Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARCT-165 · 1 trial · 3 indications
Solicited local AEs were defined as injection site erythema, injection site pain, injection site induration, and injection site tenderness. Solicited systemic AEs were defined as arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, nausea and vomiting. Data are reported for the number of participants with solicited local and solicited systemic AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Unsolicited AEs were defined as any spontaneously reported or discovered AE. Data are reported for the number of participants with unsolicited AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) with a health care provider (HCP) (e.g., nurse, nurse practitioner, physician's assistant, physician), including visits to a study site for unscheduled assessments (e.g., rash assessment, abnormal laboratory follow up, coronavirus disease 2019 \[COVID-19\]) and visits to HCPs external to the study site (e.g., urgent care, primary care 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. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral D614G variant. Data are reported in international units per milliliter (IU/mL).
Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral B.1.351 (beta) variant. Data are reported in arbitrary units per milliliter (AU/mL).
Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral D614G variant.
Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral B.1.351 (beta) variant.
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G variant.
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral B.1.351 (beta) variant.
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154. Data are reported for the ARCT-165 and ARCT-021 arms (vs ARCT-154 values).
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-021 vs ARCT-165. Data are reported for the ARCT-021 arm (vs ARCT-165 values).
Spike binding antibody levels expressed as GMCs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibodies for ancestral strain.
Spike binding antibody levels expressed as GMFRs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibody levels expressed as GMFR for ancestral strain.
Data are reported for ancestral, D614G, and B.1.351 variants for Spike binding antibodies and ancestral for RBD binding antibodies.
| Arm | Type | Description |
|---|---|---|
| Study Group 1, Adult Participants Seronegative, Not Previously Vaccinated randomized to ARCT-165 | EXPERIMENTAL | Participants will receive one dose of ARCT-165 on Day 1 and one dose of ARCT-165 on Day 29 |
| Study Group 2, Adult Participants Seronegative, Not Previously Vaccinated randomized to ARCT-154 | EXPERIMENTAL | Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29 |
| Study Group 3, Adult Participants Seronegative, Not Previously Vaccinated to receive ARCT-021 | EXPERIMENTAL | Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29 |
| Study Group 4, Adult Participants Seropositive, Not Previously Vaccinated to receive ARCT-021 | EXPERIMENTAL | Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29 |
| Study Group 5, Adult Participants Seropositive, Not Previously Vaccinated randomized to ARCT-154 | EXPERIMENTAL | Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29 |
| Study Group 6, Adult Participants Previously Vaccinated randomized to receive ARCT-165 | EXPERIMENTAL | Participants will receive one dose of ARCT-165 on Day 1 |
| Study Group 7, Adult Participants Previously Vaccinated randomized to receive ARCT-154 | EXPERIMENTAL | Participants will receive one dose of ARCT-154 on Day 1 |
| Study Group 8, Adult Participants Previously Vaccinated randomized to receive ARCT-021 | EXPERIMENTAL | Participants will receive one dose of ARCT-021 on Day 1 |
| Name | Type | Description |
|---|---|---|
| ARCT-165 | BIOLOGICAL | Dose 3 |
| ARCT-154 | BIOLOGICAL | Dose 2 |
| ARCT-021 | BIOLOGICAL | Dose 1 |
Inclusion Criteria: Individuals who: 1. Are able to provide consent 2. Agree to comply with all study visits and procedures 3. Are willing and able to adhere to study restrictions 4. Are sexually active and willing to adhere to contraceptive requirements 5. Are male, female, or transgender ≥21 to ...
ARCT-165 is an investigational COVID-19 vaccine being developed for the prevention of COVID-19, which is caused by the SARS-CoV-2 virus. It is designed to be administered to healthy adults to generate an immune response against the virus. The vaccine is currently in clinical development and has not been approved for use.
ARCT-165 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 safety and immunogenicity of this COVID-19 vaccine candidate.
ARCT-165 is in Phase 1 clinical development. It is an investigational COVID-19 vaccine that has completed a Phase 1 trial. The vaccine is not yet approved by regulatory authorities and remains under investigation for safety and immunogenicity in healthy adults.
ARCT-165 was evaluated in a Phase 1 clinical trial with the identifier NCT05037097. This trial assessed the safety and immunogenicity of three COVID-19 SARS-CoV-2 RNA vaccines in healthy adults. The study enrolled 72 participants and was conducted in the United States, Singapore, and South Africa. The trial has been completed.
ARCT-165 is classified as a monoclonal antibody modality, but it is being developed as a COVID-19 vaccine. It is designed to elicit an immune response against SARS-CoV-2. The vaccine is administered to healthy adults and is currently in Phase 1 clinical development.