Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04840992
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : August 2, 2021
Sponsor:
Collaborators:
Beijing Institute of Biotechnology
Jiangsu Province Centers for Disease Control and Prevention
Information provided by (Responsible Party):
CanSino Biologics Inc.

Tracking Information
First Submitted Date  ICMJE April 8, 2021
First Posted Date  ICMJE April 12, 2021
Last Update Posted Date August 2, 2021
Actual Study Start Date  ICMJE April 20, 2021
Estimated Primary Completion Date April 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2021)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2021)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2021)
  • Incidence of Adverse Events/Reactions (AE/AR) [ Time Frame: Within 0-7 days after each vaccination ]
    The occurence of Adverse Events/Reactions (AE/AR) in all groups
  • Incidence of Adverse Events/Reactions (AE/AR) [ Time Frame: Within 0-28 days after each vaccination ]
    The occurence of Adverse Events/Reactions (AE/AR) in all groups
  • Changes in laboratory test indicators [ Time Frame: 4 days after each vaccination ]
    Changes in laboratory test indicators (including white blood cell count, lymphocyte count, etc), and respiratory rate in all groups
  • GMT of Covid-19 S protein RBD specific antibody [ Time Frame: 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
  • Seroconversion rate of Covid-19 S protein RBD specific antibody [ Time Frame: 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
  • GMI of Covid-19 S protein RBD specific antibody [ Time Frame: 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
  • GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose ]
    GMT of SARS-CoV-2 neutralizing antibody against pseudovirus
  • Seroconversion rate of SARS-CoV-2 neutralizing antibody [ Time Frame: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose ]
    Seroconversion rate of SARS-CoV-2 neutralizing antibody against pseudovirus
  • GMI of SARS-CoV-2 neutralizing antibody [ Time Frame: 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
  • GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: 28 days after the final vaccination ]
  • Seroconversion rate of SARS-CoV-2 neutralizing antibody [ Time Frame: 28 days after the final vaccination ]
  • Cellular immune response [ Time Frame: Before the first dose, 14 days after the first dose ]
    The positive rate of IFN-γ stimulated by S protein ELISpot
  • Cellular immune response [ Time Frame: Before the first dose, 14 days after the first dose ]
    The positive rate of TNF-α stimulated by S protein ELISpot
  • Cellular immune response [ Time Frame: Before the first dose, 14 days after the first dose ]
    The positive rate of IL-5 stimulated by S protein ELISpot
  • Cellular immune response [ Time Frame: Before the first dose, 14 days after the first dose ]
    The positive rate of IL-4 stimulated by S protein ELISpot
  • Cellular immune response [ Time Frame: Before the first dose, 14 days after the first dose ]
    The positive rate of IL-13 stimulated by S protein ELISpot
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2021)
  • Incidence of Adverse Events/Reactions (AE/AR) [ Time Frame: Within 0-7 days after each vaccination ]
    The occurance of Adverse Events/Reactions (AE/AR) in all groups.
  • Incidence of Adverse Events/Reactions (AE/AR) [ Time Frame: Within 0-28 days after each vaccination ]
    The occurance of Adverse Events/Reactions (AE/AR) in all groups.
  • Changes in laboratory test indicators [ Time Frame: 4 days after each vaccination ]
    Changes in laboratory test indicators (including white blood cell count, lymphocyte count, etc), and respiratory rate in all groups.
  • GMT, seroconversion rate and GMI of Covid-19 S protein RBD specific antibody [ Time Frame: Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose ]
    GMT, seroconversion rate and GMI of S protein RBD specific antibody by ELISA in all groups.
  • GMT, seroconversion rate, GMI of neutralizing antibody (pseudovirus) against Covid-19 [ Time Frame: Before the first dose, 28 days after the first dose, bofore the second dose, 14 days after the second dose ]
    GMT, seroconversion rate, GMI of neutralizing antibody (pseudovirus) against Covid-19 in all groups.
  • GMT and seroconversion rate of neutralizing antibody against Covid-19 [ Time Frame: 28 days after the final vaccination ]
    GMT and seroconversion rate of neutralizing antibody against Covid-19 in all goups.
  • Cellular immune response by ELISpot [ Time Frame: Before the first dose, 14 days after the first dose ]
    The positive rate of IFN-γ、TNF-α、IL-5、IL-4、IL-13 by stimulated by S protein ELISpot in all groups.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I/II Clinical Trial of Recombinant Novel Coronavirus (COVID-19) Vaccine (Adenovirus Type 5 Vector) for Inhalation
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
    Aerogen Solo
  • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    Intramuscular administration
  • Biological: Placebo for Inhalation
    Aerogen Solo
  • Biological: Placebo
    Intramuscular administration
Study Arms  ICMJE
  • Experimental: A1a Phase I low 2 doses
    Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
  • Placebo Comparator: A1b Phase I placebo low 2 doses
    Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Placebo for Inhalation
  • Experimental: A2a Phase I medium 2 doses
    Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
  • Placebo Comparator: A2b Phase I placebo medium 2 doses
    Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Placebo for Inhalation
  • Experimental: A3a Phase I high 2 doses
    Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
  • Placebo Comparator: A3b Phase I placebo high 2 doses
    Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Placebo for Inhalation
  • Experimental: 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
    Interventions:
    • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
    • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: A4b Phase I placebo combine 2 doses
    6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
    Interventions:
    • Biological: Placebo for Inhalation
    • Biological: Placebo
  • Experimental: A5a Phase I single dose
    Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
  • Placebo Comparator: A5b Phase I placebo single dose
    6 subjects, Placebo containing 0 vp, 1 dose Aerogen Solo
    Intervention: Biological: Placebo for Inhalation
  • Experimental: B1a Phase II low 2 doses
    Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
  • Placebo Comparator: B1b Phase II placebo low 2 doses (18-59)
    Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Placebo for Inhalation
  • Experimental: B2a Phase II medium 2 doses
    Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
  • Placebo Comparator: B2b Phase II placebo medium 2 doses
    Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Placebo for Inhalation
  • Experimental: B3a Phase II high 2 doses
    Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
  • Placebo Comparator: B3b Phase II placebo high 2 doses
    Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
    Intervention: Biological: Placebo for Inhalation
  • Experimental: 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
    Interventions:
    • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
    • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: B4b Phase II placebo combine 2 doses
    Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
    Interventions:
    • Biological: Placebo for Inhalation
    • Biological: Placebo
  • Experimental: B5a Phase II intramuscular single dose
    Ad5-nCoV containing 5E10 vp, 1 dose Intramuscular Injection
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: B5b Phase II placebo intramuscular single dose
    placebo containing 0 vp, 1 dose Intramuscular Injection
    Intervention: Biological: Placebo
  • Experimental: B6a Phase II Aerogen Solo single dose
    Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
  • Placebo Comparator: B6b Phase II placebo Aerogen Solo single dose
    placebo containing 0 vp, 1 dose Aerogen Solo
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2021)
840
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2022
Estimated Primary Completion Date April 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rong Tang, MSD +86 025-83759911 tangrongtr@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04840992
Other Study ID Numbers  ICMJE JSVCT092
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CanSino Biologics Inc.
Study Sponsor  ICMJE CanSino Biologics Inc.
Collaborators  ICMJE
  • Beijing Institute of Biotechnology
  • Jiangsu Province Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Fengcai Zhu, MSD Jiangsu Provincal Center for Disease Control and Prevention
PRS Account CanSino Biologics Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP