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

NCT04428073 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: GC004
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Keywords

SARS-CoV-2; COVID-19; therapeutic vaccine

Outcome Measures

Primary Outcomes (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.

  Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations.

  26 weeks

Secondary Outcomes (3)

• To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response

  6 weeks

• Virologic response after vaccination

  4 weeks

• Clinical outcome and progression after vaccinations

  6 weeks

Study Arms (2)

Low dose group

EXPERIMENTAL

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

Biological: Covax-19™

High dose group

EXPERIMENTAL

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

Biological: Covax-19™

Interventions

Covax-19™ BIOLOGICAL

Therapeutic vaccine for SARS-CoV-2 infection

High dose group; Low dose group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Documentation of Covid-19 infection based on laboratory evidence of positivity by RT- PCR.
• Patients who have no clinical symptoms (fever, cough and dyspnea).
• Patients who have mild clinical symptoms that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath (dyspnea).
• Screening laboratory values within institutional normal range or judged to be not clinically significant by clinical investigator.
• Ability and willingness of subject to give written informed consent.
• Negative pregnancy test on the day prior to each vaccination.
• Willingness to use adequate contraception by study participants.

You may not qualify if:

• History of respiratory and cardiovascular diseases, hematologic disease (e.g., cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus, porphyria cutanea tarda).
• 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.
• Pregnancy and breast-feeding.
• Prior or current systemic cancer chemotherapy.
• Investigational agents and immunomodulators (cyclosporine, hematological growth factors, systemic corticosteroids, interleukins or interferons) within 90 days prior to study entry.
• Anaphylaxis or allergy to vaccine components.
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
• Any other serious diseases other than Covid-19 infection including current or recent (within 5 years) cancers.
• Subjects who are immunocompromised or immunosuppressed due to disease or medications.
• Women who are lactating.

Sponsors & Collaborators

• GeneCure Biotechnologies: lead

MeSH Terms

Conditions

COVID-19

Interventions

SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Frank Tung, Ph.D

CONTACT

17702637508; info@genecure.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share