A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05997290 |
|
Recruitment Status :
Active, not recruiting
First Posted : August 18, 2023
Last Update Posted : March 15, 2024
|
Sponsor:
BioNTech SE
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.
Substudy A:
-
This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,
- in people who are 12 years of age and older,
- who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1).
- The study is about 6 months long for each participant.
- Participants will have at least 5 visits to the clinic.
- At each clinic visit a blood sample will be taken.
- At least 1 nasal swab will taken.
Substudy B:
-
This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,
- in people who are 12 years of age and older,
- who are COVID-19 vaccine-naïve
- who have had any positive SARS-CoV-2 test result >28 days before study vaccine administration.
- The study is about 6 months long for each participant.
- Participants will have at least 5 visits to the clinic.
- At each clinic visit a blood sample will be taken.
- At least 1 nasal swab will taken.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| SARS-CoV-2 Infection COVID-19 | Biological: BNT162b2 (Omi XBB.1.5) | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 730 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Phase 2/3, controlled study |
| Masking: | None (Open Label) |
| Masking Description: | Open-label |
| Primary Purpose: | Prevention |
| Official Title: | A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALS |
| Actual Study Start Date : | August 10, 2023 |
| Estimated Primary Completion Date : | December 9, 2024 |
| Estimated Study Completion Date : | December 9, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: SSA: Group 1
Participants 12 years of age and older, COVID-19 vaccine-experienced will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.
|
Biological: BNT162b2 (Omi XBB.1.5)
BNT162b2 monovalent (Omicron XBB.1.5) |
|
Experimental: SSB: Group 2
Participants 12 years of age and older who were previously exposed to SARS-CoV-2 and are COVID-19 vaccine-naïve will receive 30 μg of BNT162b2 (Omi XBB.1.5) at Visit 1
|
Biological: BNT162b2 (Omi XBB.1.5)
BNT162b2 monovalent (Omicron XBB.1.5) |
Primary Outcome Measures :
- SSA: Percentage of participants reporting local reactions [ Time Frame: For up to 7 days following the study vaccination ]Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
- SSA: Percentage of participants reporting systemic events [ Time Frame: For up to 7 days following the study vaccination ]Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
- SSA: Percentage of participants reporting adverse events [ Time Frame: Through 1 month after the study vaccination ]As elicited by the investigational staff
- SSA: Percentage of participants reporting serious adverse events [ Time Frame: Through 6 months after the study vaccination ]As elicited by the investigational staff
- SSA: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg [ Time Frame: At 1 month after the study vaccination ]As measured at the central laboratory
- SSA: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron XBB.1.5-and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg [ Time Frame: From before study vaccination (Day 1) to 1 month after study vaccination ]As measured at the central laboratory
- SSA: Percentages of participants with seroresponse to BNT162b2 (Omi XBB.1.5) 30 µg in terms of GMTs of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels [ Time Frame: At 1 month after the study vaccination ]As measured at the central laboratory
- SSB: Percentage of participants reporting local reactions [ Time Frame: For up to 7 days following the study vaccination ]Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
- SSB: Percentage of participants reporting systemic events [ Time Frame: For up to 7 days following the study vaccination ]Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries.
- SSB: Percentage of participants reporting adverse events [ Time Frame: Through 1 month after the study vaccination ]As elicited by the investigational staff.
- SSB: Percentage of participants reporting serious adverse events [ Time Frame: Through 6 months after the study vaccination ]As elicited by the investigational staff.
- SSB: Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-neutralizing titers after BNT162b2 (Omi XBB.1.5) 30 μg given as single dose to COVID-19 vaccine-naïve subjects to BNT162b2 (Omi XBB.1.5) 30 μg given to vaccine-experienced participants in SSA. [ Time Frame: At 1 month after vaccination. ]As measured at the central laboratory
- Difference in percentages of subjects with seroresponse to XBB.1.5 strain after BNT162b2 (Omi XBB.1.5) 30 μg given as single dose to COVID-19 vaccine-naïve subjects compared to BNT162b2 (Omi XBB.1.5) 30 μg given to vaccine experienced subjects in SSA [ Time Frame: At 1 month after vaccination ]As measured at the central laboratory
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
SSA
Inclusion Criteria:
- Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before Visit 1 (Day 1).
- 12 years of age and older
- Healthy participants (stable pre-existing disease permitted).
- Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
- Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent.
Exclusion Criteria
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
- Immunocompromised 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.
- Any medical or psychiatric condition, 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 myocarditis or pericarditis.
- Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.
- Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of 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.
SSB
Inclusion Criteria:
- COVID-19 vaccine-naïve.
- Any positive SARS-CoV-2 test result >28 days before study intervention administration.
- 12 years of age and older.
- Healthy participants (stable pre-existing disease permitted).
- Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
- Capable of giving or parent(s)/legal guardian capable of giving, signed informed consent.
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
- 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.
- Any 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 myocarditis or pericarditis.
- Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids*, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study intervention administration or planned receipt throughout the study.
- Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of 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.
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): NCT05997290
Locations
Show 42 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: | NCT05997290 |
| Other Study ID Numbers: |
C4591054 |
| First Posted: | August 18, 2023 Key Record Dates |
| Last Update Posted: | March 15, 2024 |
| Last Verified: | March 2024 |
| 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:
|
COVID-19 Coronavirus Vaccine |
SARS-CoV-2 RNA Vaccine Vaccine-naïve |
Additional relevant MeSH terms:
|
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |