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
Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
Intramuscular injection
Other Name: Ad5-nCoV
Other: Placebo
Intramuscular injection
Other Name: Control
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.
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Fengcai Zhu, MD, Principal Investigator
Jiangsu Province Centers of Disease Control and Prevention