Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine · 1 trial · 1 indication
Solicited local ARs included injection site erythema, injection site pain, injection site induration/swelling, and injection site tenderness. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Solicited systemic ARs included arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, and nausea/vomiting. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Unsolicited AEs were defined as any spontaneously reported or discovered AE. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
An MAAE was defined as an AE that led to an unscheduled visit (including a telemedicine visit) with a healthcare provider (\[HCP\], e.g., nurse, nurse practitioner, physician's assistant, physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect arising from a pregnancy conceived after receipt of study vaccine. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Data are presented for the number of participants with a NAb seroconversion response as determined by the surrogate virus neutralization test (sVNT). Seroconversion was defined as a ≥4-fold increase in antibody concentration from baseline.
COVID-19 was defined as a positive SARS-CoV-2 test and at least one of the following that was a new or worsening finding: ⦁ Fever or chills ⦁ Cough ⦁ Shortness of breath or difficulty breathing ⦁ Fatigue ⦁ Muscle or body aches ⦁ Headache ⦁ New loss of taste or smell ⦁ Sore throat ⦁ Congestion or runny nose ⦁ Nausea or vomiting ⦁ Diarrhea Data are presented for the number of participants with a first occurrence of COVID-19 with no evidence of prior infection.
| Arm | Type | Description |
|---|---|---|
| ARCT-154 | EXPERIMENTAL | Each participant is planned to receive a two-dose vaccination series of ARCT-154 at a dose of 5 µg with 28 day interval in the first vaccination series. |
| Placebo | PLACEBO_COMPARATOR | Each participant is planned to receive a two-dose vaccination series of placebo (normal saline) with 28 day interval in the first vaccination series. |
| Astra Zeneca COVID-19 vaccine | ACTIVE_COMPARATOR | Each participant is planned to receive a two-dose vaccination series of Astra Zeneca COVID-19 vaccine with 28 day interval in the first vaccination series. |
| Name | Type | Description |
|---|---|---|
| ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine | BIOLOGICAL | ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine |
| Placebo (normal saline) | OTHER | Normal saline with the same volume as of ARCT-154 |
| Astra Zeneca COVID-19 vaccine | BIOLOGICAL | Astra Zeneca COVID-19 vaccine (ChAdOx1 nCoV-19) |
Inclusion Criteria: Individuals who: 1. are able to provide consent 2. agree to comply with all study visits and procedures 3. are of childbearing potential and sexually active must be willing to adhere to contraceptive requirements 4. are male or female ≥18 years of age (or, for Phase 1, 18 to \<...
ARCT-154 is an investigational vaccine developed by Arcturus Therapeutics Holdings Inc. for the prevention of COVID-19. It uses self-amplifying RNA technology and is designed to stimulate an immune response against SARS-CoV-2. The vaccine has been studied in a Phase 2 clinical trial.
ARCT-154 is being developed for the prevention of COVID-19, which is caused by the SARS-CoV-2 virus. It is intended for use in adults 18 years of age and older. The vaccine is designed to elicit an immune response that may protect against COVID-19.
ARCT-154 is being developed by Arcturus Therapeutics Holdings Inc., a biopharmaceutical company. The company's ticker symbol is ARCT. Arcturus specializes in mRNA medicines and vaccines.
ARCT-154 is in Phase 2 clinical development. It has not been approved by the FDA or any regulatory agency. The vaccine is still being evaluated in clinical trials to assess its safety and efficacy.
ARCT-154 has been studied in a Phase 2 clinical trial, NCT05012943, titled 'The ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study (ARCT-154-01)'. This completed trial enrolled 19,474 participants in Vietnam. It was randomized, double-blind, and placebo-controlled.