It is a single center, randomized, open-labeled, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine V-01D-351 as a booster.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
Shaoguan Hospital of Chinese Medicine
Shaoguan, Guangdong, China
Neutralizing antibody 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: 7 days, 14 days, 28 days, 3 months, 6 months and 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: 7 days, 14 days, 28 days, 3 months, 6 months and 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
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Total IgG antibody level
Total IgG antibody level of SARS-CoV-2
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Spike protein antibody level
Antibody level of anti-SARS-CoV-2 spike protein
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
RBD antibody level
Anti-SARS-CoV-2 RBD antibody level
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
Specific cytokine secretion levels
Specific cytokine secretion levels such as IFN-γ
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
AEs
Observe the AEs occurs at different time point after vaccination
Time frame: 30 minutes, 0-7 days, 0-28 days after vaccination
SAE and AESI
Observe the SAE and AESI after vaccination
Time frame: Within 12 months after vaccination