COVID-19
Conditions
Keywords
COVID-19, Vaccine, Ad5, Safety, Immunogencity, SARS-CoV-2, Adenovirus Vector
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).
Interventions
Intramuscular other name:Ad5-nCoV
BIOLOGICALRecombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV
Sponsors
Beijing Institute of Biotechnology
Jiangsu Province Centers for Disease Control and Prevention
CanSino Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety indexes of adverse reactions | within 14 days post each vaccination | Occurrence of adverse reactions post vaccination |
| Immunogencity indexes of GMT | Day 28 post the second vaccination | Evaluate the Geometric mean titer (GMT) of IgG antibody |
| Immunogencity indexes of neutralizing antibody | Day 28 post the second vaccination | Evaluate the Geometric mean titer (GMT) of neutralizing antibody |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety indexes of SAE | Within 6 months post the second vaccination | Occurrence of serious adverse events post-vaccination |
| Immunogencity indexes of GMT | Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination | Evaluate the Geometric mean titer of IgG antibody |
| Safety indexes of adverse events | Day 0-7,0-14,0-28 post each vaccination | Occurrence of adverse reactions post-vaccination |
| Immunogencity indexes of cellular immune | Day 28 post the first vaccination, pre and day 28 post the second vaccination | Number of cell-mediated immune response against SARS-CoV-2（IL-2） |
| Immunogencity indexes of neutralizing antibody | Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination | Evaluate the Geometric mean titer (GMT) of neutralizing antibody |
| Safety indexes of Hematological examination measures（Hemoglobin, WBC） | pre-vaccination, day 4 post each vaccination | Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group) |
| Safety indexes of Blood routine measures(ALT, AST) | pre-vaccination, day 4 post each vaccination | Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group) |
Countries
China
Outcome results
None listed