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CompletedNCT05907044Updated Jan 24, 2024

A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults

An interventional study of RQ3013 and RQ3025 in COVID-19, sponsored by Affiliated Hospital of Yunnan University. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-24.

Sponsored by Affiliated Hospital of Yunnan University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
376
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are:

  • 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.
02

Conditions studied

  • COVID-19

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Keywords

  • mRNA vaccine
  • SARS-CoV-2
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 376 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Affiliated Hospital of Yunnan University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
  • 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

Exclusion Criteria:

  • Women who are pregnant or breastfeeding.
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
376 participants (actual)

Study arms

  • Active comparator
    RQ3013

    C-3013B-202211005, Alpha/Beta, mRNA 30μg dose

    Biological: RQ3013

  • Experimental
    RQ3025

    INDA-3025TB-20221002, Alpha/Beta + Omicron BA.2/4/5, mRNA 30μg dose

    Biological: RQ3025

  • Experimental
    RQ3027

    IND-3027TB-202304001, Alpha/Beta + Omicron XBB.1.5, mRNA 30μg dose

    Biological: RQ3027

Interventions

  • BiologicalRQ3013

    0.15mL/dose containing mRNA 30μg

  • BiologicalRQ3025

    0.15mL/dose containing mRNA 30μg

  • BiologicalRQ3027

    0.15mL/dose containing mRNA 30μg

06

What researchers measure

Primary outcomes

  1. Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5

    Time frame: Day 14

  2. Number of Participants with Solicited Local and Systemic Averse Events(AEs)

    Time frame: Up to Day 14( 7 days after vaccination)

Secondary outcomes

  1. Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5

    Time frame: Day 0, Day 7, Day 28, Day 90, Day 180

  2. Number of Participants with Unsolicited Local and Systemic Averse Events(AEs)

    Time frame: Up to Day 180( 28 days after vaccination)

  3. Number of Participants with Serious AEs(SAEs)

    Time frame: Up to Day 180

  4. The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-γ, IL-4)

    Time frame: Day 7, Day 28, Day 90, Day 180

07

Study locations

1 site
  • The Affiliated Hospital of Yunnan University
    Kunming, Yunnan 650091, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05907044
Lead sponsor
Affiliated Hospital of Yunnan University
Collaborators
Yunnan University, Kunming Medical University
Responsible party
Jia Wei (Professor, Affiliated Hospital of Yunnan University) — Principal investigator
First posted
Jun 18, 2023
Start date
May 8, 2023
Primary completion
Jun 10, 2023
Completion
Nov 23, 2023
Last update
Jan 24, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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