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Study to Assess Safety, Reactogenicity and Immunogenicity of the repRNA(QTP104) Vaccine Against SARS-CoV-2(COVID-19)

Primary Purpose

COVID-19, SARS-CoV-2

Status
Active
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
QTP104 1ug
QTP104 5ug
QTP104 25ug
Sponsored by
Quratis Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring mRNA Vaccine, Replicon mRNA, Self-replicating mRNA

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult male or female aged 19 to 55 years at the screening visit (Visit 1) Subject with a Body Mass Index (BMI) of 18kg/m2 or more and 30kg/m2 or less at the screening visit (Visit 1) Women of childbearing potential who have not undergone sterilization must agree to use an appropriate method of contraception* during this clinical trial period and up to 3 months after the end of administration of the investigational drug and there must be evidence of non-fertility at the screening visit (Visit 1) Men who has not undergone a vasectomy must consent to the use of barrier contraception (i.e., condoms) and if both subejct and partner agree to use an appropriate method of contraception for the duration of the clinical trial and up to 6 months after the end of investigational drug administration Subject who can collect blood and urine during this clinical trial period including the last visit Subject who havs heard the detailed explanation of this clinical trial, have voluntarily decided to participate, and have agreed in writing to abide by the precautions Subject who agrees not to donate blood or transfusion (including whole blood, plasma components, platelet components and platelet plasma components) during the clinical trial period Exclusion Criteria: [Current disease and medical history] Subject who has identified any acute, chronic, or clinically significant disease as a result of a physical or laboratory examination during a screening visit (Visit 1) Subject who has a history of malignant tumors within the past 5 years Subject who has an immune dysfunction, including immunodeficiency disease, or a family history thereof through a medical history and/or physical examination Subject who has positive SARS-CoV-2 IgG Ab results during screening visit (Visit 1) Subject previously diagnosed with COVID-19 Subject with any acute, chronic, or clinically significant disease as a result of physical examination or laboratory examination at the screening visit (Visit 1) Subject with a history of malignancy within 5 years before the first dose of the investigational drug (except for basal cell and squamous cell carcinoma of the skin) Subject with immune dysfunction including immunodeficiency disease through medical history and/or physical examination, or with a family history Subject with a positive result of virus test (hepatitis B test, hepatitis A test, human immunodeficiency virus test, hepatitis C test) at the screening visit (Visit 1) Subject who are significantly abnormal clinically in laboratory tests, electrocardiogram, chest, and X-rays performed at the screening visit (Visit 1) and those who are judged impossible to participate in the clinical trial at the discretion of the investigator Subject with a history of hypersensitivity or severe allergic reaction to vaccine administration [e.g. anaphylaxis, Guillain-Barre syndrome, urticaria*, other clinically significant reactions requiring medical intervention] Urticaria: Those with a history of systemic urticaria within 5 years before administration of investigational drugs Subject with diseases on such systems as hepatobiliary, kidney, nervous system (central or peripheral), respiratory (asthma, pneumonia, etc.), endocrine (uncontrolled diabetes mellitus, hyperlipidemia, etc.), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension) etc.), urinary, psychiatric, musculoskeletal disorders or have a clinically significant history that it is judged to be unable to participate in a clinical trial under the judgment of the investigator Subject with autoimmune diseases including autoimmune hypothyroidism and psoriasis Subject with suspected or history of alcohol or substance abuse 12 months prior to the scheduled screening visit (Visit 1). Alcohol abuse standards are defined as follows: Subject who has had a serious adverse reaction to a drug containing the same component as the investigational drug or has a history of allergy Subject who has had a cough, dyspnea, chills, muscle pain, headache, sore throat, loss of smell or taste and an acute fever in which the body temperature exceeds 37.5°C within 72 hours prior to administration of the clinical trial drug Subject who has been diagnosed with COVID-19 and/or have been confirmed or treated for COVID-19 infection as a result of laboratory tests Subject with a history of previous MERS-CoV or SARS-CoV infection Subject with a history of hereditary or idiopathic angioneurotic edema Subject with a history of organ or bone marrow transplantation [Relating to contraindicated drugs] Subject who has experience in administering an immunosuppressant or immune modifying drug within 6 months prior to administration of an investigational drug Patients with hemophilia who are at risk of serious bleeding when injected intramuscularly or are taking anticoagulants. Subject who has received immunoglobulin or blood-derived products within 3 months prior to administration of the investigational drug or are expected to administer it during the clinical trial period Subject who participated in other clinical trials similar to the investigational drug before the screening visit (Visit 1) Subject with a history of MERS-CoV or SARS-CoV vaccination Subject who haa received or plan to administer the vaccine within 4 weeks before/after administration of this investigational drug Subject with a history of platelet-related disease or hemorrhagic disease, a history of severe bleeding or bruising after intramuscular injection or venipuncture or a person taking anticoagulants If there is a history of dependent administration of psychotropic drugs or narcotic analgesics within 6 months prior to administration of the investigational drug or in case of a mental illness or social condition in which it is difficult to comply with the clinical trial procedure according to the judgment of the investigator

