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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: RQ3013; Biological: RQ3025; Biological: RQ3027

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650091
      • The Affiliated Hospital of Yunnan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Yunnan University
• Collaborators: Kunming Medical University; Yunnan University

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): June 10, 2023
• Study Completion (Actual): November 23, 2023

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; mRNA vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: YNUVC-2022003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No