COVID-19Phase 2NCT05770180

Phase II Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell)

A Phase 2 study testing Recombinant COVID-19 variant vaccine (Sf9 cell), Recombinant COVID-19 vaccine (CHO cell) and Recombinant COVID-19 vaccine (Sf9 cell) in people with COVID-19, run by WestVac Biopharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A single-center, randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of booster vaccination of Recombinant COVID-19 variant vaccine (Sf9 cell) in healthy people aged 18 years and older after completing 2 or 3 doses of novel coronavirus inactivated vaccine (Vero cells) Read more about this study

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Recombinant COVID-19 variant vaccine (Sf9 cell), Recombinant COVID-19 vaccine (CHO cell) and Recombinant COVID-19 vaccine (Sf9 cell)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: 1 siteChina
Study dates: 30 Mar 2023to 9 Apr 2024
Phase: Phase 2
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 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

At the age of 18 or above, consent to participate in the study by voluntarily signing an ICF approved by the Ethics Committee prior to the commencement of any study procedure;
Subjects qualified for immunization with this product after medical history, physical examination and clinical judgment of health;
Completion of 2 /3 doses of inactivated novel coronavirus vaccine ≥3 months;
The subject is able and willing to comply with the requirements of the clinical trial protocol and can complete the study follow-up for approximately 12 months;
Armpit body temperature < 37.3℃;
Female non-pregnancy period (pregnancy test results are negative), non-lactation period;

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Fertile women (WOCBP) subjects had taken effective contraceptive measures 1 month before enrollment;
WOCBP subjects and male subjects have no pregnancy plans from the screening period to 6 months after the last dose of immunization, and agree to take effective contraceptive measures from the screening visit to 6 months after the last dose of immunization;
WOCBP subjects and male subjects agree not to donate eggs (oocytes, oocytes) for assisted reproduction (WOCBP subjects) or to refrain from sperm donation (male subjects) for a period of 6 months from screening visit to the last dose of immunization.

Who cannot join

Positive results of SARS-CoV-2 RT-PCR within 24 hours;
The subject has a history of SARS-CoV-2 infection within 3 months;
The anti-SARS-CoV-2 IgM antibody was positive during the screening period.
History of human coronavirus infection or disease with severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS), etc.;
Previous history of convulsion, epilepsy, encephalopathy or psychosis or family history;
Needle fainter;

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Those who plan to become pregnant or donate sperm or eggs during the trial period (within 6 months after exemption);
Previous history of allergic reaction or allergic reaction to any vaccine and its excipients, such as allergy, urticaria, severe eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.;
Received subunit or inactivated vaccine within 14 days or live attenuated vaccine within 1 month prior to receiving the experimental vaccine;
Participating in any other interventional test device or drug study within 30 days prior to screening, or currently using another investigational drug or within 5 half-life after the last administration of the study drug;
A genetic tendency to hemorrhage or coagulation abnormalities (such as cytokine defects, coagulation disorders or platelet disorders), or a history of severe bleeding, or a history of excessive bleeding or ecchymosis following intramuscular injection or venipuncture;
Confirmation of diseases affecting the functioning of the immune system, including cancer, congenital or acquired immunodeficiency (e.g., human immunodeficiency virus (HIV) infection), uncontrolled autoimmune diseases, based on known medical history or diagnosis;
There are serious or uncontrollable respiratory diseases, cardiovascular diseases, nervous system diseases, blood and lymphatic system diseases, liver and kidney diseases, metabolic and skeletal system diseases that affect the evaluation of the results of this study as determined by the researchers;
Anplenia or functional anplenia;
Long-term use (continuous use ≥14 days) of immunosuppressants or other immunomodulatory drugs (such as corticosteroids: prednisone or similar drugs) within the 6 months prior to the study vaccine, but topical use (such as ointment, eye drops, inhalants or nasal spray) is permitted, and the topical use shall not exceed the dosage recommended in the instructions or any systemic signs of exposure;
Received immunoglobulin and/or blood products in the three months prior to receiving the study vaccine;
Patients undergoing anti-tuberculosis treatment;
Medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Provincial Center for Disease Prevention and Control
Nanjing

Other trials in China

About this study

Official title: A Single-center, Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Booster Vaccination of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) in Healthy People Aged 18 Years and Older

Read the detailed description

two dose level of Recombinant COVID-19 variant vaccine (Sf9 cell) compete with Recombinant COVID-19 vaccine (CHO cell) and Recombinant COVID-19 vaccine (Sf9 cell) .

Conditions: COVID-19
Being tested: Recombinant COVID-19 variant vaccine (Sf9 cell), Recombinant COVID-19 vaccine (CHO cell), Recombinant COVID-19 vaccine (Sf9 cell)
Medical subject headings: COVID-19

What participants receive

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

Recombinant COVID-19 variant vaccine (Sf9 cell)Biological
WSK-V102
Recombinant COVID-19 vaccine (CHO cell)Biological
control 1
Recombinant COVID-19 vaccine (Sf9 cell)Biological
control 2

Study groups in NCT05770180
Study group	Role	What they receive
low dose test group	Experimental	one dose, Day 0 Receives: Biological: Recombinant COVID-19 variant vaccine (Sf9 cell)
high dose test group	Experimental	one dose, Day 0 Receives: Biological: Recombinant COVID-19 variant vaccine (Sf9 cell)
control group 1	Active comparator	one dose, Day 0 Receives: Biological: Recombinant COVID-19 vaccine (CHO cell)
control group 2	Active comparator	one dose, Day 0 Receives: Biological: Recombinant COVID-19 vaccine (Sf9 cell)

