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

• ClinicalTrials.gov Identifier: NCT04428073
• Recruitment Status: Unknown
• First Posted: June 11, 2020
• Last Update Posted: June 11, 2020
• Sponsor: GeneCure Biotechnologies
• Information provided by (Responsible Party): GeneCure Biotechnologies

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Contacts

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

Sponsors and Collaborators

GeneCure Biotechnologies

More Information

• Responsible Party: GeneCure Biotechnologies
• ClinicalTrials.gov Identifier: NCT04428073
• Other Study ID Numbers: GC004
• First Posted: June 11, 2020
• 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.

• 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