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A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04552366
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 23, 2020
Sponsor:
Collaborator:
Zhongnan Hospital
Information provided by (Responsible Party):
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 17, 2020
Last Update Posted Date September 23, 2020
Estimated Study Start Date  ICMJE September 29, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
  • Incidence of the AE in all groups [ Time Frame: 0-7 days after each vaccination ]
    The occurrence of AE in all groups within 0-7 days after each vaccination;
  • Seroconversion rate of the IgG antibody against SARS-CoV-2 [ Time Frame: Day 28 after last vaccination ]
    Seroconversion rate the IgG antibody against SARS-CoV-2 measured on Day 28 after last vaccination
  • Geomean titers of the IgG antibody against SARS-CoV-2 [ Time Frame: Day 28 after last vaccination ]
    Geomean titers of the IgG antibody against SARS-CoV-2 measured on Day 28 after last vaccination
  • Seroconversion rate of the neutralizing antibody against SARS-CoV-2 [ Time Frame: Day 28 after last vaccination ]
    Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 28 after last vaccination
  • Geomean titers of the neutralizing antibody against SARS-CoV-2 [ Time Frame: Day 28 after last vaccination ]
    Geomean titers of the neutralizing antibody against SARS-CoV-2 measured on Day 28 after last vaccination
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
  • Incidence of the AE in all groups [ Time Frame: 0-30 minutes, 0-28 days after each vaccination ]
    The occurrence of AE in all groups within 0-30 minutes and 0-28 days after each vaccination.
  • Incidence of Serious adverse events (SAE) in all groups [ Time Frame: 6 months after the final vaccination ]
    The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.
  • Geomean titers of the IgG antibody against SARS-CoV-2 [ Time Frame: Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination. ]
    Geomean titers of the IgG antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.
  • Seroconversion rate of the IgG antibody against SARS-CoV-2 [ Time Frame: Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination. ]
    Seroconversion rate of the IgG antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.
  • Geomean titers of the neutralizing antibody against SARS-CoV-2 [ Time Frame: Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination. ]
    Geomean titers of the neutralizing antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.
  • Seroconversion rate of the neutralizing antibody against SARS-CoV-2 [ Time Frame: Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination. ]
    Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 0, Day14, Day 28 or Day 56 after first vaccination and on day 14, day 28 and day168 after last vaccination.
  • Cellular immune response by ELISpot [ Time Frame: Day 0 and Day 14 after each vaccination ]
    The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot on Day 0 and Day 14 after each vaccination
  • Geomean titers of neutralizing antibody response to Ad5-vector [ Time Frame: Day 0, 14 and 28 after each vaccination. ]
    Geomean titers of neutralizing antibody response to Ad5-vector on Day 0, 14 and 28 after each vaccination.
  • Cellular immune response by ICS [ Time Frame: Day 0 and Day 14 after each vaccination ]
    The positive rate of the specific cytokines expressed by CD4+ and CD8+ T lymphocytes stimulated by S protein overlapping peptide library detected by intracellular cytokine staining on Day 0 and Day 14 after each vaccination
  • Geomean titers of the IgA antibody against SARS-CoV-2 [ Time Frame: Day 0, 14 and 28 after each vaccination ]
    Geomean titers of the IgA antibody against SARS-CoV-2 on Day 0, 14 and 28 after each vaccination.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults
Official Title  ICMJE A Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults Aged 18 Years and Older
Brief Summary This is a clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years and older.
Detailed Description A total of 168 healthy adult volunteers will be vaccinated in this clinical trial according to open, partly randomized design from the healthy adults aged 18 years and older. The safety and immunogenicity of intramuscular vaccination and mucosal vaccination of two doses of Ad5-nCoV in different administration schedules will be evaluated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE Biological: Ad5-nCoV
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Study Arms  ICMJE
  • Experimental: Group A: Intramuscular administration
    24 subjects. 5E10 VP of Ad5-nCoV on Day 0 and on Day 56.
    Intervention: Biological: Ad5-nCoV
  • Experimental: Group B: Mixed administration
    24 subjects. An intramuscular administration of 5E10 VP of Ad5-nCoV on day 0 and a mucosal administration of 2E10 VP on Day 28.
    Intervention: Biological: Ad5-nCoV
  • Experimental: Group C: Mucosal administration, high dose
    24 subjects. A mucosal administration of 2E10 VP of Ad5-nCoV on Day 0 and Day 28.
    Intervention: Biological: Ad5-nCoV
  • Experimental: Group D: Mucosal administration, low dose
    24 subjects. A mucosal administration of 1E10 VP of Ad5-nCoV on day 0 and Day 28.
    Intervention: Biological: Ad5-nCoV
  • Active Comparator: Group E: Intramuscular administration, one dose
    24 subjects. An intramuscular administration of 5E10 VP of Ad5-nCoV on day 0.
    Intervention: Biological: Ad5-nCoV
  • Experimental: Group F: Intramuscular administration, two doses
    24 subjects. Two intramuscular administrations of 5E10 VP of Ad5-nCoV at left and right arms on day 0.
    Intervention: Biological: Ad5-nCoV
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: September 20, 2020)
144
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2020)
168
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 years and older;
  • 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 (about 6-8 months, depending on group);
  • Negative result of HIV screening;
  • Axillary temperature ≤37.0°C.
  • Negative IgG and IgM antibodies against COVID-19;
  • Good general health status, as determined by history and physical examination.

Exclusion Criteria for the first vaccination:

  • Hematological examination is abnormal, or clinically significant as assessed by the study investigator (including white blood cell count, lymphocyte count, neutrophil count, eosinophil count, platelet, hemoglobin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood glucose and creatinine);
  • With oral ulcers, throat swelling and other oral diseases.
  • With symptoms of upper respiratory tract infection.
  • Personal history of seizure disorder, encephalopathy or psychosis;
  • Allergic history to any vaccine, or allergic to any ingredient of the Ad5-nCoV;
  • Any acute febrile disease or active infectious disease on the day of vaccination;
  • History of SARS or COVID-19;
  • History of COVID-19 candidate vaccine administration;
  • History of chronic obstructive pulmonary disease (COPD).
  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension not controlled with medication;
  • Serious chronic disease or in the advanced stage that cannot be controlled well, such as asthma, diabetes and thyroid disease, etc.;
  • Congenital or acquired angioedema;
  • Suffered from urticaria within 1 year before receiving the trial vaccine.
  • Asplenia or functional asplenia;
  • Platelet disorder or other bleeding disorder that may cause intramuscular injection contraindication;
  • Faint with needles in intramuscular administration group;
  • Immunosuppressive medication, anti-allergic, cytotoxic therapy, inhaled corticosteroids (excluding surface corticosteroid therapy for acute non-complicated dermatitis) in the last 6 months;
  • Prior administration of blood products in last 4 months;
  • Other vaccination(s) or investigational drugs within 1 month before study onset;
  • 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;
  • Woman is pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the next 8 months;
  • 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 second vaccination:

  • Severe allergic reaction after the first dose of vaccination;
  • Severe adverse reactions causally related to the first vaccination;
  • For those newly discovered or newly occured after the first vaccination that does not meet the first-dose selection criteria or meets the first-dose exclusion criteria, the investigator will determine whether to continue participating in the study;
  • Other reasons for exclusion as deemed by the investigator.
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: Lihua Hou, PhD 861066948565 houlihua@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04552366
Other Study ID Numbers  ICMJE AMMS85-2004
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 Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Study Sponsor  ICMJE Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Collaborators  ICMJE Zhongnan Hospital
Investigators  ICMJE Not Provided
PRS Account Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Verification Date September 2020

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