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

Study Overview
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Brief Summary
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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) .

Detailed Description
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose Group<br>Subjects received one dose of 5E10 vp Ad5-nCoV at 18 to 60 years old | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)<br>* Intramuscular other name:Ad5-nCoV<br>|
| Experimental: Middle-dose Group<br>Subjects received one dose of 1E11 vp Ad5-nCoV at 18 to 60 years old | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)<br>* Intramuscular other name:Ad5-nCoV<br>|
| Experimental: High-dose Group<br>Subjects received one dose of 1.5E11vp Ad5-nCoV at 18 to 60 years old | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)<br>* Intramuscular other name:Ad5-nCoV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety indexes of adverse reactions | Occurrence of adverse reactions post-vaccination | 0-7 days post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety indexes of adverse events | Occurrence of adverse events post-vaccination | 0-28 days post-vaccination | 
| Safety indexes of SAE | Occurrence of serious adverse events post-vaccination | 0-28 days, within 6 mouths post-vaccination | 
| Safety indexes of lab measures | Occurrence of abnormal changes of laboratory safety examinations | pre-vaccination, day 7 post-vaccination | 
| Immunogencity indexes of GMT(ELISA) | Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum | day14,28，month 3,6 post-vaccination | 
| Immunogencity indexes of GMT(pseudoviral neutralization test method) | Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum | day14,28，month 6 post-vaccination | 
| Immunogencity indexes of seropositivity rates(ELISA) | the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum | day14,28，month 3,6 post-vaccination | 
| Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) | the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum | day14,28，month 6 post-vaccination | 
| Immunogencity indexes of GMI(ELISA) | Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum | day14,28，month 3,6 post-vaccination | 
| Immunogencity indexes of GMI(pseudoviral neutralization test method) | Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum | day14,28，month 6 post-vaccination | 
| Immunogencity indexes of GMC(Ad5 vector) | Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses | day、14,28，month3,6 post-vaccination | 
| Immunogencity indexes of GMI(Ad5 vector) | Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses | day、14,28，month3,6 post-vaccination | 
| Immunogencity indexes of cellular immune | specific cellular immune responses | day 14, 28,month 6 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, vaccine, Ad5, Safety, Immunogenicity, Infection, novel coronavirus, Dose-escalation