This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .
This is a phase IIb clinical trial to evaluate safety and immuogenicity of Ad5-nCoV developed
by Cansino and Beijing Institute of Biotechnology in health people aged 6 years old and
above.
The study will be double-blind, placebo-controlled trial with participants randomly allocated
2:1 to placebo and experimental vaccine .
The immunization schedule is two doses intramuscular injections (deltoid).
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV
Inclusion Criteria:
- Aged 18 to 55 years old in MID group; aged 6-17 years old in MIN group; aged 56 years
and above in OLD group; aged in EBO group is not limited.
- 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.
- 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.
Taixing City center for Disease Control and Prevention
Taizhou, Jiangsu, China
Fengcai Zhu, MSD, Principal Investigator
Jiangsu Provincal Center for Disease Control and Prevention