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 self-amplifying RNA vaccine being studied for the prevention of COVID-19. It is currently in Phase 2 clinical development and is not yet approved for use. The vaccine is designed to generate an immune response against SARS-CoV-2, the virus that causes COVID-19.
ARCT-154 is being developed by Arcturus Therapeutics Holdings Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy for COVID-19 prevention. Arcturus Therapeutics is publicly traded under the ticker symbol ARCT.
ARCT-154 is currently in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The vaccine is being studied for its ability to prevent COVID-19, and clinical trials are ongoing to assess its safety and efficacy.
ARCT-154 has been studied in a Phase 2 clinical trial with the identifier NCT05012943, titled 'The ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study (ARCT-154-01)'. This randomized, double-blind, placebo-controlled trial enrolled 19,474 participants in Vietnam and has been completed.
Yes, ARCT-154 is a self-amplifying RNA (saRNA) vaccine. This means it contains RNA that can replicate itself within cells, potentially producing more antigen and stimulating a stronger immune response compared to conventional mRNA vaccines. It is being developed for COVID-19 prevention.