A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza

Sponsor

BioNTech SE (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05596734

Collaborator

Pfizer (Industry)

180

Enrollment

Locations

Arms

19.2

Anticipated Duration (Months)

9.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either:

qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations
qIRV (22/23) at dose level 1,
qIRV (22/23) at dose level 2, or
bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV).

Condition or Disease	Intervention/Treatment	Phase
Influenza, Human COVID-19	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5) Biological: qIRV (22/23) Biological: QIV	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A PHASE 1 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS

Actual Study Start Date :

Oct 28, 2022

Anticipated Primary Completion Date :

Jun 4, 2024

Anticipated Study Completion Date :

Jun 4, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: qIRV + bivalent BNT162b2 (dose level combination 1) Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5) Intramuscular injection Biological: qIRV (22/23) Intramuscular injection
Experimental: qIRV + bivalent BNT162b2 (dose level combination 2) Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5) Intramuscular injection Biological: qIRV (22/23) Intramuscular injection
Experimental: qIRV + bivalent BNT162b2 (dose level combination 3) Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5) Intramuscular injection Biological: qIRV (22/23) Intramuscular injection
Experimental: qIRV (dose level 1) Administered intramuscularly into the deltoid muscle of the right arm	Biological: qIRV (22/23) Intramuscular injection
Experimental: qIRV (dose level 2) Administered intramuscularly into the deltoid muscle of the right arm	Biological: qIRV (22/23) Intramuscular injection
Experimental: bivalent BNT162b2 (dose level 1) + QIV BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5) Intramuscular injection Biological: QIV Intramuscular injection

Outcome Measures

Primary Outcome Measures

Percentage of participants reporting local reactions [For 7 days after vaccination]
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
Percentage of participants reporting systemic events [For 7 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 [For 4 weeks after vaccination]
As elicited by investigational site staff.
Percentage of participants reporting serious adverse events [For 6 months after vaccination]
As elicited by investigational site staff.
Percentage of participants with abnormal troponin I laboratory values [2 days after vaccination]
As measured at the central laboratory
Percentage of participants with abnormal troponin I laboratory values [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-, 4-, and 8-weeks after vaccination]
As measured at the central laboratory
Geometric Mean Fold Rise (GMFRs) of HAI titers [At baseline, and 1-, 4-, and 8-weeks after vaccination]
As measured at the central laboratory
Proportion of participants achieving HAI seroconversion for each strain [At 1-, 4-, and 8-weeks after vaccination]
As measured at the central laboratory
Percentage of participants with HAI titers ≥ 1:40 for each strain [Before vaccination and at 1-, 4-, 8-weeks after vaccination]
As measured at the central laboratory
Percentage of participants achieving HAI seroconversion for all strains [At 1-, 4-, 8-weeks after vaccination]
As measured at the central laboratory
Percentage of participants with HAI ≥1:40 for all strains [At 1-, 4-, 8-weeks after vaccination]
As measured at the central laboratory
GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers [At 1-, 4-, and 8 weeks after vaccination]
As measured at the central laboratory
GMFRs of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers [At 1-, 4-, and 8 weeks after vaccination]
As measured at the central laboratory
Percentage of participants with seroresponse based on SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers [At 1-, 4-, and 8 weeks after vaccination.]
As measured at the central laboratory

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female participants 18 through 64 years of age
Participants who are willing and able to comply with all scheduled visits, investigational 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.
Capable of giving signed informed consent as described in the protocol.
Participants who have received 3 prior doses of 30 µg BNT162b2, with the last dose being 150 to 365 days before Visit 1 (Day 1).

Exclusion Criteria:

History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Immunocompromised individuals with known or suspected immunodeficiency.
Bleeding diathesis or condition associated with prolonged bleeding.
Women who are pregnant or breastfeeding.
Allergy to egg proteins (egg or egg products) or chicken proteins.
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.
Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of 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 investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration.
Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Participation in strenuous or endurance exercise through Visit 3 of the study.
Prior history of heart disease.
Any abnormal screening troponin I laboratory value.
Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Alabama Research Center	Athens	Alabama	United States	35611
2	The Heart Center	Athens	Alabama	United States	35611
3	Orange County Heart Institute	Orange	California	United States	92868
4	Orange County Research Center	Tustin	California	United States	92780
5	Proactive Clinical Research,LLC	Fort Lauderdale	Florida	United States	33308
6	Research Centers of America ( Hollywood )	Hollywood	Florida	United States	33024
7	Gerardo Polanco, MD	Miami	Florida	United States	33156
8	Research Institute of South Florida	Miami	Florida	United States	33173
9	Entrust Clinical Research	Miami	Florida	United States	33176
10	Miami Dade Medical Research Institute, LLC	Miami	Florida	United States	33176
11	DBC Research USA	Pembroke Pines	Florida	United States	33029
12	United Medical Research	Port Orange	Florida	United States	32127
13	Meridian Clinical Research, LLC	Savannah	Georgia	United States	31406
14	Savannah Medical Group	Savannah	Georgia	United States	31419
15	Monroe Biomedical Research	Monroe	North Carolina	United States	28112
16	M3 Wake Research, Inc.	Raleigh	North Carolina	United States	27612
17	Main Street Physician's Care	Little River	South Carolina	United States	29566
18	McLeod Cardiology Associates - Little River	Little River	South Carolina	United States	29566
19	Prolato Clinical Research Center	Houston	Texas	United States	77054