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

NCT ID: NCT04428073

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2021-12-31

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.

Conditions

COVID

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose group

Subjects will receive 1.0 mL of low dose vaccine at week 0 and 2.

Group Type: EXPERIMENTAL

Covax-19™

Intervention Type: BIOLOGICAL

Therapeutic vaccine for SARS-CoV-2 infection

High dose group

Subjects will receive 1.0 mL of high dose vaccine at week 0 and 2.

Group Type: EXPERIMENTAL

Covax-19™

Intervention Type: BIOLOGICAL

Therapeutic vaccine for SARS-CoV-2 infection

Interventions

Covax-19™

Therapeutic vaccine for SARS-CoV-2 infection

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GeneCure Biotechnologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Frank Tung, Ph.D

Role: CONTACT

info@genecure.com

17702637508

Other Identifiers

GC004

Identifier Type: -

Identifier Source: org_study_id