NCT04341389CompletedPhase 2
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
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China1 site in 1 country508 target enrollmentStarted: April 12, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 508
- Locations
- 1
- Primary Endpoint
- Anti SARS-CoV-2 S IgG antibody response(ELISA)
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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.
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)
Investigators
Study Sites (1)
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