Clinical trial NCT05997290: A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: SARS-CoV-2 Infection
COVID-19
Keywords: COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Vaccine-naïve
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2023-08-18
Enrollment: 1051
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 2/3, controlled study
Primary purpose: PREVENTION

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.

Substudy C:

* This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to:

  * Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and,
  * Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and,
  * Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2).
  * Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose 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 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic.
* At each clinic visit a blood sample will be taken.
* At least 1 nasal swab will taken.


Eligibility 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.

SSC

Inclusion Criteria:

* Cohort 1: 18 years of age and older
* Cohort 2: 12 years of age and older
* Cohort 3: 18 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.
* Receipt of a COVID-19 vaccine less than 150 days before study intervention administration Visit 1 (Day 1).
* 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.

Primary outcomes:
measure: SSA: Percentage of participants reporting local reactions
timeFrame: For up to 7 days following the study vaccination
measure: SSA: Percentage of participants reporting systemic events
timeFrame: For up to 7 days following the study vaccination
measure: SSA: Percentage of participants reporting adverse events
timeFrame: Through 1 month after the study vaccination
measure: SSA: Percentage of participants reporting serious adverse events
timeFrame: Through 6 months after the study vaccination
measure: 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
timeFrame: At 1 month after the study vaccination
measure: 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
timeFrame: From before study vaccination (Day 1) to 1 month after study vaccination
measure: 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
timeFrame: At 1 month after the study vaccination
measure: SSB: Percentage of participants reporting local reactions
timeFrame: For up to 7 days following the study vaccination
measure: SSB: Percentage of participants reporting systemic events
timeFrame: For up to 7 days following the study vaccination
measure: SSB: Percentage of participants reporting adverse events
timeFrame: Through 1 month after the study vaccination
measure: SSB: Percentage of participants reporting serious adverse events
timeFrame: Through 6 months after the study vaccination
measure: 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.
timeFrame: At 1 month after vaccination.
measure: 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
timeFrame: At 1 month after vaccination
measure: SSC Cohort 1 and Cohort 2 combined: Percentage of participants reporting local reactions
timeFrame: For up to 7 days following the study vaccination
measure: SSC Cohort 1 and Cohort 2 combined: Percentage of participants reporting systemic events
timeFrame: For up to 7 days following the study vaccination
measure: SSC Cohort 1 and Cohort 2 combined: Percentage of participants reporting adverse events
timeFrame: Through 1 month after the study vaccination
measure: SSC Cohort 1 and Cohort 2 combined: Percentage of participants reporting serious adverse events
timeFrame: Through 6 months after the study vaccination
measure: SSC Cohort 1 and Cohort 2 combined: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron JN.1- and Omicron XBB.1.5- neutralizing antibody levels for BNT162b2 (Omi JN.1) 30 µg.
timeFrame: At 1 month after the study vaccination
measure: SSC Cohort 1 and Cohort 2 combined: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron JN.1- and Omicron XBB.1.5- neutralizing antibody levels for BNT162b2 (Omi JN.1) 30 µg.
timeFrame: From before study vaccination (Day 1) to 1 month after study vaccination
measure: SSC Cohort 1 and Cohort 2 combined: Percentages of participants with seroresponse to BNT162b2 (Omi JN.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron JN.1- and Omicron XBB.1.5-neutralizing antibody levels.
timeFrame: At 1 month after the study vaccination
measure: SSC Cohort 3: Percentage of participants reporting local reactions
timeFrame: For up to 7 days following the study vaccination
measure: SSC Cohort 3: Percentage of participants reporting systemic events
timeFrame: For up to 7 days following the study vaccination
measure: SSC Cohort 3: Percentage of participants reporting adverse events
timeFrame: Through 1 month after the study vaccination
measure: SSC Cohort 3: Percentage of participants reporting serious adverse events
timeFrame: Through 6 months after the study vaccination
measure: SSC Cohort 3: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron KP.2- and Omicron JN.1- neutralizing antibody levels for BNT162b2 (Omi KP.2) 30 µg.
timeFrame: At 1 month after the study vaccination
measure: SSC Cohort 3: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron KP.2- and Omicron JN.1- neutralizing antibody levels for BNT162b2 (Omi KP.2) 30 µg.
timeFrame: From before study vaccination (Day 1) to 1 month after study vaccination
measure: SSC Cohort 3: Percentages of participants with seroresponse to BNT162b2 (Omi KP.2) 30 µg in terms of GMTs of SARS-CoV-2 Omicron KP.2- and Omicron JN.1- neutralizing antibody levels.
timeFrame: At 1 month after the study vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Surprise
country: United States
facility: Epic Medical Research - Surprise
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Arizona
city: Dublin
country: United States
facility: West Coast Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Valley Village
country: United States
facility: Bayview Research Group, LLC
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Miami
country: United States
facility: Care Research - West Flagler Street
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Bardstown
country: United States
facility: Kentucky Pediatric/ Adult Research
state: Kentucky
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC dba QPS-MO
state: Missouri
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)
state: Missouri
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research - DeSoto
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Bellaire
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: