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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04428073
• Other study ID #: GC004
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 2020
• Est. completion date: December 2021

Study information

• Verified date: June 2020
• Source: GeneCure Biotechnologies
• Contact: Frank Tung, Ph.D
• Phone: 17702637508
• Email: info[@]genecure.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID

Intervention

Biological:
• Covax-19™
Therapeutic vaccine for SARS-CoV-2 infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GeneCure Biotechnologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response	Magnitude of IFN-? producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations.	6 weeks
Secondary	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
Secondary	Clinical outcome and progression after vaccinations	Number of participants with moderate, severe or critical Covid-19 at week 6.	6 weeks