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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: RQ3013
* Biological: RQ3025
* Biological: RQ3027


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RQ3013<br>C-3013B-202211005, Alpha/Beta, mRNA 30μg dose | Biological: RQ3013<br>* 0.15mL/dose containing mRNA 30μg<br>|
| Experimental: RQ3025<br>INDA-3025TB-20221002, Alpha/Beta + Omicron BA.2/4/5, mRNA 30μg dose | Biological: RQ3025<br>* 0.15mL/dose containing mRNA 30μg<br>|
| Experimental: RQ3027<br>IND-3027TB-202304001, Alpha/Beta + Omicron XBB.1.5, mRNA 30μg dose | Biological: RQ3027<br>* 0.15mL/dose containing mRNA 30μg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5 |  | Day 14 | 
| Number of Participants with Solicited Local and Systemic Averse Events(AEs) |  | Up to Day 14( 7 days after vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5 |  | Day 0, Day 7, Day 28, Day 90, Day 180 | 
| Number of Participants with Unsolicited Local and Systemic Averse Events(AEs) |  | Up to Day 180( 28 days after vaccination) | 
| Number of Participants with Serious AEs(SAEs) |  | Up to Day 180 | 
| The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-γ, IL-4) |  | Day 7, Day 28, Day 90, Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mRNA vaccine, SARS-CoV-2