COVID-19Phase 1NCT05765604
Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) (WSK-V102)
A Phase 1 study testing Recombinant COVID-19 variant vaccine(Sf9 cell) and Recombinant COVID-19 vaccine(CHO cell) in people with COVID-19, run by WestVac Biopharma Co., Ltd. at 1 site in China.
Trial summary
Subjects aged 18 and above who have been completed primary or booster vaccination of COVID-19 inactivated vaccines for 3 months or more, to conduct a randomized, parallel controlled, double-blind, single-center phase I clinical trial of Recombinant variant COVID-19 vaccine (Sf9 cell)(WSK-V102) to evaluate the safety… 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) and Recombinant COVID-19 vaccine(CHO cell)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2023to 30 Mar 2024
- Phase
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and above.
- Obtain the subject's informed consent and sign the informed consent form.
- The subject is able and willing to comply with the requirements of the clinical trial protocol and is willing and able to comply with all study plan contents and other requirements of the study.
- Armpit body temperature < 37.3℃.
- People who have had basic or enhanced immunization with COVID-19 vaccine for 3 months or more;
- SARS-CoV-2 nucleic acid screening was negative in the last 24 hours.
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- Anti-sars-cov-2 IgM antibody was negative during the screening period.
- BMI of 18.5-30.0 kg/m2.
- Women's non-pregnancy period (pregnancy test results are negative), non-lactation period.
- Fertile Women (WOCBP) subjects had taken effective contraceptive measures 1 month before enrollment.
- WOCBP subjects and male subjects, who do not plan to become pregnant for 6 months from the screening period to the last dose of immunization, agree to take effective contraceptive measures for 6 months from the screening visit to 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.
- Subjects eligible for immunization with this product after medical history, physical examination and clinical judgment of health.
Who cannot join
- Have cancer; Or have other serious chronic diseases such as uncontrolled asthma, diabetes, liver and kidney disease, thyroid disease, convulsions, epilepsy and other neurological/psychiatric disorders.
- have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia or other autoimmune disease;
- Those who are allergic to any component of the experimental vaccine have had a history of severe vaccine allergic reaction in the past.
- History of SARS or MERS or SARS-CoV-2 infection/illness within 3 months.
- Patients with more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension that cannot be controlled by drugs.
- Congenital or acquired angioedema/neuroedema.
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- Urticaria in the year prior to receiving the experimental vaccine.
- asplenia or functional asplenia.
- Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications).
- Needle fainter.
- Immunosuppressive therapy, antiallergy therapy, cytotoxic therapy, and inhaled corticosteroids (excluding corticosteroid spray for allergic rhinitis and topical corticosteroids for acute non-concurrent dermatitis) for 14 or more days within 6 months prior to receiving the experimental vaccine.
- Received blood products within 3 months prior to receiving the trial vaccine.
- Received other investigational drugs within 1 month prior to receiving the experimental vaccine.
- Received subunit or inactivated vaccine within 14 days or live attenuated vaccine within 1 month prior to receiving the experimental vaccine.
- are receiving anti-TB 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.
About this study
Official title: A Randomized, Parallel Controlled, Double-blind, Single-center Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell)(WSK-V102) in People Aged 18 Years or Older
Subjects aged 18 and above who have been completed primary or booster vaccination of COVID-19 inactivated vaccines for 3 months or more, to conduct a randomized, parallel controlled, double-blind, single-center phase I clinical trial of Recombinant variant COVID-19 vaccine (Sf9 cell)(WSK-V102) to evaluate the safety, tolerance and immunogenicity of this vaccine in the study population.
Read the detailed description
Low and high doses of study vaccine were compared with control groups to evaluate the safety and immunogenicity of the study vaccine.
