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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RQ3013
RQ3025
RQ3027
Sponsored by
Affiliated Hospital of Yunnan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring mRNA vaccine, SARS-CoV-2

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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: 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

Sites / Locations

  • The Affiliated Hospital of Yunnan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

RQ3013

RQ3025

RQ3027

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
Number of Participants with Solicited Local and Systemic Averse Events(AEs)

Secondary Outcome Measures

Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
Number of Participants with Unsolicited Local and Systemic Averse Events(AEs)
Number of Participants with Serious AEs(SAEs)
The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-γ, IL-4)

Full Information

First Posted
June 8, 2023
Last Updated
June 22, 2023
Sponsor
Affiliated Hospital of Yunnan University
Collaborators
Yunnan University, Kunming Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05907044
Brief Title
A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults
Official Title
An Interventional, Randomized, Parallel Controlled, Investigator Initiated Study to Investigate the Safety, Immunogenicity of Bivalent RQ3027 and RQ3025 mRNA Vaccine as a Booster Dose in 3 Doses COVID-19 Vaccine-Experienced Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
June 10, 2023 (Actual)
Study Completion Date
November 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Yunnan University
Collaborators
Yunnan University, Kunming Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
mRNA vaccine, SARS-CoV-2

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RQ3013
Arm Type
Active Comparator
Arm Description
C-3013B-202211005, Alpha/Beta, mRNA 30μg dose
Arm Title
RQ3025
Arm Type
Experimental
Arm Description
INDA-3025TB-20221002, Alpha/Beta + Omicron BA.2/4/5, mRNA 30μg dose
Arm Title
RQ3027
Arm Type
Experimental
Arm Description
IND-3027TB-202304001, Alpha/Beta + Omicron XBB.1.5, mRNA 30μg dose
Intervention Type
Biological
Intervention Name(s)
RQ3013
Intervention Description
0.15mL/dose containing mRNA 30μg
Intervention Type
Biological
Intervention Name(s)
RQ3025
Intervention Description
0.15mL/dose containing mRNA 30μg
Intervention Type
Biological
Intervention Name(s)
RQ3027
Intervention Description
0.15mL/dose containing mRNA 30μg
Primary Outcome Measure Information:
Title
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
Title
Number of Participants with Solicited Local and Systemic Averse Events(AEs)
Time Frame
Up to Day 14( 7 days after vaccination)
Secondary Outcome Measure Information:
Title
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
Title
Number of Participants with Unsolicited Local and Systemic Averse Events(AEs)
Time Frame
Up to Day 180( 28 days after vaccination)
Title
Number of Participants with Serious AEs(SAEs)
Time Frame
Up to Day 180
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Facility Information:
Facility Name
The Affiliated Hospital of Yunnan University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuanjing YU
Phone
0871-65032538
Email
xuanjingyu@genvoo.com.cn

12. IPD Sharing Statement

Learn more about this trial

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

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