COVID-19
Conditions
Keywords
mRNA vaccine, SARS-CoV-2
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.
Interventions
BIOLOGICALRQ3013
0.15mL/dose containing mRNA 30μg
BIOLOGICALRQ3025
0.15mL/dose containing mRNA 30μg
BIOLOGICALRQ3027
0.15mL/dose containing mRNA 30μg
Sponsors
Yunnan University
Kunming Medical University
Affiliated Hospital of Yunnan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
China
Outcome results
None listed