Phase I/II Clinical Trial of Recombinant Novel Coronavirus (COVID-19) Vaccine (Adenovirus Type 5 Vector) for Inhalation
Phase 1
Completed
- Conditions
- COVID-19
- Interventions
- Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationBiological: Placebo for InhalationBiological: PlaceboBiological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
- Registration Number
- NCT04840992
- Lead Sponsor
- CanSino Biologics Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 840
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B4b Phase II placebo combine 2 doses Placebo Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart B5b Phase II placebo intramuscular single dose Placebo placebo containing 0 vp, 1 dose Intramuscular Injection B4a Phase II combine 2 doses Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation 1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart B2a Phase II medium 2 doses Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo B3a Phase II high 2 doses Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo B4a Phase II combine 2 doses Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart A4b Phase I placebo combine 2 doses Placebo for Inhalation 6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart A4b Phase I placebo combine 2 doses Placebo 6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart B4b Phase II placebo combine 2 doses Placebo for Inhalation Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart B6b Phase II placebo Aerogen Solo single dose Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) placebo containing 0 vp, 1 dose Aerogen Solo B2b Phase II placebo medium 2 doses Placebo for Inhalation Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo A2a Phase I medium 2 doses Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo A4a Phase I combine 2 doses Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation 1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart A1a Phase I low 2 doses Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo A1b Phase I placebo low 2 doses Placebo for Inhalation Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo A3a Phase I high 2 doses Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo A3b Phase I placebo high 2 doses Placebo for Inhalation Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo A5b Phase I placebo single dose Placebo for Inhalation 6 subjects, Placebo containing 0 vp, 1 dose Aerogen Solo B1b Phase II placebo low 2 doses (18-59) Placebo for Inhalation Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo A2b Phase I placebo medium 2 doses Placebo for Inhalation Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo A4a Phase I combine 2 doses Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart A5a Phase I single dose Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo B3b Phase II placebo high 2 doses Placebo for Inhalation Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo B5a Phase II intramuscular single dose Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Ad5-nCoV containing 5E10 vp, 1 dose Intramuscular Injection B6a Phase II Aerogen Solo single dose Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo B1a Phase II low 2 doses Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
- Primary Outcome Measures
Name Time Method Incidence of Adverse Reactions (AR) 0-14 days after each vaccination The occurrence of Adverse Reactions (AR) in all groups
Incidence of Serious Adverse Events (SAE) Within the first and final vaccination up until 12 months after the final vaccination The occurrence of Serious Adverse Events (SAE) in all groups
- Secondary Outcome Measures
Name Time Method Seroconversion rate of SARS-CoV-2 neutralizing antibody 28 days after the final vaccination Changes in laboratory test indicators 4 days after each vaccination Changes in laboratory test indicators (including white blood cell count, lymphocyte count, etc), and respiratory rate in all groups
Seroconversion rate of Covid-19 S protein RBD specific antibody Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose Seroconversion rate of S protein RBD specific antibody by ELISA
Incidence of Adverse Events/Reactions (AE/AR) Within 0-28 days after each vaccination The occurence of Adverse Events/Reactions (AE/AR) in all groups
GMT of Covid-19 S protein RBD specific antibody Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose GMT of S protein RBD specific antibody by ELISA
GMI of Covid-19 S protein RBD specific antibody Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose GMI of S protein RBD specific antibody by ELISA
Cellular immune response Before the first dose, 14 days after the first dose The positive rate of IL-13 stimulated by S protein ELISpot
GMT of SARS-CoV-2 neutralizing antibody 28 days after the final vaccination GMI of SARS-CoV-2 neutralizing antibody Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose GMI of SARS-CoV-2 neutralizing antibody against pseudovirus
Trial Locations
- Locations (1)
Jiangsu Provincal Center for Disease Control and Prevention
🇨🇳Nanjing, Jiangsu, China