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

NCT ID: NCT04840992

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 840 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2022-08-09

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

A1a Phase I low 2 doses

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Aerogen Solo

A1b Phase I placebo low 2 doses

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

Group Type: PLACEBO_COMPARATOR

Placebo for Inhalation

Intervention Type: BIOLOGICAL

Aerogen Solo

A2a Phase I medium 2 doses

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Aerogen Solo

A2b Phase I placebo medium 2 doses

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

Group Type: PLACEBO_COMPARATOR

Placebo for Inhalation

Intervention Type: BIOLOGICAL

Aerogen Solo

A3a Phase I high 2 doses

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Aerogen Solo

A3b Phase I placebo high 2 doses

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

Group Type: PLACEBO_COMPARATOR

Placebo for Inhalation

Intervention Type: BIOLOGICAL

Aerogen Solo

A4a Phase I combine 2 doses

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Aerogen Solo

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intervention Type: BIOLOGICAL

Intramuscular administration

A4b Phase I placebo combine 2 doses

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

Group Type: PLACEBO_COMPARATOR

Placebo for Inhalation

Intervention Type: BIOLOGICAL

Aerogen Solo

Placebo

Intervention Type: BIOLOGICAL

Intramuscular administration

A5a Phase I single dose

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Aerogen Solo

A5b Phase I placebo single dose

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

Group Type: PLACEBO_COMPARATOR

Placebo for Inhalation

Intervention Type: BIOLOGICAL

Aerogen Solo

B1a Phase II low 2 doses

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Aerogen Solo

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

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

Group Type: PLACEBO_COMPARATOR

Placebo for Inhalation

Intervention Type: BIOLOGICAL

Aerogen Solo

B2a Phase II medium 2 doses

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Aerogen Solo

B2b Phase II placebo medium 2 doses

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

Group Type: PLACEBO_COMPARATOR

Placebo for Inhalation

Intervention Type: BIOLOGICAL

Aerogen Solo

B3a Phase II high 2 doses

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Aerogen Solo

B3b Phase II placebo high 2 doses

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

Group Type: PLACEBO_COMPARATOR

Placebo for Inhalation

Intervention Type: BIOLOGICAL

Aerogen Solo

B4a Phase II combine 2 doses

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Aerogen Solo

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intervention Type: BIOLOGICAL

Intramuscular administration

B4b Phase II placebo combine 2 doses

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

Group Type: PLACEBO_COMPARATOR

Placebo for Inhalation

Intervention Type: BIOLOGICAL

Aerogen Solo

Placebo

Intervention Type: BIOLOGICAL

Intramuscular administration

B5a Phase II intramuscular single dose

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

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intervention Type: BIOLOGICAL

Intramuscular administration

B5b Phase II placebo intramuscular single dose

placebo containing 0 vp, 1 dose Intramuscular Injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Intramuscular administration

B6a Phase II Aerogen Solo single dose

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Aerogen Solo

B6b Phase II placebo Aerogen Solo single dose

placebo containing 0 vp, 1 dose Aerogen Solo

Group Type: PLACEBO_COMPARATOR

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intervention Type: BIOLOGICAL

Intramuscular administration

Interventions

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

Aerogen Solo

Intervention Type: BIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intramuscular administration

Intervention Type: BIOLOGICAL

Placebo for Inhalation

Aerogen Solo

Intervention Type: BIOLOGICAL

Placebo

Intramuscular administration

Intervention Type: BIOLOGICAL

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Institute of Biotechnology

OTHER

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: collaborator

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengcai Zhu, MSD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincal Center for Disease Control and Prevention

Locations

Jiangsu Provincal Center for Disease Control and Prevention

Nanjing, Jiangsu, China

Countries

China

References

Zhu Y, Tang R, Li X, Chen X, Wang X, Wang Y, Wang R, Zhu F, Li J. Vaccination with Adenovirus Type 5 Vector-Based COVID-19 Vaccine as the Primary Series in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Clinical Trial. Vaccines (Basel). 2024 Mar 11;12(3):292. doi: 10.3390/vaccines12030292.

Reference Type: DERIVED

PMID: 38543926 (View on PubMed)

Xia X, Tan ZM, Wan P, Zheng H, Tang R, Chen XQ, Guo XL, Zhu T, Feng JL, Zhong J, Li XL, Zhang ZY, Zhu FC, Li JX. Environmental Impact Assessment for the Use of an Orally Aerosolized Adenovirus Type-5 Vector-Based COVID-19 Vaccine in Randomized Clinical Trials. J Infect Dis. 2023 Sep 15;228(6):715-722. doi: 10.1093/infdis/jiad134.

Reference Type: DERIVED

PMID: 37202147 (View on PubMed)

Other Identifiers

JSVCT092

Identifier Type: -

Identifier Source: org_study_id