Status:
UNKNOWN
Safety and Immunity of Covid-19 aAPC Vaccine
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Collaborating Sponsors:
Shenzhen Third People's Hospital
Shenzhen Second People's Hospital
Conditions:
Treat and Prevent Covid-19 Infection
Eligibility:
All Genders
6-80 years
Phase:
PHASE1
Brief Summary
In December 2019, viral pneumonia (Covid-19) caused by a novel beta-coronavirus (SARS-CoV-2) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure a...
Detailed Description
Background: The 2019 discovered new coronavirus, SARS-CoV-2, is an enveloped positive strand single strand RNA virus. The number of SARS-CoV-2 infected people has increased rapidly and WHO has warned...
Eligibility Criteria
Inclusion
- Healthy and Covid-19-positive volunteers
- The interval between the onset of symptoms and randomized is within 7 days in Covid-19 patients. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
- White blood cells ≥ 3,500/μl, lymphocytes ≥ 750/μl;
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test negative;
- Sign the Informed Consent voluntarily;
Exclusion
- Subject with active HCV, HBV or HIV infection.
- Subject is albumin-intolerant.
- Subject with life expectancy less than 4 weeks.
- Subject participated in other investigational vaccine therapies within the past 60 days.
- Subject with positive pregnancy test result.
- Researchers consider unsuitable.
Key Trial Info
Start Date :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04299724
Start Date
February 15 2020
End Date
December 31 2024
Last Update
March 9 2020
Active Locations (1)
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1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000