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

NCT05876364 | Unknown Phase 1 FDA Drug

• 1 other identifier: CT-QTP104-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to evaluate the safety, reactogenicity, and immunogenicity of the QTP104 vaccine against SARS-CoV-2 infection in healthy adults.

Conditions

COVID-19; SARS-CoV-2

Keywords

mRNA Vaccine; Replicon mRNA; Self-replicating mRNA

Outcome Measures

Primary Outcomes (5)

• Adverse events(Immediated AEs)

  Incidence rate of immediate adverse events (Immediated AEs)

  30 minutes after each administration

• Adverse event(solicited local / systemic AEs)

  Incidence rate of expected local and systemic adverse events (solicited local / systemic AEs)

  7 days after each administration

• Adverse event(unsolicited AEs)

  Incidence rate of unexpected adverse events (unsolicited AEs)

  28 days after each administration

• Adverse event(SAEs / serious ADRs)

  Incidence rate of serious adverse events and adverse drug reactions (SAEs / serious ADRs)

  28 days after each administration

• Adverse event(AESI)

  Incidence rate of adverse events of special interest (AESI)

  394 days from 0 day

Secondary Outcomes (3)

• Immunogenicity of QTP104 vaccine as measured by IgG ELISA

  Day 0, 29, 57, 180, 394

• Proportion of subjects for seroconversion of IgG antibodies titer of QTP104

  Day 0, 29, 57, 180, 394

• Immunogenicity of QTP104 vaccine as measured by neutralizing antibodies

  Day 0, 29, 57, 180, 394

Other Outcomes (2)

• To analyze the ratio of Th1/Th2 by measuring Th1- and Th2-type cytokines through ICS assay

  Day 0, 29, 57, 180, 394

• To analyze the cellular immune responses including number of antigen-specific IFN-γ secreting T cells (IFN-γ ELISPOT Assay)

  Day 0, 29, 57, 180, 394

Study Arms (3)

Cohort 1

EXPERIMENTAL

Injection in the muscle at 0day , 28 day

Biological: QTP104 1ug

Cohort 2

EXPERIMENTAL

Injection in the muscle at 0day , 28 day

Biological: QTP104 5ug

Cohort 3

EXPERIMENTAL

Injection in the muscle at 0day , 28 day

Biological: QTP104 25ug

Interventions

QTP104 1ug BIOLOGICAL

Intramuscular injections of 1 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (QTP104) on days 1 and 28

Cohort 1

QTP104 5ug BIOLOGICAL

Intramuscular injections of 5 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (QTP104) on days 1 and 28

Cohort 2

QTP104 25ug BIOLOGICAL

Intramuscular injections of 25 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (QTP104) on days 1 and 28

Cohort 3

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \[Current disease and medical history\]
• 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

Sponsors & Collaborators

• Quratis Inc.: lead

Study Sites (2)

Severance Hospital

Seoul, 03722, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Related Links

• korea

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Yu Hwa Choi

  Quratis Inc.

  STUDY DIRECTOR

• Joon-Sup Yeom, MD/PhD

  Infectious Disease, Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

• Young Goo Song, MD/PhD

  Infectious Diseases, Gangnam Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 25, 2023
• Study Start: November 19, 2021
• Primary Completion: June 13, 2022
• Study Completion: August 30, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

KR (2)