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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05907044
• Other study ID #: YNUVC-2022003
• Status: Completed
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: November 23, 2023

Study information

• Verified date: January 2024
• Source: Affiliated Hospital of Yunnan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: November 23, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• RQ3013
0.15mL/dose containing mRNA 30µg
• RQ3025
0.15mL/dose containing mRNA 30µg
• RQ3027
0.15mL/dose containing mRNA 30µg

Locations

Country	Name	City	State
China	The Affiliated Hospital of Yunnan University	Kunming	Yunnan

Sponsors (3)

Lead Sponsor	Collaborator
Affiliated Hospital of Yunnan University	Kunming Medical University, Yunnan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants with Solicited Local and Systemic Averse Events(AEs)		Up to Day 14( 7 days after vaccination)
Secondary	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
Secondary	Number of Participants with Unsolicited Local and Systemic Averse Events(AEs)		Up to Day 180( 28 days after vaccination)
Secondary	Number of Participants with Serious AEs(SAEs)		Up to Day 180
Secondary	The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-?, IL-4)		Day 7, Day 28, Day 90, Day 180