Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VXA-CoV2-3.1 · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| VXA-CoV2-3.1 Safety Sentinel Cohort | EXPERIMENTAL | Participants previously immunized against COVID-19 infection will be randomized to receive VXA-CoV2-3.1 (XBB.1.5 vaccine) tablet oral vaccine. |
| COMIRNATY® Safety Sentinel Cohort | ACTIVE_COMPARATOR | Participants previously immunized against COVID-19 infection will be randomized to receive COMIRNATY® (variant matched vaccine 2023-2024 formula) injectable COVID-19 vaccine. |
| VXA-CoV2-3.3 | EXPERIMENTAL | If no dose-related toxicities are observed, and upon the recommendation of the Data and Safety Monitoring Board following review of Day 31 safety data in the initial safety cohorts (and possibly immunogenicity data), enrollment will continue with the remaining participants who will be randomized to receive a single dose of VXA-CoV2-3.3 (KP.2 vaccine). |
| COMIRNATY® | ACTIVE_COMPARATOR | If no dose-related toxicities are observed, and upon the recommendation of the Data and Safety Monitoring Board following review of Day 31 safety data in the initial safety cohorts (and possibly immunogenicity data), enrollment will continue with the remaining participants who will be randomized to receive a single dose of 2024-2025 formula of COMIRNATY® mRNA COVID-19 injectable vaccine. |
| Name | Type | Description |
|---|---|---|
| VXA-CoV2-3.1 | BIOLOGICAL | Tablets for oral use. |
| COMIRNATY® | BIOLOGICAL | Intramuscular (IM) injection. |
| VXA-CoV2-3.3 | BIOLOGICAL | Tablets for oral use. |
Inclusion Criteria: 1. Adults 18 years of age and above, at time of screening. 2. Completed primary approved/authorized COVID-19 vaccination series and have received ≥ 2 mRNA vaccine doses. 3. Last COVID-19 vaccine received ≥6 months prior to study vaccination. 4. Male and female participants of ch...