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

NCT05997290 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: C45910542024-000361-24NCT05997290
• Study Type: interventional
• Target: 1,051
• Locations: 1 country
• Sites: 37

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.

Conditions

SARS-CoV-2 Infection; COVID-19

Keywords

COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine; Vaccine-naïve

Outcome Measures

Primary Outcomes (30)

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA

  Local reactions: pain at injection site, redness and swelling were recorded by participants in an electronic diary (e-diary) or as adverse events (AEs) in the case report form (CRF). Redness and swelling were recorded in measuring device units (mdu) (range: 1 to 21), 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] and necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.

  Day 1 to Day 7 after vaccination

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA

  Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature more than or equal to (\>=38) degree Celsius (C) and categorized as \>= 38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous (IV) hydration. Diarrhea was graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.

  Day 1 to Day 7 after vaccination

• Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

  From vaccination on Day 1 up to 1 month after vaccination

• Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSA

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.

  From vaccination on Day 1 up to 6 months after vaccination

• Geometric Mean Titers (GMT) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044

  GMTs and 2-sided 95 percentage (%) confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ.

  At 1 month after vaccination

• GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044

  GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  At 1 month after vaccination

• Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Study Vaccination to 1 Month After Vaccination: SSA and Historical Control of Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044

  GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFR and 2-sided 95% CI were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  From before vaccination on Day 1 up to 1 month after vaccination

• GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044

  GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFR and 2-sided 95% CI were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  From before vaccination on Day 1 up to 1 month after vaccination

• Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044

  Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of \>= 4\* LLOQ was considered a seroresponse.

  At 1 month after vaccination

• Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044

  Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of \>= 4\* LLOQ was considered a seroresponse.

  At 1 month after vaccination

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB

  Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (\>2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] and necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.

  Day 1 to Day 7 after vaccination

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB

  Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature \>=38 degree C and categorized as \>= 38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: \>2 times in 24h, severe: required IV hydration. Diarrhea were graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.

  Day 1 to Day 7 after vaccination

• Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

  From vaccination on Day 1 up to 1 month after vaccination

• Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.

  From vaccination on Day 1 up to 6 months after vaccination

• Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5) COVID-19 Vaccine-Naive Participants in SSB Versus Vaccine-Experienced Participants in SSA

  GMTs / GMRs and 2-sided 95% CIs were calculated by exponentiating the least square (LS) means / difference of LS means and the corresponding CIs based on analysis of log-transformed assay results using a linear regression model with baseline assay results (log scale), age and vaccine group as covariates. Assay results below the LLOQ were set to 0.5\*LLOQ. GMT was reported in descriptive section and GMR was reported in statistical analysis section

  At 1 month after vaccination

• Percentage of Participants and Difference in Percentage of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5) COVID-19 Vaccine Naive Participants in SSB Versus Vaccine-Experienced Participants in SSA

  Seroresponse was defined as achieving \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of \>= 4\* LLOQ was considered a seroresponse. Percentage of participants with seroresponse were reported in descriptive section and difference in percentage of participants with seroresponse in SSB: All Age Groups (Vaccine Naive)- SSA: All Age Groups (Vaccine Experienced Control) were reported in statistical analysis section.

  At 1 month after vaccination

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined

  Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (\>2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] and necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.

  Day 1 to Day 7 after vaccination

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined

  Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature \>=38 degree C and categorized as \>= 38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: \>2 times in 24h, severe: required IV hydration. Diarrhea were graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.

  Day 1 to Day 7 after vaccination

• Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

  From vaccination on Day 1 up to 1 month after vaccination

• Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.

  From vaccination on Day 1 up to 6 months after vaccination

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 3

  Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (\>2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] and necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.

  Day 1 to Day 7 after vaccination

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3

  Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature \>=38 deg C and categorized as \>= 38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and joint pain: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: \>2 times in 24h, severe: required IV hydration. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 events were classified by investigator or medically qualified person.

  Day 1 to Day 7 after vaccination

• Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

  From vaccination on Day 1 up to 1 month after vaccination

• Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 3

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.

  From vaccination on Day 1 up to 6 months after vaccination

• GMTs of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA

  GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  At 1 month after vaccination

• GMFR of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA

  GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.

  From before Vaccination to 1 month after Vaccination

• Percentage of Participants With Seroresponse to SARS-CoV-2 OMI JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA

  Seroresponse was defined as achieving a \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result \>=4 \*LLOQ is considered a seroresponse.

  At 1 month after vaccination

• GMTs of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and SSC Cohorts 1 + 2 Combined as Control

  GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  At 1 month after vaccination

• GMFR of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined as Control

  GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.

  From before vaccination on Day 1 up to 1 month after vaccination

• Percentage of Participants With Seroresponse to SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined as Control

  Seroresponse was defined as achieving a \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result \>=4 \*LLOQ is considered a seroresponse.

  At 1 month after vaccination

Study Arms (5)

SSA: Group 1

EXPERIMENTAL

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)

SSB: Group 2

EXPERIMENTAL

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)

SSC: Group 3

EXPERIMENTAL

Cohort 1 - Participants 18 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1.

