COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05037097

Arcturus Therapeutics

clinicaltrials@arcturusrx.com

2021-09-08

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: individuals who: are able to provide consent agree to comply with all study visits and procedures are willing and able to adhere to study restrictions are sexually active and willing to adhere to contraceptive requirements are male, female, or transgender ≥21 to ≤80 years of age for the previously vaccinated groups only, received 2 doses of sars-cov-2 vaccine 5 months or longer prior to study enrollment

individuals who: for the unvaccinated groups only, previously received any investigational or authorized mers-cov, sars-cov, and sars-cov-2 vaccines (including arct-021) for the previously vaccinated groups only, previously received bnt162b2 but have not received 2 doses within at least 5 months prior to study enrollment are planning to receive other covid-19 vaccines during the study period recently received other vaccines have a fever or are feeling sick close to the time of the first study vaccination have a known history of covid-19 disease or asymptomatic sars-cov-2 infection are pregnant or breastfeeding have had a severe reaction to previous vaccines have a severe or uncontrolled disease(s) that may interfere with the interpretation of the study have some respiratory diseases have some significant heart diseases have some neurological conditions have sickle cell disease or some other blood disorders have had a major surgery within the past 6 months have a history of chronic liver disease have a history of autoimmune disease or immunodeficiency have received allergy injections, interferon, immunomodulators, cytotoxic drugs or other similar toxic drugs. have received blood products have a positive test for hepatitis b or c or human immunodeficiency virus have uncontrolled hypertension have had cancer except for cancers that were treated and that have low risk of returning are obese are investigator site staff members, employees of arcturus or the contract research organization (cro) directly involved in the conduct of the study, or site staff members otherwise supervised by the investigator or immediate family members of any of the previously mentioned individuals

6

Arcturus Therapeutics, Inc.

21

80

Singapore;United States

Healthy volunteers

N/A

72

Changes in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs;Changes in SARS-CoV-2 serum neutralizing levels from before vaccination to each subsequent time point, expressed as GMFRs;GMT ratio (ARCT-021/ARCT-165, ARCT-165/ARCT-154, and ARCT-021/ARCT-154);Percentage of participants reporting adverse events leading to discontinuation from study vaccine/study withdrawal;Percentage of participants reporting medically attended adverse events;Percentage of participants reporting serious adverse events;Percentage of participants reporting solicited local or systemic adverse events;Percentage of participants reporting unsolicited adverse events;Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels;Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels;SARS-CoV-2 full-length spike, RBD, and N binding antibody levels, expressed as GMCs;SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs

None

Phase 1/Phase 2

[{"arm_notes": "2;Days1-29;Not Previously Vaccinated", "treatment_id": 1902, "treatment_name": "Arct-165", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Days1-29;Not Previously Vaccinated", "treatment_id": 1900, "treatment_name": "Arct-154", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Days1-29;Not Previously Vaccinated", "treatment_id": 1901, "treatment_name": "Arct-021", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1;day 1;Previously Vaccinated", "treatment_id": 1902, "treatment_name": "Arct-165", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1;day 1;Previously Vaccinated", "treatment_id": 1900, "treatment_name": "Arct-154", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1;day 1;Previously Vaccinated", "treatment_id": 1901, "treatment_name": "Arct-021", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]