Status:
COMPLETED
Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults
Lead Sponsor:
CanSino Biologics Inc.
Collaborating Sponsors:
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
COVID-19
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed...
Detailed Description
This is a single-center,open-label，dose-escalating phase I clinical trial in healthy 18 to 60 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is ...
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.
- Normal in lung CT images (no imaging features of COVID-19
- Axillary temperature ≤37.0°C.
- The BMI index is 18.5-30.0.
- Negative in Nasopharyngeal swabs / sputum and anal swabs through RT-PCR
- Laboratory tests such as hematological examination and clinical biochemistry examination are in the normal range or without meaning judged by clinical doctor.
- 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 :
March 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04313127
Start Date
March 16 2020
End Date
February 20 2021
Last Update
August 4 2021
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