Sites / Locations

  • Severance Hospital
  • Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Injection in the muscle at 0day , 28 day

Injection in the muscle at 0day , 28 day

Injection in the muscle at 0day , 28 day

Outcomes

Primary Outcome Measures

Adverse events(Immediated AEs)
Incidence rate of immediate adverse events (Immediated AEs)
Adverse event(solicited local / systemic AEs)
Incidence rate of expected local and systemic adverse events (solicited local / systemic AEs)
Adverse event(unsolicited AEs)
Incidence rate of unexpected adverse events (unsolicited AEs)
Adverse event(SAEs / serious ADRs)
Incidence rate of serious adverse events and adverse drug reactions (SAEs / serious ADRs)
Adverse event(AESI)
Incidence rate of adverse events of special interest (AESI)

Secondary Outcome Measures

Immunogenicity of QTP104 vaccine as measured by IgG ELISA
Geometric mean titer (GMT) of SARS-CoV-2 Spike (S) protein IgG measured by ELISA at multiple time points after QTP104 administration compared to baseline.
Proportion of subjects for seroconversion of IgG antibodies titer of QTP104
Proportion of subjects with a ≥4-fold increase in IgG antibody titer to SARS-CoV-2 by ELISA at multiple time points after QTP104 administration compared to baseline.
Immunogenicity of QTP104 vaccine as measured by neutralizing antibodies
Geometric mean titer of neutralizing antibody measured by FRNT using Wild-Type Virus at multiple time points after QTP104 administration compared to baseline

Full Information

First Posted
May 1, 2023
Last Updated
May 24, 2023
Sponsor
Quratis Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05876364
Brief Title
Study to Assess Safety, Reactogenicity and Immunogenicity of the repRNA(QTP104) Vaccine Against SARS-CoV-2(COVID-19)
Official Title
A Phase 1, Dose-escalation, Multi-center, Open-label, Study to Evaluate the Safety, Reactogenicity and Immunogenicity of a Preventive SARS-CoV-2 Vaccine (QTP104) in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quratis Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate the safety, reactogenicity, and immunogenicity of the QTP104 vaccine against SARS-CoV-2 infection in healthy adults.
Detailed Description
This study is designed to evaluate the safety, immunogenicity of 3 doses of QTP104. The reason for including 3 doses were to further explore the immunogenicity of these dose levels. This clinical trial is an open label and does not apply to randomized assignment procedures. This study is an open label and does not apply to the maintenance and release procedure of double-blinding. The selection of healthy adults is to confirm the safety of dose-escalation through phase 1 clinical trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
Keywords
mRNA Vaccine, Replicon mRNA, Self-replicating mRNA