Biological: BNT162b2 (Omi JN.1)

SSC: Group 4

EXPERIMENTAL

Cohort 2 - Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1.

Biological: BNT162b2 (Omi JN.1)

SSC - Group 5

EXPERIMENTAL

Cohort 3 - Participants 18 years of age and older who will receive 30 µg of BNT162b2 (Omi KP.2) at Visit 1.

Biological: BNT162b2 (Omi KP.2)

Interventions

BNT162b2 (Omi XBB.1.5) BIOLOGICAL

BNT162b2 monovalent (Omicron XBB.1.5)

SSA: Group 1; SSB: Group 2

BNT162b2 (Omi JN.1) BIOLOGICAL

BNT162b2 monovalent (Omicron JN.1)

SSC: Group 3; SSC: Group 4

BNT162b2 (Omi KP.2) BIOLOGICAL

BNT162b2 monovalent (Omicron KP.2)

SSC - Group 5

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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
• COVID-19 vaccine-naïve.
• Any positive SARS-CoV-2 test result \>28 days before study intervention administration.
• years of age and older.
• Healthy participants (stable pre-existing disease permitted).

Sponsors & Collaborators

• BioNTech SE: lead
• Pfizer: collaborator

Study Sites (37)

North Alabama Research Center

Athens, Alabama, 35611, United States

Location

Medical Affiliated Research Center

Huntsville, Alabama, 35801, United States

Location

Alliance for Multispecialty Research, LLC

Mobile, Alabama, 36608, United States

Location

Epic Medical Research - Surprise

Surprise, Arizona, 85378, United States

Location

Alliance for Multispecialty Research, LLC

Tempe, Arizona, 85281, United States

Location

West Coast Research

Dublin, California, 94568, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Bayview Research Group, LLC

Valley Village, California, 91607, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

Care Research - West Flagler Street

Miami, Florida, 33130, United States

Location

Acevedo Clinical Research Associates

Miami, Florida, 33142, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States

Location

Bio-Kinetic Clinical Applications, LLC dba QPS-MO

Springfield, Missouri, 65802, United States

Location

Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)

Springfield, Missouri, 65807, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45409, United States

Location

Senders Pediatrics

South Euclid, Ohio, 44121, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37909, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, 38119, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Epic Medical Research - DeSoto

DeSoto, Texas, 75115, United States

Location

DM Clinical Research - Bellaire

Houston, Texas, 77081, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

IMA Clinical Research San Antonio

San Antonio, Texas, 78229, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Alliance for Multispecialty Research, LLC

Layton, Utah, 84041, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Alliance for Multispecialty Research, LLC

Norfolk, Virginia, 23502, United States

Location

Related Publications (4)

• Diya O, Gayed J, Lowry FS, Ma H, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Cutler M, Belanger T, Cooper D, Xu X, Mogg R, Tureci O, Sahin U, Swanson KA, Modjarrad K, Anderson AS, Gurtman A, Kitchin N. Safety and Immunogenicity of Monovalent Omicron KP.2-Adapted BNT162b2 COVID-19 Vaccine in Adults: Single-Arm Substudy from a Phase 2/3 Trial. Infect Dis Ther. 2025 Aug;14(8):1973-1987. doi: 10.1007/s40121-025-01185-4. Epub 2025 Jul 1.

  PMID: 40591130 DERIVED

• Diya O, Gayed J, Lowry FS, Ma H, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Cutler M, Belanger T, Cooper D, Xu X, Koury K, Tureci O, Sahin U, Swanson KA, Modjarrad K, Anderson AS, Gurtman A, Kitchin N. A phase 2/3 trial to investigate the safety and immunogenicity of monovalent Omicron JN.1-adapted BNT162b2 COVID-19 vaccine in adults >/=18 years old. Vaccine. 2025 Apr 11;52:126869. doi: 10.1016/j.vaccine.2025.126869. Epub 2025 Feb 24.

  PMID: 39999538 DERIVED

• Gayed J, Bangad V, Xu X, Mensa F, Cutler M, Tureci O, Sahin U, Modjarrad K, Swanson KA, Anderson AS, Gurtman A, Kitchin N; C4591054 Study Group. Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine against XBB.1.5, BA.2.86, and JN.1 Sublineages: A Phase 2/3 Trial. Vaccines (Basel). 2024 Jul 2;12(7):734. doi: 10.3390/vaccines12070734.

  PMID: 39066372 DERIVED

• Gayed J, Diya O, Lowry FS, Xu X, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Lu C, Cutler M, Belanger T, Cooper D, Koury K, Anderson AS, Tureci O, Sahin U, Swanson KA, Modjarrad K, Gurtman A, Kitchin N; C4591054 Study Group. Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals >/=12 Years Old: A Phase 2/3 Trial. Vaccines (Basel). 2024 Jan 24;12(2):118. doi: 10.3390/vaccines12020118.

  PMID: 38400102 DERIVED

Related Links

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

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: BioNTech SE
• Organization: BioNTech clinical trials patient information

patients@biontech.de

+496131 90840

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2/3, controlled study

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: August 10, 2023
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (37)