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ARCT-2303 · 1 trial · 1 indication
Seroconversion was defined as either a pre-vaccination titer below the lower limit of quantitation (LLOQ) and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer.
Influenza vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata.
| Arm | Type | Description |
|---|---|---|
| Group 1a (ARCT-2303/Influenza vaccine) | EXPERIMENTAL | Participants will receive one 0.5-mL IM (intramuscular) dose of ARCT-2303 and one 0.5-mL IM dose of influenza vaccine on Day 1 followed by a 0.5-mL IM dose of placebo on Day 29. |
| Group 2a (ARCT-2303) | EXPERIMENTAL | Participants will receive one 0.5-mL IM dose of ARCT-2303 and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of influenza vaccine on Day 29. |
| Group 3a (Influenza vaccine) | ACTIVE_COMPARATOR | Participants will receive one 0.5-mL IM dose of influenza vaccine and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of ARCT-2303 on Day 29. |
| Group 1b (ARCT-2303/ Influenza vaccine) | EXPERIMENTAL | Participants will receive one 0.5-mL IM dose of ARCT-2303 and one 0.5-mL IM dose of influenza vaccine on Day 1 followed by a 0.5-mL IM dose of placebo on Day 29. |
| Group 2b (ARCT-2303) | EXPERIMENTAL | Participants will receive one 0.5-mL IM dose of ARCT-2303 and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of influenza vaccine on Day 29. |
| Group 3b (Influenza vaccine) | ACTIVE_COMPARATOR | Participants will receive one 0.5-mL IM dose of influenza vaccine and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of ARCT-2303 on Day 29. |
| Name | Type | Description |
|---|---|---|
| ARCT-2303 | BIOLOGICAL | Self-Amplifying RNA COVID-19 vaccine (Omicron XBB.1.5) |
| Influenza vaccine | BIOLOGICAL | Licensed cell-based influenza vaccine |
| Influenza vaccine, adjuvanted | BIOLOGICAL | Licensed influenza vaccine, adjuvanted |
| Placebo | OTHER | 0.9% saline |
Inclusion Criteria: 1, Individuals are male, female, or transgender adults ≥18 years of age. 2\. Healthy participants or participants with pre-existing stable medical conditions. 3\. Participant or legally authorized representatives must freely provide documented informed consent prior to study p...
ARCT-2303 is an investigational self-amplifying mRNA COVID-19 vaccine being developed for the prevention of COVID-19. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
ARCT-2303 is being developed by Arcturus Therapeutics Holdings Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ARCT. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
ARCT-2303 is in Phase 3 clinical development as an investigational COVID-19 vaccine. It has completed one Phase 3 trial and is not yet approved for use, meaning it remains under clinical investigation.
ARCT-2303 has been studied in a completed Phase 3 clinical trial with the identifier NCT06279871. This trial evaluated the immunogenicity and safety of the vaccine when administered with influenza vaccines in adults, enrolling 1,514 participants across Australia, Costa Rica, Honduras, and the Philippines.
No, ARCT-2303 is not a monoclonal antibody. It is a self-amplifying mRNA vaccine designed to induce an immune response against COVID-19. The modality classification as a monoclonal antibody in some databases is incorrect based on the available trial information.