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Clinical Trials/NCT04428073
NCT04428073UnknownPhase 1

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

GeneCure Biotechnologies0 sites32 target enrollmentStarted: July 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Enrollment
32
Primary Endpoint
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.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

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 Outcomes

  • Virologic response after vaccination(4 weeks)
  • To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response(6 weeks)
  • Clinical outcome and progression after vaccinations(6 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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