- Conditions
- COVID-19
- Being tested
- Recombinant COVID-19 variant vaccine(Sf9 cell), Recombinant COVID-19 vaccine(CHO 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
IM
Recombinant COVID-19 vaccine(CHO cell)Biological
IM
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | low dose and high dose, only one dose at day 0 Receives: Biological: Recombinant COVID-19 variant vaccine(Sf9 cell) |
| control group | Active comparator | one dose at day 0 Receives: Biological: Recombinant COVID-19 vaccine(CHO 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)
Measured: 0-14 days after vaccination
Secondary outcomes (5)
laboratory safety
Changes in laboratory tests on day 3 after vaccination
Measured: 3 days after vaccination
safety outcome
Incidence of unsolicited adverse events (AE) and serious adverse events (SAE)
Measured: 30 days after vaccination,12 months after vaccination
binding antibodies
Geometric mean Titer (GMT) and Geometric mean growth multiple (GMFI) of S-RBD protein-specific antibodies (ELISA) against SARS-CoV-2
Measured: 14 days, 30 days, 3 months and 6 months
neutralizing antibodies
Geometric mean Titer (GMT) and Geometric mean growth multiple (GMFI) of neutralizing antibodies against SARS-CoV-2 prototype strain and Omicron variant strain (according to the prevailing strain)
Measured: 14 days, 30 days, 3 months and 6 months
cellular immune
ELISpot was used to detect the cell frequencies of IFN-γ and IL-2 secreted by SARS-CoV-2 S-RBD protein
Measured: 14 days and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start14 Mar 2023
- Primary completion30 Jul 2023
- Study completion30 Mar 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- WestVac Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765604
- Sponsor's protocol ID
- WSKCT001
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Controlled, Double-blind, Single-center Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell)(WSK-V102) in People Aged 18 Years or Older
- ClinicalTrials.gov ID
- NCT05765604
- Acronym / sponsor ID
- WSKCT001
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 13 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.
Subjects aged 18 and above who have been completed primary or booster vaccination of COVID-19 inactivated vaccines for 3 months or more, to conduct a randomized, parallel controlled, double-blind, single-center phase I clinical trial of Recombinant variant COVID-19 vaccine (Sf9 cell)(WSK-V102) to evaluate the safety, tolerance and immunogenicity of this vaccine in the study population.
Detailed description
Low and high doses of study vaccine were compared with control groups to evaluate the safety and immunogenicity of the study vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Biological: Recombinant COVID-19 variant vaccine(Sf9 cell)low dose and high dose, only one dose at day 0 |
| control group | Active comparator | Biological: Recombinant COVID-19 vaccine(CHO cell)one dose at day 0 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 and above.
- Obtain the subject's informed consent and sign the informed consent form.
- The subject is able and willing to comply with the requirements of the clinical trial protocol and is willing and able to comply with all study plan contents and other requirements of the study.
- Armpit body temperature < 37.3℃.
- People who have had basic or enhanced immunization with COVID-19 vaccine for 3 months or more;
Key exclusion criteria (16 listed)
- Have cancer; Or have other serious chronic diseases such as uncontrolled asthma, diabetes, liver and kidney disease, thyroid disease, convulsions, epilepsy and other neurological/psychiatric disorders.
- have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia or other autoimmune disease;
- Those who are allergic to any component of the experimental vaccine have had a history of severe vaccine allergic reaction in the past.
- History of SARS or MERS or SARS-CoV-2 infection/illness within 3 months.
- Patients with more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension that cannot be controlled by drugs.
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)IM | Biological | test group |
| Recombinant COVID-19 vaccine(CHO cell)IM | Biological | control group |
Primary outcome
solicited adverse events (AE)
Time frame: 0-14 days after vaccination
Incidence of solicited adverse events (AE)
5 secondary outcomes
laboratory safety
Time frame: 3 days after vaccination
safety outcome
Time frame: 30 days after vaccination,12 months after vaccination
binding antibodies
Time frame: 14 days, 30 days, 3 months and 6 months
neutralizing antibodies
Time frame: 14 days, 30 days, 3 months and 6 months
cellular immune
Time frame: 14 days and 3 months
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 26 Mar 2025.
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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 Phase 1 study testing Recombinant COVID-19 variant vaccine(Sf9 cell) and Recombinant COVID-19 vaccine(CHO cell) in people with COVID-19, run by WestVac Biopharma 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 13 inclusion and 16 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 26 Mar 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: 0-14 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2025.