COVID-19 Clinical Trial
Official title:
A Phase 3, Multicenter, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of a Self-Amplifying RNA COVID-19 Vaccine (ARCT-2303), Administered Concomitantly With Quadrivalent Influenza Vaccines, in Adults
Verified date | June 2024 |
Source | Arcturus Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine.
Status | Active, not recruiting |
Enrollment | 1680 |
Est. completion date | December 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1, Individuals are male, female, or transgender adults =18 years of age. 2. Healthy participants or participants with pre-existing stable medical conditions. 3. Participant or legally authorized representatives must freely provide documented informed consent prior to study procedures being performed. 4. Individuals must have been previously vaccinated with COVID-19 vaccines. 5. Individuals of childbearing potential must be willing to adhere to contraceptive requirements. Exclusion Criteria: 1. Individuals with acute medical illness or febrile illness. 2. Individuals with a positive SARS-CoV-2 rapid antigen test at Screening. 3. Individuals with a history of COVID-19 or virologically confirmed SARS-CoV-2 infection within the past 5 months or history of COVID-19 with ongoing sequelae. 4. Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any components of mRNA vaccine, or influenza vaccine, including egg protein. 5. Individuals who have a positive pregnancy test at the Screening visit or who intend to become pregnant or breastfeed during the study. 6. Individuals with a history of myocarditis, pericarditis, myopericarditis or cardiomyopathy. 7. Individuals with a history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis. 8. Individuals with a history of congenital or acquired immunodeficiency. 9. Individuals who have received immunomodulatory, immunostimulatory, or immunosuppressant drugs within 3 months of Screening; or individuals requiring systemic corticosteroids exceeding 10 mg/day of prednisone equivalent for =10 days within 30 days of Screening. 10. Individuals who have received immunoglobulins and/or any blood or blood products within the 3 months before the first vaccine administration or plan to receive such products at any time during the study. 11. Individuals with a documented history of HIV infection, or who are currently known to have active tuberculosis. 12. Individuals receiving treatment with another investigational drug, biological agent, or device. 13. Individuals who have received any investigational COVID-19 vaccines. 14. Individuals who received any influenza vaccine within 6 months prior to enrollment or plan to receive an influenza vaccine during the study period. 15. Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 14 days after the study vaccination. 16. Individuals who are investigator site staff members, employees of the Sponsor or the Clinical Research Organization 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. |
Country | Name | City | State |
---|---|---|---|
Australia | CMAX | Adelaide | South Australia |
Australia | Nucleus Network Brisbane (Q-Pharm) | Brisbane | Queensland |
Australia | Paratus Clinical Brisbane | Brisbane | Queensland |
Australia | USC Southbank | Brisbane | Queensland |
Australia | Paratus Clinical Canberra | Canberra | Australian Capital Territory |
Australia | Paratus Clinical Central Coast | Central Coast | New South Wales |
Australia | Austrials -Sunshine | Melbourne | Victoria |
Australia | Emeritus Research Melbourne | Melbourne | Victoria |
Australia | Nucleus Network | Melbourne | Victoria |
Australia | The Peter Doherty Institute for Infection and Immunity | Melbourne | Victoria |
Australia | Veritus Research | Melbourne | Victoria |
Australia | Sutherland Shire Clinical Research - Walski | Miranda | New South Wales |
Australia | USC Morayfield | Morayfield | Queensland |
Australia | Clinitrials - Mount Site | Perth | Western Australia |
Australia | USC Sippy Down | Sunshine Coast | Queensland |
Australia | Australian Clinical Research Network (ACRN) | Sydney | New South Wales |
Australia | Austrials - St. Leonards | Sydney | New South Wales |
Australia | Emeritus Research Sydney | Sydney | New South Wales |
