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

Affiliated Hospital of Yunnan University

Status: Completed

Conditions: COVID-19

Treatments: Biological: RQ3013; Biological: RQ3025; Biological: RQ3027

Study type: Interventional

Funder types: Other

Identifiers

NCT05907044

YNUVC-2022003

Details and patient eligibility

About

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.

Enrollment: 376 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

376 participants in 3 patient groups

RQ3013

Active Comparator group

Description:

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

Treatment:

Biological: RQ3013

RQ3025

Experimental group

Description:

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

Treatment:

Biological: RQ3025

RQ3027

Experimental group

Description:

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

Treatment:

Biological: RQ3027