Clinical trial NCT05907044: 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
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: mRNA vaccine
SARS-CoV-2
Lead sponsor: Affiliated Hospital of Yunnan University
Sponsor class: OTHER
Collaborators: name: Yunnan University
name: Kunming Medical University
First posted: 2023-06-18
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
timeFrame: Day 14
measure: Number of Participants with Solicited Local and Systemic Averse Events(AEs)
timeFrame: Up to Day 14( 7 days after vaccination)
Secondary outcomes:
measure: Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
timeFrame: Day 0, Day 7, Day 28, Day 90, Day 180
measure: Number of Participants with Unsolicited Local and Systemic Averse Events(AEs)
timeFrame: Up to Day 180( 28 days after vaccination)
measure: Number of Participants with Serious AEs(SAEs)
timeFrame: Up to Day 180
measure: The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-γ, IL-4)
timeFrame: Day 7, Day 28, Day 90, Day 180
Other outcomes:
Locations:
city: Kunming
country: China
facility: The Affiliated Hospital of Yunnan University
state: Yunnan
Study officials:
References: