It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
48
Contains 10μg of V-01 and 10μg of V-01-B5
Contains 10μg of V-01-351 and 10μg of V-01-B5
Contains 10μg of V-01
Shaoguan Hospital of Chinese Medicine
Shaoguan, Guangdong, China
Adverse Event (AE)
Observe the AEs occurs at different time point after vaccination
Time frame: 30 minutes after vaccination
AEs
Observe the AEs occurs at different time point after vaccination
Time frame: 0-7 days after vaccination
AEs
Observe the AEs occurs at different time point after vaccination
Time frame: 0-28 days after vaccination
Serious adverse event (SAE) and adverse event of special interest (AESI)
Observe the SAE and AESI after vaccination
Time frame: Within 12 months after vaccination
Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5
Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)
Time frame: 28 days after vaccination
Neutralizing antibody GMT of other SARS-CoV-2 variants
Neutralizing antibody GMT of Delta variant and Omicron variants (BA.2, BA.4, BA.5)
Time frame: Until 12 months after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)
Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT
Time frame: Until 12 months after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)
Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Until 12 months after vaccination
Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level
Anti-SARS-CoV-2 RBD antibody level after vaccination
Time frame: Until 12 months after vaccination