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

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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.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Biological: Placebo for Inhalation Biological: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : July 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A1a Phase I low 2 doses
Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo

Placebo Comparator: A1b Phase I placebo low 2 doses
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Placebo for Inhalation
Aerogen Solo

Experimental: A2a Phase I medium 2 doses
Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo

Placebo Comparator: A2b Phase I placebo medium 2 doses
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Placebo for Inhalation
Aerogen Solo

Experimental: A3a Phase I high 2 doses
Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo

Placebo Comparator: A3b Phase I placebo high 2 doses
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Placebo for Inhalation
Aerogen Solo

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

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration

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
Biological: Placebo for Inhalation
Aerogen Solo

Biological: Placebo
Intramuscular administration

Experimental: A5a Phase I single dose
Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo

Placebo Comparator: A5b Phase I placebo single dose
6 subjects, Placebo containing 0 vp, 1 dose Aerogen Solo
Biological: Placebo for Inhalation
Aerogen Solo

Experimental: B1a Phase II low 2 doses
Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo

Placebo Comparator: B1b Phase II placebo low 2 doses (18-59)
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Placebo for Inhalation
Aerogen Solo

Experimental: B2a Phase II medium 2 doses
Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo

Placebo Comparator: B2b Phase II placebo medium 2 doses
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Placebo for Inhalation
Aerogen Solo

Experimental: B3a Phase II high 2 doses
Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo

Placebo Comparator: B3b Phase II placebo high 2 doses
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
Biological: Placebo for Inhalation
Aerogen Solo

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

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration

Placebo Comparator: B4b Phase II placebo combine 2 doses
Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
Biological: Placebo for Inhalation
Aerogen Solo

Biological: Placebo
Intramuscular administration

Experimental: B5a Phase II intramuscular single dose
Ad5-nCoV containing 5E10 vp, 1 dose Intramuscular Injection
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration

Placebo Comparator: B5b Phase II placebo intramuscular single dose
placebo containing 0 vp, 1 dose Intramuscular Injection
Biological: Placebo
Intramuscular administration

Experimental: B6a Phase II Aerogen Solo single dose
Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
Aerogen Solo

Placebo Comparator: B6b Phase II placebo Aerogen Solo single dose
placebo containing 0 vp, 1 dose Aerogen Solo
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration




Primary Outcome Measures :
  1. Incidence of Adverse Reactions (AR) [ Time Frame: 0-14 days after each vaccination ]
    The occurrence of Adverse Reactions (AR) in all groups

  2. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: 28 days after the final vaccination ]
  11. Seroconversion rate of SARS-CoV-2 neutralizing antibody [ Time Frame: 28 days after the final vaccination ]
  12. 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

  13. 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

  14. 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

  15. 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

  16. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840992


Contacts
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Contact: Rong Tang, MSD +86 025-83759911 tangrongtr@126.com

Locations
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China, Jiangsu
Jiangsu Provincal Center for Disease Control and Prevention Recruiting
Nanjing, Jiangsu, China
Contact: Rong Tang, MSD    +86 025-83759911    tangrongtr@126.com   
Sponsors and Collaborators
CanSino Biologics Inc.
Beijing Institute of Biotechnology
Jiangsu Province Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Fengcai Zhu, MSD Jiangsu Provincal Center for Disease Control and Prevention
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Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT04840992    
Other Study ID Numbers: JSVCT092
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CanSino Biologics Inc.:
COVID-19
Vaccine
Ad5
Safety
Immunogenicity
SARS-CoV-2
Adenovirus Vector
Aerogen Solo
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs