Phase I/II Clinical Trial of Recombinant Novel Coronavirus (COVID-19) Vaccine (Adenovirus Type 5 Vector) for Inhalation

CanSino Biologics

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Biological: Placebo for Inhalation; Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation; Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector); Biological: Placebo

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT04840992

JSVCT092

Details and patient eligibility

About

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.

Enrollment: 840 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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840 participants in 22 patient groups, including a placebo group

A1a Phase I low 2 doses

Experimental group

Description:

Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

A1b Phase I placebo low 2 doses

Placebo Comparator group

Description:

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Placebo for Inhalation

A2a Phase I medium 2 doses

Experimental group

Description:

Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

A2b Phase I placebo medium 2 doses

Placebo Comparator group

Description:

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Placebo for Inhalation

A3a Phase I high 2 doses

Experimental group

Description:

Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

A3b Phase I placebo high 2 doses

Placebo Comparator group

Description:

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Placebo for Inhalation

A4a Phase I combine 2 doses

Experimental group

Description:

1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

A4b Phase I placebo combine 2 doses

Placebo Comparator group

Description:

6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart

Treatment:

Biological: Placebo

Biological: Placebo for Inhalation

A5a Phase I single dose

Experimental group

Description:

Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

A5b Phase I placebo single dose

Placebo Comparator group

Description:

6 subjects, Placebo containing 0 vp, 1 dose Aerogen Solo

Treatment:

Biological: Placebo for Inhalation

B1a Phase II low 2 doses

Experimental group

Description:

Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

B1b Phase II placebo low 2 doses (18-59)

Placebo Comparator group

Description:

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Placebo for Inhalation

B2a Phase II medium 2 doses

Experimental group

Description:

Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

B2b Phase II placebo medium 2 doses

Placebo Comparator group

Description:

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Placebo for Inhalation

B3a Phase II high 2 doses

Experimental group

Description:

Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

B3b Phase II placebo high 2 doses

Placebo Comparator group

Description:

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Treatment:

Biological: Placebo for Inhalation

B4a Phase II combine 2 doses

Experimental group

Description:

1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

B4b Phase II placebo combine 2 doses

Placebo Comparator group

Description:

Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart

Treatment:

Biological: Placebo

Biological: Placebo for Inhalation

B5a Phase II intramuscular single dose

Experimental group

Description:

Ad5-nCoV containing 5E10 vp, 1 dose Intramuscular Injection

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

B5b Phase II placebo intramuscular single dose

Placebo Comparator group

Description:

placebo containing 0 vp, 1 dose Intramuscular Injection

Treatment:

Biological: Placebo

B6a Phase II Aerogen Solo single dose

Experimental group

Description:

Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

B6b Phase II placebo Aerogen Solo single dose

Placebo Comparator group

Description:

placebo containing 0 vp, 1 dose Aerogen Solo

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)