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Injection in the muscle at 0day , 28 day
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Injection in the muscle at 0day , 28 day
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Injection in the muscle at 0day , 28 day
Intervention Type
Biological
Intervention Name(s)
QTP104 1ug
Intervention Description
Intramuscular injections of 1 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (QTP104) on days 1 and 28
Intervention Type
Biological
Intervention Name(s)
QTP104 5ug
Intervention Description
Intramuscular injections of 5 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (QTP104) on days 1 and 28
Intervention Type
Biological
Intervention Name(s)
QTP104 25ug
Intervention Description
Intramuscular injections of 25 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (QTP104) on days 1 and 28
Primary Outcome Measure Information:
Title
Adverse events(Immediated AEs)
Description
Incidence rate of immediate adverse events (Immediated AEs)
Time Frame
30 minutes after each administration
Title
Adverse event(solicited local / systemic AEs)
Description
Incidence rate of expected local and systemic adverse events (solicited local / systemic AEs)
Time Frame
7 days after each administration
Title
Adverse event(unsolicited AEs)
Description
Incidence rate of unexpected adverse events (unsolicited AEs)
Time Frame
28 days after each administration
Title
Adverse event(SAEs / serious ADRs)
Description
Incidence rate of serious adverse events and adverse drug reactions (SAEs / serious ADRs)
Time Frame
28 days after each administration
Title
Adverse event(AESI)
Description
Incidence rate of adverse events of special interest (AESI)
Time Frame
394 days from 0 day
Secondary Outcome Measure Information:
Title
Immunogenicity of QTP104 vaccine as measured by IgG ELISA
Description
Geometric mean titer (GMT) of SARS-CoV-2 Spike (S) protein IgG measured by ELISA at multiple time points after QTP104 administration compared to baseline.
Time Frame
Day 0, 29, 57, 180, 394
Title
Proportion of subjects for seroconversion of IgG antibodies titer of QTP104
Description
Proportion of subjects with a ≥4-fold increase in IgG antibody titer to SARS-CoV-2 by ELISA at multiple time points after QTP104 administration compared to baseline.
Time Frame
Day 0, 29, 57, 180, 394
Title
Immunogenicity of QTP104 vaccine as measured by neutralizing antibodies
Description
Geometric mean titer of neutralizing antibody measured by FRNT using Wild-Type Virus at multiple time points after QTP104 administration compared to baseline
Time Frame
Day 0, 29, 57, 180, 394
Other Pre-specified Outcome Measures:
Title
To analyze the ratio of Th1/Th2 by measuring Th1- and Th2-type cytokines through ICS assay
Description
To analyze the ratio of Th1/Th2 by measuring Th1- and Th2-type cytokines through ICS assay at 4weeks after 1st administration of QTP104 and 4weeks, 5months and 12months after 2nd administration of QTP104
Time Frame
Day 0, 29, 57, 180, 394
Title
To analyze the cellular immune responses including number of antigen-specific IFN-γ secreting T cells (IFN-γ ELISPOT Assay)
Description
To analyze the cellular immune responses including number of antigen-specific IFN-γ secreting T cells (IFN-γ ELISPOT Assay) at 4weeks after 1st administration of QTP 104 and 4weeks, 5months and 12months after 2nd administration of QTP104
Time Frame
Day 0, 29, 57, 180, 394

