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

Phase 1

Completed

• Conditions: COVID-19

• 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

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-12
• Study Start: 2021-04-21
• Primary Completion: 2022-07-08
• Study Completion: 2022-08-09
• Status Verified: 2022-10
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

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

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