A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05997290
• Other study ID #: C4591054
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: August 10, 2023
• Est. completion date: December 9, 2024

Study information

• Verified date: March 2024
• Source: BioNTech SE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 730
• Est. completion date: December 9, 2024
• Est. primary completion date: December 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Biological:
• BNT162b2 (Omi XBB.1.5)
BNT162b2 monovalent (Omicron XBB.1.5)

Locations

Country	Name	City	State
United States	North Alabama Research Center	Athens	Alabama
United States	Elligo Clinical Research Center	Austin	Texas
United States	Kentucky Pediatric/ Adult Research	Bardstown	Kentucky
United States	Epic Medical Research-Oklahoma	Chickasha	Oklahoma
United States	Centricity Research Columbus Ohio Multispecialty	Columbus	Ohio
United States	Zenos Clinical Research	Dallas	Texas
United States	Dayton Clinical Research	Dayton	Ohio
United States	Epic Medical Research - DeSoto	DeSoto	Texas
United States	West Coast Research	Dublin	California
United States	Ascension St. John Hospital	Grosse Pointe Woods	Michigan
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	DM Clinical Research - Bellaire	Houston	Texas
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Jacksonville	Florida
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Alliance for Multispecialty Research, LLC	Layton	Utah
United States	Alliance for Multispecialty Research, LLC	Lexington	Kentucky
United States	Clinical Neuroscience Solutions Inc.	Memphis	Tennessee
United States	SMS Clinical Research	Mesquite	Texas
United States	Acevedo Clinical Research Associates	Miami	Florida
United States	Care Research - West Flagler Street	Miami	Florida
United States	Clinical Research Consulting	Milford	Connecticut
United States	Alliance for Multispecialty Research, LLC	Mobile	Alabama
United States	Alliance for Multispecialty Research, LLC	Norfolk	Virginia
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah
United States	IMA Clinical Research San Antonio	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	Senders Pediatrics	South Euclid	Ohio
United States	Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)	Springfield	Missouri
United States	Bio-Kinetic Clinical Applications, LLC dba QPS-MO	Springfield	Missouri
United States	Bio-Kinetic Clinical Applications, LLD dba QPS-MO	Springfield	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Epic Medical Research - Surprise	Surprise	Arizona
United States	Alliance for Multispecialty Research, LLC	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Bayview Research Group, LLC	Valley Village	California
United States	Diablo Clinical Research, Inc.	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
BioNTech SE	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSA: Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.	For up to 7 days following the study vaccination
Primary	SSA: 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 up to 7 days following the study vaccination
Primary	SSA: Percentage of participants reporting adverse events	As elicited by the investigational staff	Through 1 month after the study vaccination
Primary	SSA: Percentage of participants reporting serious adverse events	As elicited by the investigational staff	Through 6 months after the study vaccination
Primary	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	As measured at the central laboratory	At 1 month after the study vaccination
Primary	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	As measured at the central laboratory	From before study vaccination (Day 1) to 1 month after study vaccination
Primary	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	As measured at the central laboratory	At 1 month after the study vaccination
Primary	SSB: Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.	For up to 7 days following the study vaccination
Primary	SSB: 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 up to 7 days following the study vaccination
Primary	SSB: Percentage of participants reporting adverse events	As elicited by the investigational staff.	Through 1 month after the study vaccination
Primary	SSB: Percentage of participants reporting serious adverse events	As elicited by the investigational staff.	Through 6 months after the study vaccination
Primary	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.	As measured at the central laboratory	At 1 month after vaccination.
Primary	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	As measured at the central laboratory	At 1 month after vaccination

External Links

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