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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840992
• Other study ID #: JSVCT092
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 21, 2021
• Est. completion date: August 9, 2022

Study information

• Verified date: October 2022
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: August 9, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo
• Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
• Placebo for Inhalation
Aerogen Solo
• Placebo
Intramuscular administration

Locations

Country	Name	City	State
China	Jiangsu Provincal Center for Disease Control and Prevention	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Beijing Institute of Biotechnology, Jiangsu Province Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Reactions (AR)	The occurrence of Adverse Reactions (AR) in all groups	0-14 days after each vaccination
Primary	Incidence of Serious Adverse Events (SAE)	The occurrence of Serious Adverse Events (SAE) in all groups	Within the first and final vaccination up until 12 months after the final vaccination
Secondary	Incidence of Adverse Events/Reactions (AE/AR)	The occurence of Adverse Events/Reactions (AE/AR) in all groups	Within 0-7 days after each vaccination
Secondary	Incidence of Adverse Events/Reactions (AE/AR)	The occurence of Adverse Events/Reactions (AE/AR) in all groups	Within 0-28 days after each vaccination
Secondary	Changes in laboratory test indicators	Changes in laboratory test indicators (including white blood cell count, lymphocyte count, etc), and respiratory rate in all groups	4 days after each vaccination
Secondary	GMT of Covid-19 S protein RBD specific antibody	GMT of S protein RBD specific antibody by ELISA	Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
Secondary	Seroconversion rate of Covid-19 S protein RBD specific antibody	Seroconversion rate of S protein RBD specific antibody by ELISA	Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
Secondary	GMI of Covid-19 S protein RBD specific antibody	GMI of S protein RBD specific antibody by ELISA	Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
Secondary	GMT of SARS-CoV-2 neutralizing antibody	GMT of SARS-CoV-2 neutralizing antibody against pseudovirus	Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
Secondary	Seroconversion rate of SARS-CoV-2 neutralizing antibody	Seroconversion rate of SARS-CoV-2 neutralizing antibody against pseudovirus	Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
Secondary	GMI of SARS-CoV-2 neutralizing antibody	GMI of SARS-CoV-2 neutralizing antibody against pseudovirus	Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
Secondary	GMT of SARS-CoV-2 neutralizing antibody		28 days after the final vaccination
Secondary	Seroconversion rate of SARS-CoV-2 neutralizing antibody		28 days after the final vaccination
Secondary	Cellular immune response	The positive rate of IFN-? stimulated by S protein ELISpot	Before the first dose, 14 days after the first dose
Secondary	Cellular immune response	The positive rate of TNF-a stimulated by S protein ELISpot	Before the first dose, 14 days after the first dose
Secondary	Cellular immune response	The positive rate of IL-5 stimulated by S protein ELISpot	Before the first dose, 14 days after the first dose
Secondary	Cellular immune response	The positive rate of IL-4 stimulated by S protein ELISpot	Before the first dose, 14 days after the first dose
Secondary	Cellular immune response	The positive rate of IL-13 stimulated by S protein ELISpot	Before the first dose, 14 days after the first dose