Clinical trial NCT04428073: Therapeutic Vaccine Trial of COVID-19 for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Official title: A Phase I Trial of a Therapeutic Vaccine (Covax-19™) in SARS-CoV-2 Infected Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID
Keywords: SARS-CoV-2
COVID-19
therapeutic vaccine
Lead sponsor: GeneCure Biotechnologies
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 26 weeks
Secondary outcomes:
measure: To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response
timeFrame: 6 weeks
measure: Virologic response after vaccination
timeFrame: 4 weeks
measure: Clinical outcome and progression after vaccinations
timeFrame: 6 weeks
Other outcomes:
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Study officials:
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