Clinical Trial of Safety and Immunogenicity of Recombinant SARS-CoV-2 S-Trimer Vaccine (CHO Cells) as Booster Vaccination in Populations Aged 18 to 59 Years

NCT05716347 | Terminated Early Phase 1

• 1 other identifier: BS033VX-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events

  All adverse events within 30 minutes of booster immunization

  within 30 minutes after booster immunization

• Incidence of Treatment-Emergent Adverse Events

  Solicited local/systemic AEs within 7 days of booster immunization

  within 7 days of booster immunization

• Incidence of Treatment-Emergent Adverse Events

  Unsolicited local/systemic AEs within 28 days of booster immunization

  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

  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

  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

  On Day 14 and Day 28 after booster immunization

Secondary Outcomes (3)

• humoral immunogenicity

  On 3rd month, 6th month after booster immunization

• humoral immunogenicity

  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.

  12 months

Other Outcomes (3)

• exploratory endpoints

  on 0, 14 days, 3 months, 6 months after booster immunization

• exploratory endpoints

  on 0, 14 days, 3 months, 6 months after booster immunization

• exploratory endpoints

  on 0, 14 days, 3 months, 6 months after booster immunization

Study Arms (4)

the 5 μg recombinant SARS-CoV-2 S-Trimer vaccine booster group

EXPERIMENTAL

Biological: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine

the 10 μg recombinant SARS-CoV-2 S-Trimer vaccine booster group

EXPERIMENTAL

Biological: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine

the 30 μg recombinant SARS-CoV-2 S-Trimer vaccine booster group

EXPERIMENTAL

Biological: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine

ICV booster group

ACTIVE COMPARATOR

Biological: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine

Interventions

the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine BIOLOGICAL

one booster dose intramuscularly in the deltoid muscle of the upper arm.

ICV booster group; the 10 μg recombinant SARS-CoV-2 S-Trimer vaccine booster group; the 30 μg recombinant SARS-CoV-2 S-Trimer vaccine booster group; the 5 μg recombinant SARS-CoV-2 S-Trimer vaccine booster group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Binhui Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangzhou, 510799, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

SARS-CoV-2 inactivated vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 8, 2023
• Study Start: July 13, 2022
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: July 28, 2025

Record last verified: 2023-01

Locations

CN (1)