A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults
NCT ID: NCT05907044
Last Updated: 2024-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
376 participants
INTERVENTIONAL
2023-05-08
2023-11-23
Brief Summary
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* The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA vaccine RQ3013 against the current SARS-CoV-2 circulating variant.
* The safety profile of RQ3027 and RQ3025 given as a second booster dose to COVID-19 vaccine-experienced participants 18 through 55 years of age.
* Explore the protective efficacy by documenting confirmed COVID-19 cases after vaccination.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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RQ3013
C-3013B-202211005, Alpha/Beta, mRNA 30μg dose
RQ3013
0.15mL/dose containing mRNA 30μg
RQ3025
INDA-3025TB-20221002, Alpha/Beta + Omicron BA.2/4/5, mRNA 30μg dose
RQ3025
0.15mL/dose containing mRNA 30μg
RQ3027
IND-3027TB-202304001, Alpha/Beta + Omicron XBB.1.5, mRNA 30μg dose
RQ3027
0.15mL/dose containing mRNA 30μg
Interventions
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RQ3013
0.15mL/dose containing mRNA 30μg
RQ3025
0.15mL/dose containing mRNA 30μg
RQ3027
0.15mL/dose containing mRNA 30μg
Eligibility Criteria
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Inclusion Criteria
* Participants 18 through 55 years of ages.
* Participants who have received at least 3 doses COVID-19 vaccine.
* Participants with the last prior dose being 90 or more days before Visit 1(Day 0) or recovered from COVID-19 at least 28 days.
* Participants able to comply with all scheduled visits, laboratory tests and investigator's instruction.
Exclusion Criteria
* Enrolling in or planning to participate other interventional clinical study.
* Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
* History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
* Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
* Continued using anticoagulants such as coumarin and related anticoagulants (i.e., warfarin) or oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran, and edoxaban).
* Having coronary heart disease, hypertension, diabetes, chronic respiratory diseases, tumors and poorly controlled.
* Immunocompromised or having immunosuppressive therapy.
* Suspected or confirmed alcohol/drug dependence.
* Investigator decide unsuitable factors for participating in clinical trials in the investigator's judgment
18 Years
55 Years
ALL
Yes
Sponsors
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Yunnan University
UNKNOWN
Kunming Medical University
OTHER
Affiliated Hospital of Yunnan University
OTHER
Responsible Party
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Jia Wei
Professor
Locations
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The Affiliated Hospital of Yunnan University
Kunming, Yunnan, China
Countries
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Other Identifiers
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YNUVC-2022003
Identifier Type: -
Identifier Source: org_study_id
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