A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
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| ClinicalTrials.gov Identifier: NCT05596734 |
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Recruitment Status :
Recruiting
First Posted : October 27, 2022
Last Update Posted : April 21, 2023
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Sponsor:
BioNTech SE
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE
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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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | October 28, 2022 |
| Estimated Primary Completion Date : | December 13, 2024 |
| Estimated Study Completion Date : | December 13, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: qIRV + bivalent BNT162b2 (dose level combination 1)
Administered intramuscularly into the deltoid muscle of the right arm
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Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection Biological: qIRV (22/23) Intramuscular injection |
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Experimental: qIRV + bivalent BNT162b2 (dose level combination 2)
Administered intramuscularly into the deltoid muscle of the right arm
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Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection Biological: qIRV (22/23) Intramuscular injection |
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Experimental: qIRV + bivalent BNT162b2 (dose level combination 3)
Administered intramuscularly into the deltoid muscle of the right arm
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Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection Biological: qIRV (22/23) Intramuscular injection |
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Experimental: qIRV (dose level 1)
Administered intramuscularly into the deltoid muscle of the right arm
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Biological: qIRV (22/23)
Intramuscular injection |
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Experimental: qIRV (dose level 2)
Administered intramuscularly into the deltoid muscle of the right arm
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Biological: qIRV (22/23)
Intramuscular injection |
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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
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Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection Biological: QIV Intramuscular injection |
Primary Outcome Measures :
- Percentage of participants reporting local reactions [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: For 4 weeks after vaccination ]As elicited by investigational site staff.
- Percentage of participants reporting serious adverse events [ Time Frame: For 6 months after vaccination ]As elicited by investigational site staff.
- Percentage of participants with abnormal troponin I laboratory values [ Time Frame: 2 days after vaccination ]As measured at the central laboratory
- Percentage of participants with abnormal troponin I laboratory values [ Time Frame: 1 week after vaccination ]As measured at the central laboratory
- Percentage of participants with new electrocardiogram (ECG) abnormalities [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At baseline, and 1-, 4-, and 8-weeks after vaccination ]As measured at the central laboratory
- Geometric Mean Fold Rise (GMFRs) of HAI titers [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At 1-, 4-, 8-weeks after vaccination ]As measured at the central laboratory
- Percentage of participants with HAI ≥1:40 for all strains [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At 1-, 4-, and 8 weeks after vaccination. ]As measured at the central laboratory
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female participants 18 years of age and older
- 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.
- For participants 18 through 64 years of age: 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).
- For participants 65 years of age and older: participants who have received 4 or 5 prior doses of a modRNA SARS-CoV-2 vaccine, with the last dose being a bivalent vaccine, 120 days to 365 days before Visit 1 (Day 1).
- For Participants 65 years of age and older: receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season 120 days or more before study intervention administration.
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.
- For participants 18 through 64 years of age: 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05596734
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
Show 34 study locations
Sponsors and Collaborators
BioNTech SE
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | BioNTech SE |
| ClinicalTrials.gov Identifier: | NCT05596734 |
| Other Study ID Numbers: |
C5261001 |
| First Posted: | October 27, 2022 Key Record Dates |
| Last Update Posted: | April 21, 2023 |
| Last Verified: | April 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by BioNTech SE:
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SARS-Cov-2 COVID-19 Influenza Grippe |
Flu Vaccine RNA vaccine |
Additional relevant MeSH terms:
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COVID-19 Influenza, Human Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Orthomyxoviridae Infections |