Clinical trial
A Randomized, Double-blind, Placebo-Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV for Inhalation in Adults 18 Years of Age and Older
Name
JSVCT092
Description
This study is a randomized, double-blind, placebo-controlled I/II clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation in adults 18 years of Age and Older.
Trial arms
Trial start
2021-04-21
Estimated PCD
2022-07-08
Trial end
2022-08-09
Status
Completed
Phase
Early phase I
Treatment
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo
Arms:
A1a Phase I low 2 doses, A2a Phase I medium 2 doses, A3a Phase I high 2 doses, A4a Phase I combine 2 doses, A5a Phase I single dose, B1a Phase II low 2 doses, B2a Phase II medium 2 doses, B3a Phase II high 2 doses, B4a Phase II combine 2 doses, B6a Phase II Aerogen Solo single dose
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Arms:
A4a Phase I combine 2 doses, B4a Phase II combine 2 doses, B5a Phase II intramuscular single dose, B6b Phase II placebo Aerogen Solo single dose
Placebo for Inhalation
Aerogen Solo
Arms:
A1b Phase I placebo low 2 doses, A2b Phase I placebo medium 2 doses, A3b Phase I placebo high 2 doses, A4b Phase I placebo combine 2 doses, A5b Phase I placebo single dose, B1b Phase II placebo low 2 doses (18-59), B2b Phase II placebo medium 2 doses, B3b Phase II placebo high 2 doses, B4b Phase II placebo combine 2 doses
Placebo
Intramuscular administration
Arms:
A4b Phase I placebo combine 2 doses, B4b Phase II placebo combine 2 doses, B5b Phase II placebo intramuscular single dose
Size
840
Primary endpoint
Incidence of Adverse Reactions (AR)
0-14 days after each vaccination
Incidence of Serious Adverse Events (SAE)
Within the first and final vaccination up until 12 months after the final vaccination
Eligibility criteria
Inclusion Criteria:
* Healthy adults 18 years of age and above at the time of enrollment;
* Able to provide consent to participate in and having signed an Informed Consent Form (ICF);
* Able and willing to complete all the scheduled study procedures during the whole study follow-up period;
* HIV negative;
* No nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, sore throat, etc;
* IgG ang IgM negative for Covid-19;
* Axillary temperature ≤37.0℃;
* No contact history of Covid-19.
Exclusion Criteria:
* Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medications (on-site measurement: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), etc;
* Abnormal laboratory test indicators which investigator decide to be clinically significant; (Only Phase I volunteers)
* Respiratory rate ≥17 per minute;
* Abnormal lung function such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, etc;
* Prior Covid-19 vaccinations;
* Symptoms of upper respiratory track infections;
* Medical or family history of convulsions, epilepsy, encephalopathy, and psychosis disorders;
* History of allergies to any ingredient of Ad5-nCoV, history of serious allergic reactions to any vaccine, history of allergies and immune diseases;
* Acute febrile diseases and infectious diseases;
* Medical history of SARS (SARS-CoV-1);
* Severe chronic diseases or with advanced stage conditions which cannot be controlled smoothly, such as diabetes, thyroid disease, etc;
* Congenital or acquired angioedema/neurological edema;
* Urticaria history within 1 year before receiving the study vaccine;
* Asplenia or functional asplenia;
* Thrombocytopenia or other coagulation disorders (may cause contraindications for intramuscular injection);
* Trypanophobia in intramuscular injection groups;
* History of receiving immunosuppressant therapy (continuous oral or instillation for more than 14 days), anti-allergic therapy, cytotoxic therapy, nebulized corticosteroid therapy in the past 6 months;
* Prior administration of blood products in last 4 months;
* Other vaccination(s) or investigational drugs within 1 month before study onset, or planned use during the study period;
* Prior administration of live attenuated vaccine within 1 month before study onset;
* Prior administration of subunit or inactivated vaccine within 14 days before study onset;
* Current anti-tuberculosis therapy;
* Women who are pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the whole study;
* Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives or informed consent (i.e. medical, psychological, social or other conditions, etc.) Exclusion criteria for the phase II portion of the study will be detailed in an amended synopsis/study protocol.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 840, 'type': 'ACTUAL'}}
Updated at
2023-02-08
1 organization
3 products
1 indication
Organization
CanSino BiologicsIndication
COVID-19Product
Placebo