Status:
COMPLETED
A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)
Lead Sponsor:
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Collaborating Sponsors:
CanSino Biologics Inc.
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 design...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT04341389
Start Date
April 12 2020
End Date
December 31 2020
Last Update
May 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China