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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
- Enrollment
- 508
- Locations
- 1
- Primary Endpoint
- Anti SARS-CoV-2 S IgG antibody response(ELISA)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility 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-
- •Axillary temperature ≤37.0°C.
- •The BMI index is 18.5-30.
- •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.
Outcomes
Primary Outcomes
Anti SARS-CoV-2 S IgG antibody response(ELISA)
Time Frame: 28 days post vaccination
Neutralizing antibody response to SARS-CoV-2
Time Frame: 28 days post vaccination
Occurrence of adverse reactions
Time Frame: 0-14 days post vaccination
Secondary Outcomes
- Neutralizing antibody response to SARS-CoV-2(0 and 6 months post vaccination)
- 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 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)