This study is a continuation study of the original V-01-I phase trial, using a single-center, single-arm, open design to evaluate the immunogenicity and safety of the third dose booster immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in healthy participants immunized with two doses schedule of V-01. The primary objective is to evaluate the Immunogenicity of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01. The secondary objective is to evaluate the safety of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.
The plan is to booster immunize the participants previously in 10μg test group in V-01 clinical trial phase I, 48 participants are planned to be enrolled. The actual case number will be calculated by the participants who signed the ICF and got actual inoculation with the third dose. Vaccination and follow-up: Three to six months after the two doses of V-01 (10 μg) were vaccinated, the participants received a booster dose of investigational vaccine (V-01, 10 μg) at the deltoid muscle of the upper arm. Perform safety and immunogenicity related inspections in accordance with the schedule in the plan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
43
The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.
Guangdong Provincial Center for Disease Control and Prevention
Guangzhou, Guangdong, China
Immunogenicity Endpoints
1. The seroconvension, GMT, and GMI of SARS-CoV-2 neutralizing antibodies (live virus, pseudovirus neutralizing test method) 2. The seroconvension, GMT, and GMI of SARS-CoV-2 RBD antibodies (Enzyme-linked Immuno Sorbent Assay,ELISA)
Time frame: 14 days after booster immunization
Safety Endpoints
1. The occurrence of AEs at each time point (at least 30 minutes, 0-7 days, and within 30 days after booster vaccination); 2. The incidence of serious adverse events (SAE) (within 6 months after booster vaccination).
Time frame: Day 0-7 after booster immunization, 6 months after booster immunization
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