Safety and Immunity of Covid-19 aAPC Vaccine
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|ClinicalTrials.gov Identifier: NCT04299724|
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : March 9, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Treat and Prevent Covid-19 Infection||Biological: Pathogen-specific aAPC||Phase 1|
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 that the pandemic spread of Covid-19 is imminent and would have disastrous outcomes. Covid-19 could pose a serious threat to human health and the global economy. There is no vaccine available or clinically approved antiviral therapy as yet. This study aims to evaluate the safety and immune reactivity of a genetically modified aAPC universal vaccine to treat and prevent Covid-19.
Primary study objectives: Injection of Covid-19/aAPC vaccine to volunteers to evaluate the safety.
Secondary study objectives: To evaluate the anti- Covid-19 reactivity of the Covid-19/aAPC vaccine.
- Based on the genomic sequence of the new coronavirus SARS-CoV-2, select conserved and critical structural and protease protein domains to engineer lentiviral minigenes to express SARS-CoV-2 antigens.
- The Covid-19/aAPC vaccine is prepared by applying lentivirus modification including immune modulatory genes and the viral minigenes, to the artificial antigen presenting cells (aAPCs). The Covid-19/aAPCs are then inactivated for proliferation and extensively safety tested.
- The subjects receive a total of 5x10^ 6 cells each time by subcutaneous injection at 0, 14 and 28 days. The subjects are followed-up with peripheral blood tests at 0, 14, 21, 28 and 60 days until the end of the test.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Immunity Evaluation of A Covid-19 Coronavirus Artificial Antigen Presenting Cell Vaccine|
|Actual Study Start Date :||February 15, 2020|
|Estimated Primary Completion Date :||July 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
|Experimental: Injection of Covid-19/aAPC vaccine||
Biological: Pathogen-specific aAPC
The subjects will receive three injections of 5x10^6 each Covid-19/aAPC vaccine via subcutaneous injections.
- Frequency of vaccine events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of vaccine events such as fever, rash, and abnormal heart function.
- Frequency of serious vaccine events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of serious vaccine events
- Proportion of subjects with positive T cell response [ Time Frame: 14 and 28 days after randomization ]
- 28-day mortality [ Time Frame: Measured from Day 0 through Day 28 ]Number of deaths during study follow-up
- Duration of mechanical ventilation if applicable [ Time Frame: Measured from Day 0 through Day 28 ]Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up
- Proportion of patients in each category of the 7-point scale [ Time Frame: 7,14 and 28 days after randomization ]Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death)
- Proportion of patients with normalized inflammation factors [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with different inflammation factors in normalization range
- Clinical improvement based on the 7-point scale if applicable [ Time Frame: 28 days after randomization ]A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death)
- Lower Murray lung injury score if applicable [ Time Frame: 7 days after randomization ]Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||6 Months to 80 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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;
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299724
|Contact: Lung-Ji Chang||+86(755)8672 firstname.lastname@example.org|
|Shenzhen Geno-immune Medical Institute||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Contact: Lung-Ji Chang 86-755-86725195 email@example.com|
|Principal Investigator:||Lung-Ji Chang||Shenzhen Geno-Immune Medical Institute|
|Responsible Party:||Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute|
|Other Study ID Numbers:||
|First Posted:||March 9, 2020 Key Record Dates|
|Last Update Posted:||March 9, 2020|
|Last Verified:||March 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Lentiviral vector, Covid-19/aAPC vaccine
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases