COVID-19Early Phase 1NCT05716347

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

A Early Phase 1 study testing the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine in people with COVID-19, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: 13 Jul 2022to 13 Sep 2023
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou, 510799

Other trials in China

About this study

Official title: Safety and Immunogenicity of a Recombinant SARS-CoV-2 S-Trimer Vaccine (CHO Cell) as Booster Shots in Healthy Adults Aged 18-59 Years Who Have Completed Two Doses of Inactivated SARS-CoV-2 Vaccine

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
Being tested: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccineBiological
one booster dose intramuscularly in the deltoid muscle of the upper arm.

Study groups in NCT05716347
Study group	Role	What they receive
the 5 μg recombinant SARS-CoV-2 S-Trimer vaccine booster group	Experimental	Not described Receives: 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	Not described Receives: 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	Not described Receives: Biological: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine
ICV booster group	Active comparator	Not described Receives: Biological: the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Adverse Events
All adverse events within 30 minutes of booster immunization
Measured: within 30 minutes after booster immunization
Incidence of Treatment-Emergent Adverse Events
Solicited local/systemic AEs within 7 days of booster immunization
Measured: within 7 days of booster immunization
Incidence of Treatment-Emergent Adverse Events
Unsolicited local/systemic AEs within 28 days of booster immunization
Measured: 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
Measured: 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
Measured: 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
Measured: On Day 14 and Day 28 after booster immunization

Secondary outcomes (3)

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
Measured: 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
Measured: 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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 202213 Sep 2023

First posted8 Feb 2023
Study start13 Jul 2022
Primary completion13 Sep 2023
Study completion13 Sep 2023

Why it stopped: Company strategy adjustment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05716347
Sponsor's protocol ID: BS033VX-001
Status last verified: Jan 2023
First submitted: 10 Jan 2023
Last updated: 28 Jul 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of a Recombinant SARS-CoV-2 S-Trimer Vaccine (CHO Cell) as Booster Shots in Healthy Adults Aged 18-59 Years Who Have Completed Two Doses of Inactivated SARS-CoV-2 Vaccine
ClinicalTrials.gov ID: NCT05716347
Acronym / sponsor ID: BS033VX-001
Conditions: COVID-19
Phase: Early Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Company strategy adjustment
Enrolment: 80 participants (actual)
Lead sponsor: Binhui Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 13 Jul 2022 (actual)
Primary completion: 13 Sep 2023 (actual)
Study completion: 13 Sep 2023 (actual)
First posted: 8 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (14 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccineone booster dose intramuscularly in the deltoid muscle of the upper arm.	Biological	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

Primary outcome

Incidence of Treatment-Emergent Adverse Events
Time frame: within 30 minutes after booster immunization
All adverse events within 30 minutes of booster immunization
Incidence of Treatment-Emergent Adverse Events
Time frame: within 7 days of booster immunization
Solicited local/systemic AEs within 7 days of booster immunization
Incidence of Treatment-Emergent Adverse Events
Time frame: within 28 days of booster immunization
Unsolicited local/systemic AEs within 28 days of booster immunization
humoral immunogenicity
Time frame: 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
humoral immunogenicity
Time frame: On Day 14 and Day 28 after booster immunization
The Geometric Mean Fold Rises (GMFR) of neutralizing antibody against Delta, Omicron BA.2.2 and Omicron BA.5.2 after the booster immunization
humoral immunogenicity
Time frame: On Day 14 and Day 28 after booster immunization
The seroconversion rate of neutralizing antibody against Delta, Omicron BA.2.2 and Omicron BA.5.2 after the booster immunization

3 secondary outcomes

humoral immunogenicity
Time frame: On 3rd month, 6th month after booster immunization
humoral immunogenicity
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.
Time frame: 12 months

Results and safety

The study was stopped early (reason given: Company strategy adjustment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine in people with COVID-19, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Company strategy adjustment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: within 30 minutes after booster immunization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05716347.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.