Australia | Griffith University Clinical Trials Unit | Sydney | New South Wales |
Australia | Northern Beaches Clinical Research - Walski | Sydney | New South Wales |
Australia | Paratus Clinical Blacktown | Sydney | New South Wales |
Australia | Wollongong Clinical Research | Wollongong | New South Wales |
Costa Rica | IICIMED | San Jose | |
Costa Rica | Clínica San Agustín | San José | |
Honduras | Organización y centro de investigación clínica Ochoa (OCINCO) | Comayagua | |
Honduras | Deposito de Medicamentos de Investigación Cousin Agustín (DEMEDICA) | San Pedro Sula | |
Honduras | Inversiones en Investigación Médica S.A (INVERIME) | Tegucigalpa | |
Philippines | Tropical Disease Foundation - Putatan Health Center | Muntinlupa City | |
Philippines | Far Eastern University - Nicanor R. M Foundation | Quezon City |
Lead Sponsor | Collaborator |
---|---|
Arcturus Therapeutics, Inc. | Novotech (Australia) Pty Limited, Seqirus |
Australia, Costa Rica, Honduras, Philippines,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SARS-CoV-2 neutralizing antibody titers | Immune response as measured by geometric mean titers (GMTs) of neutralizing antibodies against Omicron XBB.1.5 subvariant (Groups 2a and 2b; a comparator group from a previous study) | Day 29 | |
Primary | SARS-CoV-2 neutralizing antibody seroconversion rates | Immune response as measured by SARS-CoV-2 neutralizing antibody seroconversion rates against Omicron XBB.1.5 subvariant (Groups 2a and 2b; a comparator group from a previous study) | Day 29 | |
Primary | Hemagglutination Inhibition (HI) titers | Immune response as measured by GMTs against influenza vaccine strains (Group 1a; Group 3a) | Day 1, Day 29 | |
Primary | SARS-CoV-2 neutralizing antibody titers | Immune response as measured by GMTs of neutralizing antibodies against Omicron XBB.1.5 subvariant (Group 1a; Group 2a) | Day 29 | |
Secondary | SARS-CoV-2 neutralizing antibody titers | GMTs of SARS-CoV-2 neutralizing antibody titers against Omicron XBB.1.5 subvariant (Groups 2a and 2b; a comparator group from a previous study) | Day 29 | |
Secondary | SARS-CoV-2 neutralizing antibody seroconversion rates | SARS-CoV-2 neutralizing antibody seroconversion rates against Omicron XBB.1.5 subvariant (Groups 2a and 2b; a comparator group from a previous study) | Day 29 | |
Secondary | SARS-CoV-2 neutralizing antibody response (Group 1a; Group 2a) | SARS-CoV-2 neutralizing antibody responses against Omicron XBB.1.5 subvariant as measured by GMT, Geometric Mean Fold Rise (post/pre-vaccination), proportion of participants with seroconversion and proportion of participants with antibody titer = lower limit of quantitation (LLOQ) (Group 1a; Group 2a) | Days 1, 29 and 181 | |
Secondary | Hemagglutination Inhibition (HI) titers | HI assay titers against influenza vaccine strains as measured by GMT, Geometric Mean Fold Rise (post/pre-vaccination), proportion of participants with seroconversion and proportion of participants with HI titers =1:40 (Group 1a; Group 3a) | Day 1, Day 29 | |
Secondary | SARS-CoV-2 neutralizing antibody responses | SARS-CoV-2 neutralizing antibody responses against Omicron XBB.1.5 subvariant as measured by GMT, Geometric Mean Fold Rise (post/pre-vaccination), proportion of participants with seroconversion and proportion of participants with antibody titer = LLOQ (Group 1b; Group 2b) | Day 181 | |
Secondary | Hemagglutination Inhibition (HI) assay titers | HI assay titers against influenza vaccine strains as measured by GMT, Geometric Mean Fold Rise (post/pre-vaccination), proportion of participants with seroconversion and proportion of participants with HI titers =1:40 (Group 1b; Group 3b) | Day 29 | |
Secondary | Local and systemic adverse events (AEs) | Proportion of participants with local and systemic solicited AEs | Day 1 to Day 8 after each vaccination | |
Secondary | Unsolicited AEs | Proportion of participants with unsolicited AEs | Day 1 to Day 29 after each vaccination | |
Secondary | SAE, Medically Attended Adverse Events (MAAE), Adverse Events of Special Interest (AESI), and AE leading to early termination | Proportion of participants with SAE/MAAE/AESI/AE leading to early termination from study | Day 1 to Day 181 |
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