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Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults (CTCOVID-19)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04313127
Recruitment Status : Completed
First Posted : March 18, 2020
Last Update Posted : August 4, 2021
Sponsor:
Collaborators:
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Jiangsu Province Centers for Disease Control and Prevention
Hubei Provincial Center for Disease Control and Prevention
Tongji Hospital
Information provided by (Responsible Party):
CanSino Biologics Inc.

Study Description
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Brief Summary:

The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.

In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.

This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .


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

Detailed Description:
This is a single-center,open-label，dose-escalating phase I clinical trial in healthy 18 to 60 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.One hundred and eight subjects will be enrolled into one of three cohorts and will receive an intramuscular (IM) injection of experimental vaccine or placebo on Days 1 in the deltoid muscle.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Single-center,Open-label，Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old
Actual Study Start Date : March 16, 2020
Actual Primary Completion Date : January 20, 2021
Actual Study Completion Date : February 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low-dose Group
Subjects received one dose of 5E10 vp Ad5-nCoV at 18 to 60 years old
 Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV
Experimental: Middle-dose Group
Subjects received one dose of 1E11 vp Ad5-nCoV at 18 to 60 years old
 Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV
Experimental: High-dose Group
Subjects received one dose of 1.5E11vp Ad5-nCoV at 18 to 60 years old
 Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV


Outcome Measures
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Primary Outcome Measures :
  1. Safety indexes of adverse reactions [ Time Frame: 0-7 days post-vaccination ]
    Occurrence of adverse reactions post-vaccination


Secondary Outcome Measures :
  1. Safety indexes of adverse events [ Time Frame: 0-28 days post-vaccination ]
    Occurrence of adverse events post-vaccination

  2. Safety indexes of SAE [ Time Frame: 0-28 days, within 6 mouths post-vaccination ]
    Occurrence of serious adverse events post-vaccination

  3. Safety indexes of lab measures [ Time Frame: pre-vaccination, day 7 post-vaccination ]
    Occurrence of abnormal changes of laboratory safety examinations

  4. Immunogencity indexes of GMT(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]
    Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

  5. Immunogencity indexes of GMT(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]
    Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

  6. Immunogencity indexes of seropositivity rates(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]
    the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

  7. Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]
    the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

  8. Immunogencity indexes of GMI(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]
    Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

  9. Immunogencity indexes of GMI(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]
    Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

  10. Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]
    Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses

  11. Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]
    Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses

  12. Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]
    specific cellular immune responses


Other Outcome Measures:
  1. Consistency analysis(ELISA and pseudoviral neutralization test method) [ Time Frame: day,14,28, month 6 post-vaccination ]
    Consistency analysis of S-specific antibodies against 2019 novel coronavirus tested by ELISA against those tested by pseudoviral neutralization test method

  2. Dose-response relationship（Humoral immunity） [ Time Frame: day14,28，month 3,6 post-vaccination ]
    Relationship between Geometric mean titer (GMT) of S protein-specific antibodies against 2019 novel coronavirus and vaccine dose among study groups

  3. Persistence analysis of anti-S protein antibodies [ Time Frame: day14,28，month 3,6 post-vaccination ]
    Persistence analysis of anti-S protein antibodies among study groups

  4. Time-dose-response relationship（Humoral immunity） [ Time Frame: day14,28，month 3,6 post-vaccination ]
    Relationship between the appearance time of S-specific antibodies against 2019 novel coronavirus and the vaccination dose.

  5. Dose-response relationship（ cellular immunity） [ Time Frame: day 14, 28,month 6 post-vaccination ]
    Relationship between cellular immune levels against 2019 novel coronavirus and vaccine dose among study groups

  6. Persistence analysis of cellular immuse [ Time Frame: day 14, 28,month 6 post-vaccination ]
    Persistence analysis of specific cellular immune response

  7. Time-dose-response relationship（cellular immunity） [ Time Frame: day 14, 28,month 6 post-vaccination ]
    Relationship between the appearance time of cellular immunity against 2019 novel coronavirus and the vaccination dose.


Eligibility Criteria
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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 to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between 18 and 60 years.
  • Able to understand the content of informed consent and willing to sign the informed consent
  • Able and willing to complete all the secluded study process during the whole 6 months study follow-up period.
  • Negative in HIV diagnostic test.
  • Negative in serum antibodies (IgG and IgM) screening of COVID-19.
  • Normal in lung CT images (no imaging features of COVID-19
  • Axillary temperature ≤37.0°C.
  • The BMI index is 18.5-30.0.
  • Negative in Nasopharyngeal swabs / sputum and anal swabs through RT-PCR
  • Laboratory tests such as hematological examination and clinical biochemistry examination are in the normal range or without meaning judged by clinical doctor.
  • General good health as established by medical history and physical examination.

Exclusion Criteria:

  • Family history of seizure, epilepsy, brain or mental disease
  • Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
  • Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
  • Any acute fever disease or infections.
  • History of SARS
  • Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease.
  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
  • Hereditary angioneurotic edema or acquired angioneurotic edema
  • Urticaria in last one year
  • No spleen or functional spleen.
  • Platelet disorder or other bleeding disorder may cause injection contraindication
  • Faint at the sight of needles.
  • Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months.
  • Prior administration of blood products in last 4 months
  • Prior administration of other research medicines in last 1 month
  • Prior administration of attenuated vaccine in last 1 month
  • Prior administration of inactivated vaccine in last 14 days
  • Current anti-tuberculosis prophylaxis or therapy
  • According to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.
Contacts and Locations
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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): NCT04313127


Locations
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China, Hubei
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Sponsors and Collaborators
CanSino Biologics Inc.
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Jiangsu Province Centers for Disease Control and Prevention
Hubei Provincial Center for Disease Control and Prevention
Tongji Hospital
Investigators
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Principal Investigator: Zhu Fengcai Jiangsu Province Centers for Disease Control and Prevention
Principal Investigator: Guan Xuhua Hubei Provincial Center for Disease Control and Prevention
Principal Investigator: Wang Wei Tongji Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT04313127    
Other Study ID Numbers: JSVCT088
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We support data sharing of the individual participant data. The individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendixes) will be shared. Individual participant data will be available beginning 3 months and ending one year following article publication. Supporting clinical documents including study protocol, statistical analysis plan (SAP), and the informed consent form (ICF) will be available immediately following publication for at least one year. Supporting clinical documents access information will be available at http://www.jshealth.com/. Researchers who provide a scientifically sound proposal will be allowed to access to the individual participant data. Proposals should be directed to jszfc@vip.sina.com or cw0226@foxmail.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available beginning 3 months and ending one year following article publication
Access Criteria: Data access requests will be reviewed by the sponsor，investigator and collaborators on the basis of scientific merit. To gain access, data requestors will need to sign a data access agreement.
URL: http://www.jshealth.com/

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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
Infection
novel coronavirus
Dose-escalation
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases