Safety and Immunity of Covid-19 aAPC Vaccine
21 augusti 2026 uppdaterad av: Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute
Safety and Immunity Evaluation of A Covid-19 Coronavirus Artificial Antigen Presenting Cell Vaccine
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 and died, making it imperative to develop a safe and effective vaccine to treat and prevent severe Covid-19 pneumonia.
Based on detailed analysis of the viral genome and search for potential immunogenic targets, a synthetic minigene has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease.
The infection of Covid-19 is mediated through binding of the Spike protein to the ACEII receptor, and the viral replication depends on molecular mechanisms of all of these viral proteins.
This trial proposes to develop universal vaccine and test innovative Covid-19 minigenes engineered based on multiple viral genes, using an efficient lentiviral vector system (NHP/TYF) to express viral proteins and immune modulatory genes to modify artificial antigen presenting cells (aAPC) and to activate T cells.
In this study, the safety and immune reactivity of this aAPC vaccine will be investigated.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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 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.
Objective:
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.
Design:
- 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.
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Guangdong
-
Shenzhen, Guangdong, Kina, 518000
- Shenzhen Geno-immune Medical Institute
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
6 månader till 80 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- 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 Criteria:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Injection of Covid-19/aAPC vaccine
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The subjects will receive three injections of 5x10^6 each Covid-19/aAPC vaccine via subcutaneous injections.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Frequency of vaccine events
Tidsram: Measured from Day 0 through Day 28
|
Frequency of vaccine events such as fever, rash, and abnormal heart function.
|
Measured from Day 0 through Day 28
|
|
Frequency of serious vaccine events
Tidsram: Measured from Day 0 through Day 28
|
Frequency of serious vaccine events
|
Measured from Day 0 through Day 28
|
|
Proportion of subjects with positive T cell response
Tidsram: 14 and 28 days after randomization
|
14 and 28 days after randomization
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
28 dagars dödlighet
Tidsram: Mätt från dag 0 till dag 28
|
Antal dödsfall under studieuppföljning
|
Mätt från dag 0 till dag 28
|
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Duration of mechanical ventilation if applicable
Tidsram: Measured from Day 0 through Day 28
|
Duration of mechanical ventilation use in days.
Multiple mechanical ventilation durations are summed up
|
Measured from Day 0 through Day 28
|
|
Proportion of patients in each category of the 7-point scale
Tidsram: 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)
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7,14 and 28 days after randomization
|
|
Proportion of patients with normalized inflammation factors
Tidsram: 7 and 14 days after randomization
|
Proportion of patients with different inflammation factors in normalization range
|
7 and 14 days after randomization
|
|
Clinical improvement based on the 7-point scale if applicable
Tidsram: 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)
|
28 days after randomization
|
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Lower Murray lung injury score if applicable
Tidsram: 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
|
7 days after randomization
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Lung-Ji Chang, Shenzhen Geno-immune Medical Institute
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2026
Primärt slutförande (Faktisk)
1 juli 2026
Avslutad studie (Faktisk)
31 juli 2026
Studieregistreringsdatum
Först inskickad
5 mars 2020
Först inskickad som uppfyllde QC-kriterierna
6 mars 2020
Första postat (Faktisk)
9 mars 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GIMI-IRB-20002
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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