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Safety and Immunity of Covid-19 aAPC Vaccine

6. marts 2020 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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:

  1. 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.
  2. 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.
  3. 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Lung-Ji Chang
  • Telefonnummer: +86(755)8672 5195
  • E-mail: c@szgimi.org

Studiesteder

  • Kina
    • Guangdong
      • Shenzhen, Guangdong, Kina, 518000
        • Rekruttering
        • Shenzhen Geno-immune Medical Institute
        • Kontakt:
          • Lung-Ji Chang
          • Telefonnummer: 86-755-86725195
          • E-mail: c@szgimi.org

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder til 80 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Injection of Covid-19/aAPC vaccine
Biologisk: Pathogen-specific aAPC
The subjects will receive three injections of 5x10^6 each Covid-19/aAPC vaccine via subcutaneous injections.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency of vaccine events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 14 and 28 days after randomization
14 and 28 days after randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
28 dages dødelighed
Tidsramme: Målt fra dag 0 til og med dag 28
Antal dødsfald under undersøgelsesopfølgning
Målt fra dag 0 til og med dag 28
Duration of mechanical ventilation if applicable
Tidsramme: 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
Tidsramme: 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)
7,14 and 28 days after randomization
Proportion of patients with normalized inflammation factors
Tidsramme: 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
Tidsramme: 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
Lower Murray lung injury score if applicable
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shenzhen Geno-Immune Medical Institute

Samarbejdspartnere

Shenzhen Second People's Hospital
Shenzhen Third People's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. februar 2020

Primær færdiggørelse (Forventet)

31. juli 2023

Studieafslutning (Forventet)

31. december 2024

Datoer for studieregistrering

Først indsendt

5. marts 2020

Først indsendt, der opfyldte QC-kriterier

6. marts 2020

Først opslået (Faktiske)

9. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GIMI-IRB-20002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Treat and Prevent Covid-19 Infection

Kliniske forsøg med Pathogen-specific aAPC

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