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Therapeutic Vaccine Trial of COVID-19 for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428073
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
GeneCure Biotechnologies

Study Description
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Brief Summary:
GC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed for safety through week 26.

Condition or disease Intervention/treatment Phase
COVID Biological: Covax-19™ Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of a Therapeutic Vaccine (Covax-19™) in SARS-CoV-2 Infected Patients
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose group
Subjects will receive 1.0 mL of low dose vaccine at week 0 and 2.
 Biological: Covax-19™
Therapeutic vaccine for SARS-CoV-2 infection
Experimental: High dose group
Subjects will receive 1.0 mL of high dose vaccine at week 0 and 2.
 Biological: Covax-19™
Therapeutic vaccine for SARS-CoV-2 infection


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities. [ Time Frame: 26 weeks ]
    Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations.


Secondary Outcome Measures :
  1. To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response [ Time Frame: 6 weeks ]
    Magnitude of IFN-γ producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations.

  2. Virologic response after vaccination [ Time Frame: 4 weeks ]
    Detection of SARS-CoV-2 by RT-PCR in respiratory tract specimens at week 0, 1, 2, 3, and 4.

  3. Clinical outcome and progression after vaccinations [ Time Frame: 6 weeks ]
    Number of participants with moderate, severe or critical Covid-19 at week 6.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Documentation of Covid-19 infection based on laboratory evidence of positivity by RT- PCR.
  2. Patients who have no clinical symptoms (fever, cough and dyspnea).
  3. Patients who have mild clinical symptoms that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath (dyspnea).
  4. Screening laboratory values within institutional normal range or judged to be not clinically significant by clinical investigator.
  5. Ability and willingness of subject to give written informed consent.
  6. Negative pregnancy test on the day prior to each vaccination.
  7. Willingness to use adequate contraception by study participants.

Exclusion Criteria:

  1. History of respiratory and cardiovascular diseases, hematologic disease (e.g., cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus, porphyria cutanea tarda).
  2. Autoimmune diseases or clinically serious cardiac, pulmonary, gastrointestinal, hepatic, renal or neurologic disease, which in the opinion of the investigator will compromise ability to participate in the study.
  3. Pregnancy and breast-feeding.
  4. Prior or current systemic cancer chemotherapy.
  5. Investigational agents and immunomodulators (cyclosporine, hematological growth factors, systemic corticosteroids, interleukins or interferons) within 90 days prior to study entry.
  6. Anaphylaxis or allergy to vaccine components.
  7. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
  8. Any other serious diseases other than Covid-19 infection including current or recent (within 5 years) cancers.
  9. Subjects who are immunocompromised or immunosuppressed due to disease or medications.
  10. Women who are lactating.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04428073


Contacts
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Contact: Frank Tung, Ph.D 17702637508 info@genecure.com

Sponsors and Collaborators
GeneCure Biotechnologies
More Information
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Responsible Party: GeneCure Biotechnologies
ClinicalTrials.gov Identifier: NCT04428073    
Other Study ID Numbers: GC004
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The final study results will be published in peer reviewed journals.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GeneCure Biotechnologies:
SARS-CoV-2
COVID-19
therapeutic vaccine