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COVID-19Phase 1NCT05876364

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

A Phase 1 study testing QTP104 1ug, QTP104 5ug and QTP104 25ug in people with COVID-19 and SARS-CoV-2, run by Quratis Inc. at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS-CoV-2
What is being tested?
QTP104 1ug, QTP104 5ug and QTP104 25ug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesSouth Korea
Study dates
19 Nov 2021to 30 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • [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
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  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Severance Hospital

    Seoul, 03722

  • Gangnam Severance Hospital

    Seoul, 06273

Other trials in South Korea

About this study

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

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

Read the 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.

Conditions
COVID-19, SARS-CoV-2
Being tested
QTP104 1ug, QTP104 5ug, QTP104 25ug
Keywords
mRNA Vaccine, Replicon mRNA, Self-replicating mRNA
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QTP104 1ugBiological

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

  • QTP104 5ugBiological

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

  • QTP104 25ugBiological

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

Study groups in NCT05876364
Study groupRoleWhat they receive
Cohort 1ExperimentalInjection in the muscle at 0day , 28 day
Receives: Biological: QTP104 1ug
Cohort 2ExperimentalInjection in the muscle at 0day , 28 day
Receives: Biological: QTP104 5ug
Cohort 3ExperimentalInjection in the muscle at 0day , 28 day
Receives: Biological: QTP104 25ug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events(Immediated AEs)

    Incidence rate of immediate adverse events (Immediated AEs)

    Measured: 30 minutes after each administration

  2. Adverse event(solicited local / systemic AEs)

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

    Measured: 7 days after each administration

  3. Adverse event(unsolicited AEs)

    Incidence rate of unexpected adverse events (unsolicited AEs)

    Measured: 28 days after each administration

  4. Adverse event(SAEs / serious ADRs)

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

    Measured: 28 days after each administration

  5. Adverse event(AESI)

    Incidence rate of adverse events of special interest (AESI)

    Measured: 394 days from 0 day

Secondary outcomes (3)

  1. 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.

    Measured: Day 0, 29, 57, 180, 394

  2. 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.

    Measured: Day 0, 29, 57, 180, 394

  3. 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

    Measured: Day 0, 29, 57, 180, 394

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study start19 Nov 2021
  3. Primary completion13 Jun 2022
  4. Study completion30 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05876364
Sponsor's protocol ID
CT-QTP104-002
Status last verified
May 2023
First submitted
1 May 2023
Last updated
25 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing QTP104 1ug, QTP104 5ug and QTP104 25ug in people with COVID-19 and SARS-CoV-2, run by Quratis Inc. at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events(Immediated AEs) (time frame: 30 minutes after each administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05876364.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.

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