VXA-CoV2-1 is a non-replicating Ad5 vector adjuvanted oral tableted vaccine being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to evaluate the safety and immunogenicity of VXA-CoV2-1 vaccine with repeat dosing at multiple dose levels. Safety and immunogenicity will be evaluated for up to 12 months after the second dose of VXA-CoV2-1.
This is an open-label, dose-ranging trial to determine the safety and immunogenicity of an orally administered adenoviral-vector based vaccine (VXA-COV2-1) expressing a SARS-CoV-2 antigen and dsRNA adjuvant. Post screening activities, healthy adult volunteers aged 18 - 54 yrs old, inclusive, will be enrolled into the study. Participants will receive an oral dose of vaccine at Days 1 and a subject will also receive a second dose at Day 29; total study period will last \~ 2 months during the active phase, with a total 12 month safety follow-up period post last vaccination. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the study active and follow-up periods. Subjects will be monitored for symptoms of COVID-19 throughout the duration of the study follow-up period. Approximately 10 healthy male and female adult volunteers 18 to 54 years old who were enrolled in the main study will be included in a boost extension substudy for an additional 12 months from dosing for a total participation period of 24-25 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
35
non replicating Ad5 adjuvanted oral tableted vaccine
WCCT
Cypress, California, United States
Frequency of solicited symptoms of reactogenicity
Subject reported symptoms of local and systemic reactogenicity
Time frame: Day 1 through Day 8 post each immunization
Grade of solicited symptoms of reactogenicity
Subject reported symptoms of local and systemic reactogenicity
Time frame: Day 1 through Day 8 post each immunization
Frequency of unsolicited adverse events
Any adverse events observed or reported following vaccination
Time frame: Day 1 through Day 29 post each immunization
Grade of unsolicited adverse events
Any adverse events observed or reported following vaccination
Time frame: Day 1 through Day 29 post each immunization
Frequency of serious adverse events (SAEs)
Any adverse events reported following vaccination meeting definition of serious
Time frame: Day 1 through Day 390
Frequency of medically-attended adverse events (MAAEs)
Any adverse events reported following vaccination meeting definition of serious
Time frame: Day 1 through Day 390
SARS-CoV-2 specific IgG/IgA
SARS-CoV-2 specific IgG/IgA by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 1 through Day 390
Neutralizing antibody titers to SARS-CoV-2
serum based assay of Ab titers
Time frame: Day 1 through Day 390
Antigen-specific IgG/IgA antibody secreting (ASCs)
ASCs by ELISpot
Time frame: Day 1 through Day 44
Th1/Th2 polarization
Flow Cytometry
Time frame: Day 1 through Day 44
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