A Study to Evaluate Self-Amplifying Ribonucleic Acid (RNA) Vaccine Preparations Against Influenza

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05227001

Collaborator

(none)

468

Enrollment

Locations

Arms

11.9

Anticipated Duration (Months)

19.5

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a dose-finding study to evaluate the safety, tolerability, and immunogenicity of self- amplifying ribonucleic acid (saRNA) vaccine preparations against influenza in healthy adults 18 through 49 years of age.

Participants will be randomized to receive either:

saRNA vaccine preparation,
licenced Quadrivalent Influenza Vaccine (QIV)
or placebo

Condition or Disease	Intervention/Treatment	Phase
Influenza, Human	Biological: PF-07852352 Influenza saRNA 1 Biological: PF-07836391 Influenza saRNA Biological: PF-07836394 Influenza saRNA Biological: PF-07836395 Influenza saRNA Biological: PF-07836396 Influenza saRNA Biological: PF-07867246 Influenza saRNA Biological: Placebo Biological: Quadrivalent influenza vaccine (QIV)	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

468 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Apr 28, 2022

Anticipated Primary Completion Date :

Apr 24, 2023

Anticipated Study Completion Date :

Apr 24, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-07852352 Influenza saRNA, low dose	Biological: PF-07852352 Influenza saRNA 1 Intramuscular injection
Experimental: PF-07852352 Influenza saRNA, mid dose	Biological: PF-07852352 Influenza saRNA 1 Intramuscular injection
Experimental: PF-07852352 Influenza saRNA, high dose	Biological: PF-07852352 Influenza saRNA 1 Intramuscular injection
Experimental: PF-07836391 Influenza saRNA, low dose	Biological: PF-07836391 Influenza saRNA Intramuscular injection
Experimental: PF-07836391 Influenza saRNA, mid dose	Biological: PF-07836391 Influenza saRNA Intramuscular injection
Experimental: PF-07836391 Influenza saRNA, high dose	Biological: PF-07836391 Influenza saRNA Intramuscular injection
Experimental: PF-07836394 Influenza saRNA, low dose	Biological: PF-07836394 Influenza saRNA Intramuscular injection
Experimental: PF-07836394 Influenza saRNA, mid dose	Biological: PF-07836394 Influenza saRNA Intramuscular injection
Experimental: PF-07836394 Influenza saRNA, high dose	Biological: PF-07836394 Influenza saRNA Intramuscular injection
Experimental: PF-07836395 Influenza saRNA, low dose	Biological: PF-07836395 Influenza saRNA Intramuscular injection
Experimental: PF-07836395 Influenza saRNA, mid dose	Biological: PF-07836395 Influenza saRNA Intramuscular injection
Experimental: PF-07836395 Influenza saRNA, high dose	Biological: PF-07836395 Influenza saRNA Intramuscular injection
Experimental: PF-07836396 Influenza saRNA, low dose	Biological: PF-07836396 Influenza saRNA Intramuscular injection
Experimental: PF-07836396 Influenza saRNA, mid dose	Biological: PF-07836396 Influenza saRNA Intramuscular injection
Experimental: PF-07836396 Influenza saRNA, high dose	Biological: PF-07836396 Influenza saRNA Intramuscular injection
Experimental: PF-07867246 Influenza saRNA, mid dose	Biological: PF-07867246 Influenza saRNA Intramuscular injection
Experimental: PF-07867246 Influenza saRNA, low dose	Biological: PF-07867246 Influenza saRNA Intramuscular injection
Experimental: PF-07867246 Influenza saRNA, high dose	Biological: PF-07867246 Influenza saRNA Intramuscular injection
Placebo Comparator: Placebo	Biological: Placebo Intramuscular injection
Active Comparator: Quadrivalent influenza vaccine (QIV)	Biological: Quadrivalent influenza vaccine (QIV) Intramuscular injection

Outcome Measures

Primary Outcome Measures

Percentage of participants reporting local reactions [For 10 days after vaccination]
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
Percentage of participants reporting systemic events [For 10 days after vaccination]
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries.
Percentage of participants reporting adverse events [From vaccination to 4 weeks after vaccination]
As elicited by investigational site staff.
Percentage of participants reporting serious adverse events [From vaccination to 6 months after vaccination]
As elicited by investigational site staff.
Percentage of participants with abnormal hematology and chemistry laboratory values [2 days after vaccination]
As measured at the central laboratory
Percentage of participants with abnormal hematology and chemistry laboratory values [1 week after vaccination]
As measured at the central laboratory
Percentage of participants with grading shifts in hematology and chemistry laboratory assessments [Between baseline and 2 days after vaccination]
As measured at the central laboratory.
Percentage of participants with grading shifts in hematology and chemistry laboratory assessments [Between baseline and 1 week after vaccination]
As measured at the central laboratory
Percentage of participants with new electrocardiogram (ECG) abnormalities [2 days after vaccination]
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
Percentage of participants with new ECG abnormalities [1 week after vaccination]
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist

Secondary Outcome Measures

Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers [At Baseline, and 1-, 2- and 4-weeks after vaccination]
As measured at the central laboratory
Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint [At Baseline, and 1-, 2- and 4-weeks after vaccination]
As measured at the central laboratory
Proportion of participants achieving HAI seroconversion for each strain [At 1-, 2-, and 4-weeks after vaccination]
As measured at the central laboratory
Proportion of participants with HAI titer >=1:40 for each strain [At Baseline, and 1-, 2-, and 4-weeks after vaccination]
As measured at the central laboratory

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Heart Rhythm Center	Phoenix	Arizona	United States	85016
2	Hope Research Institute	Phoenix	Arizona	United States	85018
3	The Pain Center of Arizona	Phoenix	Arizona	United States	85018
4	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
5	Finlay Medical Research	Greenacres City	Florida	United States	33467
6	Mount Sinai Hospital	Miami Beach	Florida	United States	33140
7	Panax Clinical Research	Miami Lakes	Florida	United States	33014
8	Advanced Pharma CR, LLC	Miami	Florida	United States	33147
9	Miami Clinical Research	Miami	Florida	United States	33155
10	Pines Care Research Center, LLC	Pembroke Pines	Florida	United States	33024
11	Pinnacle Health Care Center	Pembroke Pines	Florida	United States	33024
12	Comprehensive Cardiology Consultants	Pembroke Pines	Florida	United States	33028
13	Great Lakes Clinical Trials - Andersonville	Chicago	Illinois	United States	60640
14	Pioneer Heart Institute	Lincoln	Nebraska	United States	68506
15	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
16	NYU Langone Health	New York	New York	United States	10016
17	SUNY Upstate Medical University Global Health Laboratory	Syracuse	New York	United States	13210
18	SUNY Upstate Medical University	Syracuse	New York	United States	13215
19	Upstate University Hospital Community Campus	Syracuse	New York	United States	13215
20	CTI Clinical Research Center	Cincinnati	Ohio	United States	45212
21	Coastal Carolina Research Center	North Charleston	South Carolina	United States	29405
22	Benchmark Research	Austin	Texas	United States	78705
23	Eric S. Tiblier, MD	Austin	Texas	United States	78705
24	DM Clinical Research	Tomball	Texas	United States	77375