A Randomized, Double-blind, Placebo-Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV for Inhalation in Adults 18 Years of Age and Older

CanSino Biologics Inc.1 site in 1 country840 target enrollmentApril 21, 2021

ConditionsCOVID-19

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19
Sponsor: CanSino Biologics Inc.
Enrollment: 840
Locations: 1
Primary Endpoint: Incidence of Adverse Reactions (AR)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 21, 2021

End Date

August 9, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CanSino Biologics Inc.

Responsible Party

Sponsor

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);

Outcomes

Primary Outcomes

Incidence of Adverse Reactions (AR)

Time Frame: 0-14 days after each vaccination

The occurrence of Adverse Reactions (AR) in all groups

Incidence of Serious Adverse Events (SAE)

Time Frame: 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 Outcomes

Seroconversion rate of SARS-CoV-2 neutralizing antibody(28 days after the final vaccination)
Changes in laboratory test indicators(4 days after each vaccination)
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)
Incidence of Adverse Events/Reactions (AE/AR)(Within 0-28 days after each vaccination)
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)
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)
Cellular immune response(Before the first dose, 14 days after the first dose)
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)