The primary objective of the study is to determine the relative efficacy of the investigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine tablet VXA-CoV2-3.3 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19). In order to represent a more recently circulating SARS-CoV-2 variant, the main study endpoints will now evaluate the VXA-CoV2-3.3 (KP.2 strain) vaccine, and not the VXA-CoV2-3.1 (XBB.1.5 strain) vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
5,485
Tablets for oral use.
Intramuscular (IM) injection.
Tablets for oral use.
Pinnacle Research Group
Anniston, Alabama, United States
Core Clinical Trials - Central Alabama Research LLC
Birmingham, Alabama, United States
Coastal Clinical Research
Mobile, Alabama, United States
Avacare - Lenzmeier Family Medicine
Glendale, Arizona, United States
Desert Clinical Research
Mesa, Arizona, United States
KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic Polymerase Chain Reaction (PCR)-Positive COVID-19 at 14 Days Post-vaccination
Time frame: Up to approximately Day 14
KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 at 12 Months Post-vaccination
Time frame: Up to approximately 12 months
XBB Sentinel Cohorts: Percentage of Participants who Experience any Solicited Local Reactogenicity Through 7 Days Post-vaccination
Time frame: Up to approximately Day 7
XBB Sentinel Cohorts: Percentage of Participants who Experience any Solicited Systemic Reactogenicity Through 7 Days Post-vaccination
Time frame: Up to approximately Day 7
XBB Sentinel Cohorts: Percentage of Participants who Experience Unsolicited Adverse Events (AEs) Through 30 Days Post-vaccination
Time frame: Up to approximately Day 30
XBB Sentinel Cohorts: Percentage of Participants who Experience Treatment-emergent Adverse Events (TEAEs) Through 12 Months Post-vaccination
An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. An AE of special interest (AESI) is an AE (serious or non-serious) of scientific and medical concern specific to the sponsor's product or program. Medically attended AEs (MAAEs) are defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic. A serious TEAE (SAE) is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Time frame: Up to approximately 12 months
XBB Sentinel Cohorts: Percentage of Participants With any Clinically Significant Abnormal Safety Laboratory Results Within 7 Days Pots-vaccination
Time frame: Up to approximately Day 7
KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 Within 14 Days and 12 Months Post-vaccination in Participants with Specified Body Mass Index (BMI)
Time frame: Up to approximately 12 months
KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 within 0 and 180 Days Post-vaccination
Time frame: Up to approximately 180 days
KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 within 181 and 365 Days Post-vaccination
Time frame: Up to approximately 365 days
KP.2 Cohorts: Number of Participants with First Occurrence of Confirmed Asymptomatic PCR-Positive COVID-19 within 14 Days and 12 Months Post-vaccination from Self-administered at Home Tests
Time frame: Up to approximately 12 months
KP.2 Cohorts: Number of Participants with First Occurrence of Presumptive Asymptomatic PCR-Positive COVID-19 from Self-administered at Home Tests
Time frame: Up to approximately 12 months
KP.2 Cohorts: Number of Participants with First Occurrence of Severe PCR-Positive COVID-19 within 14 Days and 12 Months Post-vaccination
Time frame: Up to approximately 12 months
KP.2 Cohorts: Percentage of Participants who Experience any Solicited Local Reactogenicity Through 7 Days Post-vaccination
Time frame: Up to approximately Day 7
KP.2 Cohorts: Percentage of Participants who Experience any Solicited Systemic Reactogenicity Through 7 Days Post-vaccination
Time frame: Up to approximately Day 7
KP.2 Cohorts: Percentage of Participants who Experience Unsolicited AEs Through 30 Days Post-vaccination
Time frame: Up to approximately Day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Velocity Clinical Research - MedPharmics - Phoenix
Phoenix, Arizona, United States
Foothills Research Center
Phoenix, Arizona, United States
Avacare (CCT) - Fiel Family & Sports Medicine
Tempe, Arizona, United States
Baptist Health Center for Clinical Research - Little Rock
Little Rock, Arkansas, United States
Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group
Cerritos, California, United States
...and 135 more locations
KP.2 Cohorts: Percentage of Participants who Experience TEAEs Through 12 Months Post-vaccination
An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. An AESI is an AE (serious or non-serious) of scientific and medical concern specific to the sponsor's product or program. MAAEs are defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic. An SAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Time frame: Up to approximately 12 months
KP.2 Cohorts: Percentage of Participants With any Clinically Significant Abnormal Safety Laboratory Results Within 7 Days Pots-vaccination
Time frame: Up to approximately Day 7
KP.2 Cohorts: Geometric Mean titer (GMT) of SARS-CoV-2 Specific Serum Neutralizing Antibodies (nAb) Post-vaccination
Time frame: Day 1 and Days 31, 91, 181, and 366
KP.2 Cohorts: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Serum nAb Post-vaccination
Time frame: Day 1 and Days 31, 91, 181, and 366
KP.2 Cohorts: Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Binding Antibody (bAb) Against Spike Protein (S) Post-vaccination
Time frame: Days 1, 31, 91, 181, and 366
KP.2 Cohorts: GMFR of Serum IgG Anti-S bAb Post-vaccination
Time frame: Days 1, 31, 91, 181, and 366
KP.2 Cohorts: GMC of Serum Immunoglobulin A (IgA) bAb Against S Post-vaccination
Time frame: Days 1, 31, 91, 181, and 366
KP.2 Cohorts: GMFR of Serum IgA Anti-S Specific bAb Post-vaccination
Time frame: Day 1 and Days 31, 91, 181, and 366
KP.2 Cohorts: GMT of SARS-CoV-2 Specific Saliva nAb Post-vaccination
Time frame: Day 1 and Days 31, 91, 181, and 366
KP.2 Cohorts: GMFR of SARS-CoV-2 Specific Saliva nAb Post-vaccination
Time frame: Day 1 and Days 31, 91, 181, and 366
KP.2 Cohorts: GMC of S-specific Saliva IgA bAb Post-vaccination
Time frame: Days 1, 31, 91, 181, and 366
KP.2 Cohorts: GMFR of S-specific Saliva IgA bAb Post-vaccination
Time frame: Days 1, 31, 91, 181, and 366
KP.2 Cohorts: GMT of SARS-CoV-2 specific Nasal Lining Fluid (NLF) nAb Post-vaccination
Time frame: Days 1, 31, 91, 181, and 366
KP.2 Cohorts: GMFR of SARS-CoV-2 specific NLF nAb Post-vaccination
Time frame: Days 1, 31, 91, 181, and 366
KP.2 Cohorts: GMC of S-specific NLF IgA bAb Post-vaccination
Time frame: Days 1, 31, 91, 181, and 366
KP.2 Cohorts: GMFR of S-specific NLF IgA bAb Post-vaccination
Time frame: Days 1, 31, 91, 181, and 366
KP.2 Cohorts: Percentage of Participants With 2, 3, and 4 Fold Rise in S-specific Serum IgG and IgA bAb, Serum nAb, Saliva IgA bAb, NLF IgA bAb, saliva nAb and NLF nAb Post-vaccination
Time frame: Day 1 and Days 31, 91, 181, and 366
KP.2 Cohorts: Concentration of Intracellular T Cell Cytokine and Cell Surface Marker
Time frame: Days 1, 31, 91, 181, and 366