COVID-19
Conditions
Brief summary
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.
Interventions
BIOLOGICALthe recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine
one booster dose intramuscularly in the deltoid muscle of the upper arm.
Sponsors
Binhui Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Eligible participants were those who completed the two-dose primary series of ICV for 6-15 months * Voluntarily consented to participate in this trial * Agreed to take effective contraceptive measures (women of childbearing potential) from signing the informed consent form to 12 months after booster vaccination.
Exclusion criteria
* History of allergy to any vaccine or its excipients; * Presence of severe, uncontrollable or hospitalized diseases; * History of major surgery within 3 months prior to enrollment; * History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or COVID-19; * Congenital or acquired immunodeficiency or autoimmune disease; * Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrollment; * Receipt of any COVID-19 prophylactic medication other than primary series of ICV; * Long-term receipt (\>14 consecutive days) of glucocorticoids or other immunosuppressive agents within the past 6 months; * Receipt of biological agents, immunopotentiators or immunosuppressants within the past 6 months; * Receipt of blood or blood-related products within 3 months prior to vaccination; * Administration of antipyretics, painkillers or antiallergics within 24 hours prior to vaccination; * Participating or planning to participate in other clinical trials during the study period; * Pregnant or lactating females, women of childbearing age of pregnancy test positive; * Presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | within 30 minutes after booster immunization | All adverse events within 30 minutes of booster immunization |
| humoral immunogenicity | On Day 14 and Day 28 after booster immunization | The Geometric Mean Titer (GMT) of neutralizing antibody against Delta, Omicron BA.2.2 and Omicron BA.5.2 after the booster immunization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| humoral immunogenicity | On 3rd month, 6th month after booster immunization | The Geometric Mean Titer (GMT) of neutralizing antibody against Delta, Omicron BA.2.2 and Omicron BA.5.2 after the 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. | 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| exploratory endpoints | on 0, 14 days, 3 months, 6 months after booster immunization | Proportion of CD4+ cell subsets |
Countries
China
Outcome results
None listed