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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Trial of a Therapeutic Vaccine (Covax-19™) in SARS-CoV-2 Infected Patients

Conditions
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COVID

Intervention / Treatment
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* Biological: Covax-19™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documentation of Covid-19 infection based on laboratory evidence of positivity by RT- PCR. Patients who have no clinical symptoms (fever, cough and dyspnea). Patients who have mild clinical symptoms that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath (dyspnea). Screening laboratory values within institutional normal range or judged to be not clinically significant by clinical investigator. Ability and willingness of subject to give written informed consent. Negative pregnancy test on the day prior to each vaccination. Willingness to use adequate contraception by study participants. Exclusion Criteria: History of respiratory and cardiovascular diseases, hematologic disease (e.g., cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus, porphyria cutanea tarda). 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. Pregnancy and breast-feeding. Prior or current systemic cancer chemotherapy. Investigational agents and immunomodulators (cyclosporine, hematological growth factors, systemic corticosteroids, interleukins or interferons) within 90 days prior to study entry. Anaphylaxis or allergy to vaccine components. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. Any other serious diseases other than Covid-19 infection including current or recent (within 5 years) cancers. Subjects who are immunocompromised or immunosuppressed due to disease or medications. Women who are lactating.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose group<br>Subjects will receive 1.0 mL of low dose vaccine at week 0 and 2. | Biological: Covax-19™<br>* Therapeutic vaccine for SARS-CoV-2 infection<br>|
| Experimental: High dose group<br>Subjects will receive 1.0 mL of high dose vaccine at week 0 and 2. | Biological: Covax-19™<br>* Therapeutic vaccine for SARS-CoV-2 infection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response | Magnitude of IFN-γ producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations. | 6 weeks | 
| Virologic response after vaccination | Detection of SARS-CoV-2 by RT-PCR in respiratory tract specimens at week 0, 1, 2, 3, and 4. | 4 weeks | 
| Clinical outcome and progression after vaccinations | Number of participants with moderate, severe or critical Covid-19 at week 6. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic vaccine, SARS-CoV-2, COVID-19