Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VXA-A1.1 Oral Vaccine, VXA-A1.1
VXA-A1.1 Vaccine · 3 trials · 2 indications
The clinical efficacy of VXA-A1.1 to protect against illness caused by the homologous A strain influenza virus with challenge 3 months following a single immunization in comparison to placebo and QIV. Participants were evaluated for clinical signs and symptoms of influenza as well as for viral shedding via PCR for confirmation of infection.
Frequency and magnitude of adverse events
| Arm | Type | Description |
|---|---|---|
| Oral Vaccine (VXA-A1.1) | EXPERIMENTAL | Oral enteric coated vaccine tablets. Placebo (saline solution) IM injection will also be administered in this arm. |
| QIV IM Injection | ACTIVE_COMPARATOR | A commercially available QIV will be administered at the approved dose level as the active comparator. Oral placebo tablets will also be administered in this arm. |
| Oral and IM Placebo | PLACEBO_COMPARATOR | Two forms or placebos (saline IM injection and oral placebo tablets) will be administered in this arm. |
| VXA-A1.1 | EXPERIMENTAL | Intestinal Delivery |
| Low Dose VXA-A1.1 Oral Vaccine | EXPERIMENTAL | Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation. |
| VXA Placebo Tablet | PLACEBO_COMPARATOR | Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design. |
| Medium Dose VXA-A1.1 Oral Vaccine | EXPERIMENTAL | Two doses of replication incompetent adenovirus vaccine given in an oral tablet |
| High Dose VXA-A1.1 Oral Vaccine | EXPERIMENTAL | One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003. |
| Name | Type | Description |
|---|---|---|
| VXA-A1.1 | BIOLOGICAL | Enteric coated oral vaccine tablet |
| Fluzone® | BIOLOGICAL | Fluzone Quadravalent (Fluzone®) influenza vaccine (QIV) suspension for intramuscular (IM) injection |
| Placebo Tablets | OTHER | Placebo tablets similar in size, color and number to the active oral tablet vaccine drug product |
| Saline Solution for Placebo IM Injection | OTHER | - |
| VXA-A1.1 Oral Vaccine | BIOLOGICAL | One or two doses of replication incompetent adenovirus oral tablet vaccine |
| VXA Placebo Tablet | BIOLOGICAL | Off-white tablets similarly formulated to the active drug product tablets. |
Inclusion Criteria: 1. Male or female volunteers aged 18 - 49 years, inclusive 2. Able to give written informed consent 3. Low pre-existing antibodies to the study vaccine 4. In general good health (no clinically significant health concerns) 5. Safety laboratory normal range or not clinically signi...
Top 8 of 10 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE2 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4117, AZD5315 |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |