Safety and Immunity of Covid-19 aAPC Vaccine
21. august 2026 oppdatert 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.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
100
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Guangdong
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Shenzhen, Guangdong, Kina, 518000
- Shenzhen Geno-immune Medical Institute
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 måneder til 80 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of vaccine events
Tidsramme: Measured from Day 0 through Day 28
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Frequency of vaccine events such as fever, rash, and abnormal heart function.
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Measured from Day 0 through Day 28
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Frequency of serious vaccine events
Tidsramme: Measured from Day 0 through Day 28
|
Frequency of serious vaccine events
|
Measured from Day 0 through Day 28
|
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Proportion of subjects with positive T cell response
Tidsramme: 14 and 28 days after randomization
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14 and 28 days after randomization
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
28 dagers dødelighet
Tidsramme: Målt fra dag 0 til og med dag 28
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Antall dødsfall under studieoppfølging
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Målt fra dag 0 til og med dag 28
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Duration of mechanical ventilation if applicable
Tidsramme: Measured from Day 0 through Day 28
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Duration of mechanical ventilation use in days.
Multiple mechanical ventilation durations are summed up
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Measured from Day 0 through Day 28
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Proportion of patients in each category of the 7-point scale
Tidsramme: 7,14 and 28 days after randomization
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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
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Proportion of patients with normalized inflammation factors
Tidsramme: 7 and 14 days after randomization
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Proportion of patients with different inflammation factors in normalization range
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7 and 14 days after randomization
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Clinical improvement based on the 7-point scale if applicable
Tidsramme: 28 days after randomization
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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)
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28 days after randomization
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Lower Murray lung injury score if applicable
Tidsramme: 7 days after randomization
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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
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7 days after randomization
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Lung-Ji Chang, Shenzhen Geno-immune Medical Institute
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2026
Primær fullføring (Faktiske)
1. juli 2026
Studiet fullført (Faktiske)
31. juli 2026
Datoer for studieregistrering
Først innsendt
5. mars 2020
Først innsendt som oppfylte QC-kriteriene
6. mars 2020
Først lagt ut (Faktiske)
9. mars 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GIMI-IRB-20002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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