A Randomized, Double-blind, Placebo -Controlled Phase IIb Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV in Person 6 Years of Age and Older and Those Who Have Previously Been Vaccinated With Ad5-EBOV
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- CanSino Biologics Inc.
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Safety indexes of adverse reactions
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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 .
Detailed Description
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).
Investigators
Eligibility Criteria
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-
- •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
Outcomes
Primary Outcomes
Safety indexes of adverse reactions
Time Frame: within 14 days post each vaccination
Occurrence of adverse reactions post vaccination
Immunogencity indexes of GMT
Time Frame: Day 28 post the second vaccination
Evaluate the Geometric mean titer (GMT) of IgG antibody
Immunogencity indexes of neutralizing antibody
Time Frame: Day 28 post the second vaccination
Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Secondary Outcomes
- Immunogencity indexes of GMT(Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination)
- Safety indexes of Hematological examination measures（Hemoglobin, WBC）(pre-vaccination, day 4 post each vaccination)
- Safety indexes of SAE(Within 6 months post the second vaccination)
- Safety indexes of Blood routine measures(ALT, AST)(pre-vaccination, day 4 post each vaccination)
- Safety indexes of adverse events(Day 0-7,0-14,0-28 post each vaccination)
- Immunogencity indexes of neutralizing antibody(Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination)
- Immunogencity indexes of cellular immune(Day 28 post the first vaccination, pre and day 28 post the second vaccination)