A Clinical Study to Evaluate the Safety and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines
This is a single arm, open-label clinical study. 34 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines will be enrolled in this study to evaluate the safety and immunogenicity of V-01. The participants will be collected blood before immunization, on day 7, day 14, day 28, day 90 and 6 month to evaluate humoral immunity. All adverse events (AEs) within 30 minutes and 0-7 days after booster immunization, and unsolicited AEs from 8 to 28 days after booster immunization, as well as SAEs and AESIs from the first vaccination to 12 months after booster immunization will be collected from all participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
34
The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.
The Fifth Peoples' Hospital of Zhuhai
Zhuhai, Guangdong, China
Incidence of adverse events (AEs)
The incidence of adverse events (AEs) occured within 30 minutes, 0-7 days, 0-30 days after booster immunization, as well as SAEs and AESIs from the first vaccination to 12 months after booster immunization.
Time frame: Within 12 months after booster immunization.
Geometric Mean Titer (GMT)
GMT of SARS-CoV-2 neutralizing antibody on 14 days and 28 days after booster immunization
Time frame: 28 days after booster immunization
Geometric Mean Increase (GMI)
GMI of SARS-CoV-2 neutralizing antibody on 14 days and 28 days after booster immunization
Time frame: 28 days after booster immunization
Seroconvension rate
Seroconvension rate of SARS-CoV-2 neutralizing antibody on 14 days and 28 days after booster immunization
Time frame: 28 days after booster immunization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.