A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)

Study Overview
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Brief Summary
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This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.

Detailed Description
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This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age,inclusive, who meet all eligibility criteria. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. 500 subjects will be enrolled, 250 subjects in middle-dose vaccine group, 125 subjects in low-dose and placebo group, respectively. Immunogenicity will be tested on days 0, 14, 28 and 6 months after vaccination

Official Title
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A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
* Other: Placebo


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. Axillary temperature ≤37.0°C. The BMI index is 18.5-30.0. 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

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>1×10^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0 | Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)<br>* Intramuscular injection<br>* Other names: Ad5-nCoV;|
| Active Comparator: Arm 2<br>5×10^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0 | Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)<br>* Intramuscular injection<br>* Other names: Ad5-nCoV;|
| Placebo Comparator: Arm 3<br>Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0 | Other: Placebo<br>* Intramuscular injection<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse reactions |  | 0-14 days post vaccination | 
| Anti SARS-CoV-2 S IgG antibody response(ELISA) |  | 28 days post vaccination | 
| Neutralizing antibody response to SARS-CoV-2 |  | 28 days post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | 0-28 days post vaccination | 
| Occurrence of serious adverse reaction |  | 0-6 months post vaccination | 
| Anti SARS-CoV-2 S IgG antibody response(ELISA) |  | 0, 14 days and 6 months post vaccination | 
| Neutralizing antibody response to SARS-CoV-2 |  | 0 and 6 months post vaccination | 
| Neutralizing antibody response to Ad5-vector |  | 0, 28 days and 6 months post vaccination | 
| IFN-γ ELISpot responses to SARS-CoV-2 spike protein |  | 0 and 28 days 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-nCoV, SARS-CoV-2