A Phase Ⅲ Clinical Trial of Influenza Virus Vector COVID19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1

PHRR220209-004269

COVID-19-PRO-003

2021-CT0635

A Phase Ⅲ Clinical Trial of Influenza Virus Vector COVID19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1

Protocol Title: A Global, Multi-center, Randomized, Double-blind, Placebo controlled Phase III Clinical Trial to Evaluate the Protective Efficacy and Safety of Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) in Adults Aged 18 Years and Older

Project name: A Phase Ⅲ Clinical Trial of Influenza Virus Vector COVID19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1

Ongoing

This study aims to provide data support for registration application of the preventive vaccine, i.e., influenza virus vector COVID-19 vaccine for intranasal spray (DelNS1-2019-nCoV-RBDOPT1), against COVID-19 so that approval of the regulatory authorities can be obtained. The data will also support the WHO prequalification application. The study sites selected for this study are located in areas where the population is at a relatively high risk.

1) 1. To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity at least 14 days after the first vaccination (≥15 days); 2) To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of different severities; 3) To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in all subjects with symptomatic COVID-19 during the follow-up period; 4) To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in different countries; 5) To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity caused by the variant of concern (VOC); 6) To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 for preventing virologically confirmed (RT-PCR-positive) influenza A

To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against severe COVID-19; 2) To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in different age groups; 3) To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against virologically -confirmed (RT-PCR-positive) COVID-19 deaths; 4) To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against symptomatic COVID-19 of any severity in patients with chronic diseases, To evaluate the protective efficacy of DelNS1-2019-nCoV-RBD-OPT1 against virologically confirmed (RT-PCR positive) symptomatic COVID-19 in subjects previously administered with COVID-19 vaccine.

Recruiting

Clinical Trial

2021-CT0635

2021-11-16

0000-00-00

14000

Unspecified

Unspecified

0000-00-00

Inclusion Criteria Subjects participating in this study need to meet all the following criteria: 1) Aged ≥18 years old at the time of enrollment; 2) Be able to comply with the requirements of clinical study protocol and complete all trial procedures, and sign informed consent form; 3) Subjects who have not received any COVID-19 vaccine (marketed or investigational), those who have received at least one dose of other COVID-19 vaccines (marketed or investigational) with an interval of ≥ 6 months between the last dose and the date when the subjects sign the informed consent for this study; 4) Those who are negative for HIV screening (depending on the relevant policy of the country where the trial is conduct, if qualification for HIV testing is required in the country, this information will be obtained mainly by inquiry while protecting the candidate’s privacy) 5) Fertile males and females of childbearing potential who are willing to take appropriate contraceptive measures from signing ICF to 3 months after the last dose, including abstinence or effective contraceptive measures (e.g., intrauterine or implantable contraceptive devices, oral contraception, combination of contraceptive diaphragm or condom with contraceptive gel); women of childbearing potential should be negative for pregnancy test on the day of vaccination. 6) Healthy people or people with a mild underlying disease that has remained stable without exacerbation (not requiring hospitalization or without major modification of the treatment regimen) within at least 3 months prior to inclusion in the study.

Exclusion Criteria Subjects who meet any one of the following criteria will be excluded from this study: 1) Prior history of COVID-19; 2) Positive test of total SARS-CoV-2 specific antibody using colloidal gold reagent [Only applicable to subjects without vaccination history of COVID-19 vaccine (marketed or investigational)]; 3) Pregnant or lactating women; 4) Fever on the day of vaccination or within 3 days prior to vaccination (oral temperature ≥37.5℃/axillary temperature ≥37.3℃); 5) Those who had any acute disease in the past 5 days that requires systemic antibiotic or antiviral treatment (including but not limited to the use of anti-influenza virus drugs such as Tamiflu, Relenza, Symmetrel or Flumadine); 6) Those who had low immune function caused by immunodeficiency diseases, diseases of important organs, cancer, and immune diseases (e.g. Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy caused by any condition, and other immune disease that may affect immune response at the investigator’s discretion); 7) Long-term use (defined as ≥14 days) of immunosuppressants or other immunomodulators (for glucocorticoids, e.g., ≥10 mg/day prednisone or equivalent dose; inhaled and topical steroids are allowed) within 6 months prior to the first vaccination; 8) History of hemorrhagic diseases (e.g., factor deficiency, thrombocytopenia or other coagulation disorders), or hemorrhagic tendency, or continuous requirement of anticoagulants; 9) Having received immunoglobulins and/or blood products within 3 months before receiving the investigational vaccine; 10) Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination; 11) Participation in a clinical trial of another product within 1 month prior to vaccination, or planning to participate in a clinical trial of another product during the study;12) Having a history of severe allergic reactions or severe adverse reactions from previous immunizations, or allergy to any component of the investigational vaccine; 13) Patients deemed by the investigator as unsuitable for using nasal spray (those with severe rhinitis or nasal deformities, etc.); 14) Planning to relocate permanently from the current area prior to the completion of the study or to leave the current area for a long period (preventing compliance with the prescribed visit schedule) during the study visits; 15) Other conditions that the investigators consider unsuitable for this clinical study.

Interventional

Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1)

Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1)

None

Randomized

Double Blind

Unspecified

Single

The novel coronavirus pneumonia (COVID-19) caused by the novel coronavirus (SARS-CoV-2) is a new acute respiratory infectious disease and has become a major global public health event. Globally, several COVID-19 vaccines have been approved for conditional marketing or emergency use and large-scale vaccination is being carried out. The phase I/II clinical trials (ChiCTR2000037782/ChiCTR2000039715) of COVID19 candidate vaccine, i.e., influenza virus vector COVID-19 vaccine for intranasal spray (DelNS1-2019-nCoV-RBD-OPT1) produced by Wantai BioPharm, have been completed in China, demonstrating that the candidate vaccine has good safety and immunogenicity in healthy adults aged 18 years and older. The sponsor plans to conduct an international multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to further determine the efficacy and safety of this candidate vaccine in adults aged 18 years and older.

Phase II/III