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

NCT05876364 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-05-25

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

QTP104 1ug

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

BIOLOGICAL

QTP104 5ug

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

BIOLOGICAL

QTP104 25ug

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

Sponsors & Collaborators

  • Quratis Inc.

    lead INDUSTRY

Principal Investigators

  • Yu Hwa Choi · Quratis Inc.

  • Joon-Sup Yeom, MD/PhD · Infectious Disease, Severance Hospital, Yonsei University College of Medicine

  • Young Goo Song, MD/PhD · Infectious Diseases, Gangnam Severance Hospital, Yonsei University College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-19
Primary Completion
2022-06-13
Completion
2023-08-30
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05876364 on ClinicalTrials.gov