What is being measured

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

solicited adverse events (AE)
Incidence of solicited adverse events (AE) within 14 days after vaccination
Measured: within 14 days after vaccination
Primary Immunogenic indicator
Geometric Mean Titer (GMT) of neutralizing Antibodies against SARS-CoV-2 Prototype and Omicron Variant 14 days after vaccination
Measured: 14 days after vaccination

Secondary outcomes (5)

unsolicited adverse events
Incidence of unsolicited adverse events (AE) 0-30 days after vaccination
Measured: 0-30 days after vaccination
SAE
Incidence of serious adverse events (SAE), adverse events of Special Concern (AESI), and adverse events requiring medical attention (MAAE) within 12 months after vaccination
Measured: within 12 months after vaccination
GMT
Geometric mean Titer (GMT) of neutralizing Antibodies against SARS-CoV-2 prototype Strain and Omicron Variant Strain
Measured: 30 days, 3 months and 6 months after vaccination
GMI
Geometric mean growth multiple (GMI) of neutralizing antibody against SARS-CoV-2 prototype strain
Measured: 14, day 30, 3 and 6 months after vaccination
binding antibodies
Geometric Mean Titer (GMT) and Geometric mean Titer Increase Factor (GMI) of IgG Antibody against SARS-CoV-2 S-RBD protein
Measured: 14, day 30, 3 and 6 months after vaccination

Timeline

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

30 Mar 20239 Apr 2024

First posted15 Mar 2023
Study start30 Mar 2023
Primary completion30 Jul 2023
Study completion9 Apr 2024

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: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05770180
Sponsor's protocol ID: WSKCT002
Status last verified: Jul 2024
First submitted: 10 Mar 2023
Last updated: 24 Jul 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Booster Vaccination of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) in Healthy People Aged 18 Years and Older
ClinicalTrials.gov ID: NCT05770180
Acronym / sponsor ID: WSKCT002
Conditions: COVID-19
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Mar 2023 (actual)
Primary completion: 30 Jul 2023 (actual)
Study completion: 9 Apr 2024 (actual)
First posted: 15 Mar 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.

Detailed description

two dose level of Recombinant COVID-19 variant vaccine (Sf9 cell) compete with Recombinant COVID-19 vaccine (CHO cell) and Recombinant COVID-19 vaccine (Sf9 cell) .

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
low dose test group	Experimental	Biological: Recombinant COVID-19 variant vaccine (Sf9 cell)one dose, Day 0
high dose test group	Experimental	Biological: Recombinant COVID-19 variant vaccine (Sf9 cell)one dose, Day 0
control group 1	Active comparator	Biological: Recombinant COVID-19 vaccine (CHO cell)one dose, Day 0
control group 2	Active comparator	Biological: Recombinant COVID-19 vaccine (Sf9 cell)one dose, Day 0

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

At the age of 18 or above, consent to participate in the study by voluntarily signing an ICF approved by the Ethics Committee prior to the commencement of any study procedure;
Subjects qualified for immunization with this product after medical history, physical examination and clinical judgment of health;
Completion of 2 /3 doses of inactivated novel coronavirus vaccine ≥3 months;
The subject is able and willing to comply with the requirements of the clinical trial protocol and can complete the study follow-up for approximately 12 months;
Armpit body temperature < 37.3℃;

Key exclusion criteria (18 listed)

Positive results of SARS-CoV-2 RT-PCR within 24 hours;
The subject has a history of SARS-CoV-2 infection within 3 months;
The anti-SARS-CoV-2 IgM antibody was positive during the screening period.
History of human coronavirus infection or disease with severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS), etc.;
Previous history of convulsion, epilepsy, encephalopathy or psychosis or family history;

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
Recombinant COVID-19 variant vaccine (Sf9 cell)WSK-V102	Biological	high dose test group, low dose test group
Recombinant COVID-19 vaccine (CHO cell)control 1	Biological	control group 1
Recombinant COVID-19 vaccine (Sf9 cell)control 2	Biological	control group 2

Primary outcome

solicited adverse events (AE)
Time frame: within 14 days after vaccination
Incidence of solicited adverse events (AE) within 14 days after vaccination
Primary Immunogenic indicator
Time frame: 14 days after vaccination
Geometric Mean Titer (GMT) of neutralizing Antibodies against SARS-CoV-2 Prototype and Omicron Variant 14 days after vaccination

5 secondary outcomes

unsolicited adverse events
Time frame: 0-30 days after vaccination
SAE
Time frame: within 12 months after vaccination
GMT
Time frame: 30 days, 3 months and 6 months after vaccination
GMI
Time frame: 14, day 30, 3 and 6 months after vaccination
binding antibodies
Time frame: 14, day 30, 3 and 6 months after vaccination

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Individual participant dataSharing planned: No

Related trials for COVID-19

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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?

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 9 inclusion and 18 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: finished, as of the sponsor's last update on 24 Jul 2024. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

solicited adverse events (AE) (time frame: within 14 days after vaccination). The study lists 2 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 NCT05770180.

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 24 Jul 2024.