Primary	Percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries.	For 10 days after vaccination
Primary	Percentage of participants reporting adverse events	As elicited by investigational site staff.	From vaccination to 4 weeks after vaccination
Primary	Percentage of participants reporting serious adverse events	As elicited by investigational site staff.	From vaccination to 6 months after vaccination
Primary	Percentage of participants with abnormal hematology and chemistry laboratory values	As measured at the central laboratory	2 days after vaccination
Primary	Percentage of participants with abnormal hematology and chemistry laboratory values	As measured at the central laboratory	1 week after vaccination
Primary	Percentage of participants with grading shifts in hematology and chemistry laboratory assessments	As measured at the central laboratory.	Between baseline and 2 days after vaccination
Primary	Percentage of participants with grading shifts in hematology and chemistry laboratory assessments	As measured at the central laboratory	Between baseline and 1 week after vaccination
Primary	Percentage of participants with new electrocardiogram (ECG) abnormalities	ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist	2 days after vaccination
Primary	Percentage of participants with new ECG abnormalities	ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist	1 week after vaccination
Secondary	Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers	As measured at the central laboratory	At Baseline, and 1-, 2- and 4-weeks after vaccination
Secondary	Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint	As measured at the central laboratory	At Baseline, and 1-, 2- and 4-weeks after vaccination
Secondary	Proportion of participants achieving HAI seroconversion for each strain	As measured at the central laboratory	At 1-, 2-, and 4-weeks after vaccination
Secondary	Proportion of participants with HAI titer >=1:40 for each strain	As measured at the central laboratory	At Baseline, and 1-, 2-, and 4-weeks after vaccination

External Links

•   To obtain contact information for a study center near you, click here.