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
| Registry | NCT04341389, acronym CTII-nCoV |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, crossover, masking: double, prevention |
| Enrollment | 508 (Actual) |
| Sponsor | Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China (Other); collaborators: CanSino Biologics Inc., Jiangsu Province Centers for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Zhongnan Hospital |
| Conditions | COVID-19 |
| Interventions | Recombinant novel coronavirus vaccine (Adenovirus type 5 vector), Placebo (Biological, other) |
| Dates | start 2020-04-12, primary completion 2020-11-30, completion 2020-12-31, first posted 2020-04-10, last updated 2023-05-24 |
| Locations | 1 site in China |
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All trials for COVID-19 All trials of Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) All trials of Placebo
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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1 | Active comparator | Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) | 1×10\^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0 |
| Arm 2 | Active comparator | Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) | 5×10\^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0 |
| Arm 3 | Placebo comparator | Other: Placebo | Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0 |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Hubei Provincial Center for Disease Control and Prevention | Wuhan, Hubei | China |