COVID-19 Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation (Ad5-nCoV-IH) in Adults Aged 18 Years and Above Who Have Received One Dose of Intramuscular Ad5-nCoV
Verified date | November 2021 |
Source | CanSino Biologics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase III clinical trial is an endpoint-driven randomized, double-blind, parallel-controlled, multicenter clinical trial, and around 13,000 subjects aged 18 years and above who have previously received 1 dose of intramuscular Ad5-nCoV will be recruited. Volunteers should have been vaccinated with intramuscular Ad5-nCoV > 56 days prior to enrollment. All subjects will receive 1 dose of investigational vaccine or placebo through nebulized inhalation. The ratio of subjects in the vaccine group and placebo group is 1:1 and the efficacy and safety of the investigational vaccine will be followed up for 52 weeks after vaccination.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 20, 2022 |
Est. primary completion date | April 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult volunteers aged 18 years and above who have received 1 dose of intramuscular Ad5-nCoV > 56 days at the enrollment. - Volunteers who have provided informed consent and signed the informed consent form. - Volunteers who are able and willing to comply with the requirements of the clinical study protocol, and can complete the entire follow-up period of this study. Exclusion Criteria: - Allergic to the active ingredient, any non-active ingredient, or substances used in the manufacturing process, or developed an allergy to similar vaccines in the past. - History of severe anaphylactic reaction to vaccines (e.g., acute anaphylactic reactions, angioedema, dyspnea). - History or family history of seizures, epilepsy, encephalopathy, or psychosis. - Severe nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, throat redness, and swelling. - History of a definite diagnosis of COVID-19. - Positive SARS-CoV-2 N antibody rapid screening kit (IgG and IgM) results. - Received COVID-19 vaccine other than Ad5-nCoV. - Axillary temperature > 37.0°C. - Severe cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, or severe hypertension and cannot be controlled by drugs. - Lung function abnormalities such as asthma, chronic obstructive pulmonary disease, and pulmonary fibrosis. - Acute febrile illness, symptoms of upper respiratory tract infection, or infectious diseases. - Severe chronic diseases, or diseases of the progressive stage that cannot be steadily controlled, such as diabetes or thyroid disorders. - Asplenia or functional asplenia. - Thrombocytopenia or other coagulation disorder. - Received immunosuppressant or immunomodulatory therapy (continuous oral or intravenous infusion for more than 14 days), anti-allergic therapy, cytotoxic therapy within the past 6 months. Inhalational and local steroids are allowed. - Received blood products within 4 months before receiving the investigational vaccine. - Received other vaccines within the past 14 days or plan to receive other vaccines 14 days after scheduled immunization with the investigational vaccine. - Volunteers under antituberculous treatment or with active tuberculosis. - Received blood/plasma products or immunoglobulin 60 days before immunization with the investigational vaccine or planned to receive blood/plasma products or immunoglobulin during the entire study period. - Females who are positive for the urine pregnancy test, pregnant, or breastfeeding, or females who plan to conceive within 3 months (urine pregnancy test will only be performed in female volunteers of childbearing age). - Volunteers who are judged by the investigator with any contradiction to the study protocol or affected the signing of informed consent due to various medical, psychological,social, or other conditions. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
CanSino Biologics Inc. | Beijing Institute of Biotechnology |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of COVID-19 cases. | The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease. | Day 14 to 12 months post vaccination | |
Primary | Incidence of SAE | Evaluate the incidence of severe adverse events (SAE) | Within 12 months post vaccination | |
Secondary | Incidence of COVID-19 cases | The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease. | Day 28 to 12 months post vaccination | |
Secondary | Incidence of severe COVID-19 cases | Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection. | Day 14 and Day 28 to 12 months post vaccination | |
Secondary | Incidence of COVID-19 cases in different age groups | The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease in participants between 18-59 years, and participants aged 60 years and above. | Day 14 and Day 28 to 12 months post vaccination | |
Secondary | Incidence of Adverse Reactions (ARs) | Incidence of ARs within 30 minutes post vaccination in the safety cohort. | Within 30 minutes post vaccination | |
Secondary | Incidence of Adverse Reactions (ARs) | Incidence of ARs within 14 days post vaccination in the safety cohort. | Within 14 days post vaccination | |
Secondary | Incidence of Adverse Events (AEs) | Incidence of AEs within 28 days post vaccination in the safety cohort. | Within 28 days post vaccination | |
Secondary | Immunogenicity of S-RBD IgG antibody (ELISA method) | Seroconversion rate of S-RBD IgG antibody post vaccination. | Day 14, Day 28, Week 24, and Week 52 post-vaccination | |
Secondary | Immunogenicity of S-RBD IgG antibody (ELISA method) | GMT of S-RBD IgG antibody post vaccination. | Day 14, Day 28, Week 24, and Week 52 post-vaccination | |
Secondary | Immunogenicity of S-RBD IgG antibody (ELISA method) | GMI of S-RBD IgG antibody post vaccination. | Day 14, Day 28, Week 24, and Week 52 post-vaccination | |
Secondary | Immunogenicity of neutralizing antibodies | Seroconversion rate of neutralizing antibodies post vaccination. | Day 14, Day 28, Week 24, and Week 52 post-vaccination | |
Secondary | Immunogenicity of neutralizing antibodies | GMT of neutralizing antibodies post vaccination. | Day 14, Day 28, Week 24, and Week 52 post-vaccination | |
Secondary | Immunogenicity of neutralizing antibodies | GMI of neutralizing antibodies post vaccination. | Day 14, Day 28, Week 24, and Week 52 post-vaccination |
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