Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARCT-2304 · 1 trial · 1 indication
The following solicited local and systemic AEs were recorded from Day 1 to 7 days after each vaccination (dose): Injection site pain, Erythema, Swelling, Fatigue, Headache, Myalgia, Arthralgia, Dizziness, Nausea, Chills, Fever (≥100.4 °Fahrenheit \[F\] /≥38.0 °Celsius \[C\]). A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section.
An AE was any untoward medical occurrence in a participant or participant administered a medicinal product, whether or not considered related to the trial vaccine. An unsolicited AE was defined as any AE not included in the list of solicited AEs (i.e., any event other than injection site pain, erythema, swelling, fatigue, headache, myalgia, arthralgia, dizziness, nausea, chills, or fever (≥100.4 °F / ≥38.0 °C). Solicited AEs that lasted for more than 7 days were considered as unsolicited AEs. Unsolicited AEs were recorded from Day 1 up to 28 days after each vaccination (dose). A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section'.
An SAE was defined as any AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity, or required inpatient hospitalization or prolongation of existing hospitalization. AEs potentially associated with messenger ribonucleic acid (mRNA) vaccines and influenza vaccines were reported as AESIs. MAAEs were defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic, or other visits (including phone/telehealth visits) to or from medical personnel for any reason but did not fulfil seriousness criteria. A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section'.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Antibody titers were expressed as Geometric Mean Titers.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Antibody titers were expressed as Geometric Mean Titers.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Geometric Mean Fold Rise was reported as a ratio to Day 1.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Geometric Mean Fold Rise was reported as a ratio to Day 1.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Seroconversion was recorded if participant had pre-vaccination antibody titer \< Lower Limit Of Quantitation (LLOQ) and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Seroconversion was recorded if participant had pre-vaccination antibody titer \< LLOQ and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
| Arm | Type | Description |
|---|---|---|
| Low dose of ARCT-2304, Schedule 1, Young Adults | EXPERIMENTAL | Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| Mid dose of ARCT-2304, Schedule 1, Young Adults | EXPERIMENTAL | Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| High dose of ARCT-2304, Schedule 1, Young Adults | EXPERIMENTAL | High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| Control, Schedule 1, Young Adults | ACTIVE_COMPARATOR | Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: Comparator vaccine younger adult and saline placebo vaccine |
| Low dose of ARCT-2304, Schedule 1, Older Adults | EXPERIMENTAL | Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| Mid dose of ARCT-2304, Schedule 1, Older Adults | EXPERIMENTAL | Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| High dose of ARCT-2304, Schedule 1, Older Adults | EXPERIMENTAL | High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| Control, Schedule 1, Older Adults | ACTIVE_COMPARATOR | Older Adults Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: Comparator vaccine older adult and saline |
| Low dose of ARCT-2304, Schedule 2, Young Adults | EXPERIMENTAL | Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| Mid dose of ARCT-2304, Schedule 2, Young Adults | EXPERIMENTAL | Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| High dose of ARCT-2304, Schedule 2, Young Adults | EXPERIMENTAL | High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| Control, Schedule 2, Young Adults | ACTIVE_COMPARATOR | Young Adults Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: Comparator vaccine younger adult and saline placebo vaccine |
| Low dose of ARCT-2304, Schedule 2, Older Adults | EXPERIMENTAL | Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| Mid dose of ARCT-2304, Schedule 2, Older Adults | EXPERIMENTAL | Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| High dose of ARCT-2304, Schedule 2, Older Adults | EXPERIMENTAL | High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| Control, Schedule 2, Older Adults | ACTIVE_COMPARATOR | Older Adults Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: Comparator vaccine older adult and saline placebo vaccine |
| Name | Type | Description |
|---|---|---|
| ARCT-2304 | BIOLOGICAL | Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle. |
| Control vaccine younger adults | BIOLOGICAL | Each participant will receive one intramuscular (IM) dose into the deltoid muscle. |
| Control vaccine older adults | BIOLOGICAL | Each participant will receive one intramuscular (IM) dose into the deltoid muscle. |
| Placebo Vaccine | OTHER | Each participant will receive one intramuscular (IM) dose into the deltoid muscle. |
Main Inclusion Criteria: * Individuals are male or female adults 18-80 years of age. * Healthy participants or participants with pre-existing stable medical conditions. * Individuals of childbearing potential must be willing to adhere to contraceptive requirements. Main Exclusion Criteria: * Indi...
ARCT-2304 is an investigational vaccine being developed for the prevention of influenza in humans. It is currently in Phase 1 clinical development and is being studied for its safety and immunogenicity in adults.
ARCT-2304 is being developed by Arcturus Therapeutics Holdings Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the vaccine's safety and immune response in adults.
ARCT-2304 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety and immunogenicity.
ARCT-2304 has one completed Phase 1 clinical trial, NCT06602531, titled 'Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults.' The trial enrolled 212 participants in the United States and was randomized, double-blind, and active-controlled.
ARCT-2304 is a self-amplifying RNA vaccine, as indicated by the clinical trial title. It is designed to encode antigens that elicit an immune response against influenza. The vaccine is administered to healthy adult volunteers.