Increased immune escape of emerging SARS-CoV-2 variants and waning neutralizing antibody levels over time indicate the importance of COVID-19 vaccine booster dose. Preclinical findings have shown that the recombinant SARS-CoV-2 S-Trimer vaccine exhibited favorable safety and immunogenicity. Herein, we conducted a randomized, open-label, positive control trial to assess the safety and immunogenicity of the booster shot in healthy subjects aged 18-59 years who have completed two-dose primary series of inactivated vaccine for 6-15 months. A total of 63 eligible participants were enrolled to receive the recombinant SARS-CoV-2 S-Trimer vaccine or inactivated vaccine, and only one participant in 30 μg recombinant SARS-CoV-2 S-Trimer vaccine cohort withdrew owing to personal work reasons on September 26, 2022. Subjects in each dose group (5 μg, 10 μg, 30 μg recombinant SARS-CoV-2 S-Trimer vaccine) was randomly assigned to receive the experimental vaccine or inactivated vaccine in a 2:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
one booster dose intramuscularly in the deltoid muscle of the upper arm.
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
Incidence of Treatment-Emergent Adverse Events
All adverse events within 30 minutes of booster immunization
Time frame: within 30 minutes after booster immunization
Incidence of Treatment-Emergent Adverse Events
Solicited local/systemic AEs within 7 days of booster immunization
Time frame: within 7 days of booster immunization
Incidence of Treatment-Emergent Adverse Events
Unsolicited local/systemic AEs within 28 days of booster immunization
Time frame: within 28 days of booster immunization
humoral immunogenicity
The Geometric Mean Titer (GMT) of neutralizing antibody against Delta, Omicron BA.2.2 and Omicron BA.5.2 after the booster immunization
Time frame: On Day 14 and Day 28 after booster immunization
humoral immunogenicity
The Geometric Mean Fold Rises (GMFR) of neutralizing antibody against Delta, Omicron BA.2.2 and Omicron BA.5.2 after the booster immunization
Time frame: On Day 14 and Day 28 after booster immunization
humoral immunogenicity
The seroconversion rate of neutralizing antibody against Delta, Omicron BA.2.2 and Omicron BA.5.2 after the booster immunization
Time frame: On Day 14 and Day 28 after booster immunization
humoral immunogenicity
The Geometric Mean Titer (GMT) of neutralizing antibody against Delta, Omicron BA.2.2 and Omicron BA.5.2 after the booster immunization
Time frame: On 3rd month, 6th month after booster immunization
humoral immunogenicity
The Geometric Mean Fold Rises (GMFR) of neutralizing antibody against Delta, Omicron BA.2.2 and Omicron BA.5.2 after the booster immunization
Time frame: On 3rd month, 6th month after booster immunization
The safety outcomes were the counts and percentages of AEs, including SAEs and AESIs within 12 months, changes in laboratory safety parameters on the 3rd day following booster vaccination in comparison to baseline.
The safety outcomes were the counts and percentages of AEs, including severe adverse events (SAEs) and adverse of special interest (AESIs) within 12 months, changes in laboratory safety parameters on the 3rd day following booster vaccination in comparison to baseline.
Time frame: 12 months
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