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult male or female aged 19 to 55 years at the screening visit (Visit 1) Subject with a Body Mass Index (BMI) of 18kg/m2 or more and 30kg/m2 or less at the screening visit (Visit 1) Women of childbearing potential who have not undergone sterilization must agree to use an appropriate method of contraception* during this clinical trial period and up to 3 months after the end of administration of the investigational drug and there must be evidence of non-fertility at the screening visit (Visit 1) Men who has not undergone a vasectomy must consent to the use of barrier contraception (i.e., condoms) and if both subejct and partner agree to use an appropriate method of contraception for the duration of the clinical trial and up to 6 months after the end of investigational drug administration Subject who can collect blood and urine during this clinical trial period including the last visit Subject who havs heard the detailed explanation of this clinical trial, have voluntarily decided to participate, and have agreed in writing to abide by the precautions Subject who agrees not to donate blood or transfusion (including whole blood, plasma components, platelet components and platelet plasma components) during the clinical trial period Exclusion Criteria: [Current disease and medical history] Subject who has identified any acute, chronic, or clinically significant disease as a result of a physical or laboratory examination during a screening visit (Visit 1) Subject who has a history of malignant tumors within the past 5 years Subject who has an immune dysfunction, including immunodeficiency disease, or a family history thereof through a medical history and/or physical examination Subject who has positive SARS-CoV-2 IgG Ab results during screening visit (Visit 1) Subject previously diagnosed with COVID-19 Subject with any acute, chronic, or clinically significant disease as a result of physical examination or laboratory examination at the screening visit (Visit 1) Subject with a history of malignancy within 5 years before the first dose of the investigational drug (except for basal cell and squamous cell carcinoma of the skin) Subject with immune dysfunction including immunodeficiency disease through medical history and/or physical examination, or with a family history Subject with a positive result of virus test (hepatitis B test, hepatitis A test, human immunodeficiency virus test, hepatitis C test) at the screening visit (Visit 1) Subject who are significantly abnormal clinically in laboratory tests, electrocardiogram, chest, and X-rays performed at the screening visit (Visit 1) and those who are judged impossible to participate in the clinical trial at the discretion of the investigator Subject with a history of hypersensitivity or severe allergic reaction to vaccine administration [e.g. anaphylaxis, Guillain-Barre syndrome, urticaria*, other clinically significant reactions requiring medical intervention] Urticaria: Those with a history of systemic urticaria within 5 years before administration of investigational drugs Subject with diseases on such systems as hepatobiliary, kidney, nervous system (central or peripheral), respiratory (asthma, pneumonia, etc.), endocrine (uncontrolled diabetes mellitus, hyperlipidemia, etc.), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension) etc.), urinary, psychiatric, musculoskeletal disorders or have a clinically significant history that it is judged to be unable to participate in a clinical trial under the judgment of the investigator Subject with autoimmune diseases including autoimmune hypothyroidism and psoriasis Subject with suspected or history of alcohol or substance abuse 12 months prior to the scheduled screening visit (Visit 1). Alcohol abuse standards are defined as follows: Subject who has had a serious adverse reaction to a drug containing the same component as the investigational drug or has a history of allergy Subject who has had a cough, dyspnea, chills, muscle pain, headache, sore throat, loss of smell or taste and an acute fever in which the body temperature exceeds 37.5°C within 72 hours prior to administration of the clinical trial drug Subject who has been diagnosed with COVID-19 and/or have been confirmed or treated for COVID-19 infection as a result of laboratory tests Subject with a history of previous MERS-CoV or SARS-CoV infection Subject with a history of hereditary or idiopathic angioneurotic edema Subject with a history of organ or bone marrow transplantation [Relating to contraindicated drugs] Subject who has experience in administering an immunosuppressant or immune modifying drug within 6 months prior to administration of an investigational drug Patients with hemophilia who are at risk of serious bleeding when injected intramuscularly or are taking anticoagulants. Subject who has received immunoglobulin or blood-derived products within 3 months prior to administration of the investigational drug or are expected to administer it during the clinical trial period Subject who participated in other clinical trials similar to the investigational drug before the screening visit (Visit 1) Subject with a history of MERS-CoV or SARS-CoV vaccination Subject who haa received or plan to administer the vaccine within 4 weeks before/after administration of this investigational drug Subject with a history of platelet-related disease or hemorrhagic disease, a history of severe bleeding or bruising after intramuscular injection or venipuncture or a person taking anticoagulants If there is a history of dependent administration of psychotropic drugs or narcotic analgesics within 6 months prior to administration of the investigational drug or in case of a mental illness or social condition in which it is difficult to comply with the clinical trial procedure according to the judgment of the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Hwa Choi
Organizational Affiliation
Quratis Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joon-Sup Yeom, MD/PhD
Organizational Affiliation
Infectious Disease, Severance Hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young Goo Song, MD/PhD
Organizational Affiliation
Infectious Diseases, Gangnam Severance Hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://www.mfds.go.kr
Description
korea

Learn more about this trial

Study to Assess Safety, Reactogenicity and Immunogenicity of the repRNA(QTP104) Vaccine Against SARS-CoV-2(COVID-19)

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