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

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID
• Intervention / Treatment: Biological: Covax-19™

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Frank Tung, Ph.D; Phone Number: 17702637508; Email: info@genecure.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GeneCure Biotechnologies

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; therapeutic vaccine
• Other Study ID Numbers: GC004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The final study results will be published in peer reviewed journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No