COVID-19
Conditions
Keywords
COVID-19, Vaccine, Ad5, Safety, Immunogenicity, SARS-CoV-2, Adenovirus Vector, Aerogen Solo
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.
Interventions
BIOLOGICALRecombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo
Intramuscular administration
BIOLOGICALPlacebo for Inhalation
Aerogen Solo
BIOLOGICALPlacebo
Intramuscular administration
Sponsors
Beijing Institute of Biotechnology
Jiangsu Province Centers for Disease Control and Prevention
CanSino Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Incidence of Adverse Events/Reactions (AE/AR) | Within 0-7 days after each vaccination | The occurence of Adverse Events/Reactions (AE/AR) in all groups |
| Seroconversion rate 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 | Seroconversion rate of SARS-CoV-2 neutralizing antibody against pseudovirus |
| 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 |
| Cellular immune response | Before the first dose, 14 days after the first dose | The positive rate of IFN-γ stimulated by S protein ELISpot |
| GMT 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 | GMT of SARS-CoV-2 neutralizing antibody against pseudovirus |
| 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 |
Countries
China
Outcome results
None listed