COVID-19NCT05465785
A Clinical Trial of Immuno-bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell)
A study testing Recombinant COVID-19 vaccine (Sf9 cell) in people with COVID-19 and SARS-CoV-2 Pneumonia, run by WestVac Biopharma Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days . Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Pneumonia
- What is being tested?
- Recombinant COVID-19 vaccine (Sf9 cell)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2022to 30 Dec 2023
- Phase
- Interventional
- 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
- Subjects aged from 18-59 years.
- Signed informed consent forms of the subjects have been obtained.
- Able and willing to comply with the requirements of the clinical trial protocol and able to complete approximately 8 months of study follow-up.
- Axillary temperature < 37.3℃. Subjects who fulfill all the required conditions for receiving the candidate vaccine as established by medical history and physical examination and determined by investigators.
Who cannot join
- Positive SARS-CoV-2 antibodies (IgG or IgM) screening results.
- Positive SARS-CoV-2 Antigen screening results.
- History of COVID-19 vaccination.
- Previously diagnosed with COVID-19 infection.
- History of HIV infection.
- History or family history of convulsion, epilepsy, encephalopathy and psychosis.
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- Allergy to any component of the candidate vaccine, severe allergy to vaccine in the past, and history of allergy.
- Women with positive urine pregnancy test results, pregnant, lactating women, or women who have a pregnancy plan during the study.
- Patients with acute febrile diseases and infectious diseases.
- Patients with a history of SARS.
- Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by drugs, etc.
- Serious chronic diseases or progressive stage of a disease that cannot be steadily controlled, such as asthma, diabetes mellitus, thyroid disease, etc.
- Congenital or acquired angioedema/angioneurotic edema.
- Urticaria 1 year before receiving the candidate vaccine.
- Asplenia or functional asplenia.
- Thrombocytopenia or other coagulation disorders (which may contraindicate intramuscular injection).
- Fear of needles.
- Any immunosuppressant, antiallergic therapy, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months.
- Blood products within 4 months prior to receiving the candidate vaccine.
- Any other investigational medicine(s) within 1 month prior to the candidate vaccine.
- Any live attenuated vaccine within 1 month prior to the candidate vaccine.
- Any subunit vaccine or inactivated vaccine within 14 days prior to the candidate vaccine.
- Receiving antituberculosis treatment.
- Medical, psychological, social or other factors, which in the discretion of the investigators fail to meet the requirements in the trial protocol or affect the subjects to sign the ICFs.
- In this trial, the second/third vaccination may be stopped in some cases. They include systemic allergic reaction, severe hypersensitivity, or intolerable Grade 3 or above ARs after the previous dose of vaccine. If these reactions occur, the subjects should not continue to receive the second/third vaccination.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease Control and Prevention
Huai'an, Jiangsu, 210009
About this study
Official title: A Clinical Trial to Evaluate the Immunogenicity Bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in Healthy Population Aged 18-59 Years
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days .
Read the detailed description
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with vaccination course 0, 21, 42 days. 892 subjects aged 18-59 years are recruited and randomly inoculated in a 1:1 ratio from a pilot or commercial batch of Recombinant COVID-19 Vaccine (Sf9 Cell).
- Conditions
- COVID-19, SARS-CoV-2 Pneumonia
- Being tested
- 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 vaccine (Sf9 cell)Biological
This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified
| Study group | Role | What they receive |
|---|---|---|
| Pilot batch | Experimental | Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21，42. Receives: Biological: Recombinant COVID-19 vaccine (Sf9 cell) |
| Commercial batch | Active comparator | Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21，42. 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.
The incidence of adverse reactions(ARs).
The incidence of ARs within 7 days after each vaccination.
Measured: Day 0 to day 7
Anti-SARS-CoV-2 specific neutralizing antibodies expressed as geometric mean titer (GMT)and seroconversion rate (SCR).
The GMT and SCR of anti-SARS-CoV-2 specific neutralizing antibodies (euvirus) of the subjects on day 30 after the third vaccination.
Measured: Day 72
Secondary outcomes (5)
The incidence of ARs.
The incidence of ARs from Day 0 to Day 72.
Measured: Day 0 to Day 72
The incidence of adverse events (AEs).
The incidence of adverse events (AEs) from Day 0 to Day 72.
Measured: Day 0 to Day 72
The incidence of serious adverse events (SAEs).
The incidence of SAEs from day 0 through 6 months after the third vaccination.
Measured: Day 0 to 6 months after the third vaccination.
The Geometric Mean Fold Increase (GMI) of the anti-SARS-COV-2 specific neutralizing antibody.
The GMI of the anti-SARS-COV-2 specific neutralizing antibody of the subjects on day 30 after the third vaccination.
Measured: Day 72
The Geometric Mean Titre (GMT), Seroconversion Rate (SCR) and GMI of anti-SARS-COV-2 S-RBD Immunoglobulin (IgG) antibody
The GMT, SCR and GMI of anti-SARS-COV-2 S-RBD IgG antibody of the subjects on day 30 after the third vaccination
Measured: Day 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start20 Jul 2022
- Primary completion11 Mar 2023
- Study completion30 Dec 2023
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,000 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
- NCT05465785
- Sponsor's protocol ID
- JSVCT141
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Immunogenicity Bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in Healthy Population Aged 18-59 Years
- ClinicalTrials.gov ID
- NCT05465785
- Acronym / sponsor ID
- JSVCT141
- Conditions
- COVID-19, SARS-CoV-2 Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 11 Mar 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 20 Jul 2022 (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.
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days .
Detailed description
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with vaccination course 0, 21, 42 days. 892 subjects aged 18-59 years are recruited and randomly inoculated in a 1:1 ratio from a pilot or commercial batch of Recombinant COVID-19 Vaccine (Sf9 Cell).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot batch | Experimental | Biological: Recombinant COVID-19 vaccine (Sf9 cell)Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21，42. |
| Commercial batch | Active comparator | Biological: Recombinant COVID-19 vaccine (Sf9 cell)Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21，42. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects aged from 18-59 years.
- Signed informed consent forms of the subjects have been obtained.
- Able and willing to comply with the requirements of the clinical trial protocol and able to complete approximately 8 months of study follow-up.
- Axillary temperature < 37.3℃. Subjects who fulfill all the required conditions for receiving the candidate vaccine as established by medical history and physical examination and determined by investigators.
Key exclusion criteria (25 listed)
- Positive SARS-CoV-2 antibodies (IgG or IgM) screening results.
- Positive SARS-CoV-2 Antigen screening results.
- History of COVID-19 vaccination.
- Previously diagnosed with COVID-19 infection.
- History of HIV infection.
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 vaccine (Sf9 cell)This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified | Biological | Commercial batch, Pilot batch |
Primary outcome
The incidence of adverse reactions(ARs).
Time frame: Day 0 to day 7
The incidence of ARs within 7 days after each vaccination.
Anti-SARS-CoV-2 specific neutralizing antibodies expressed as geometric mean titer (GMT)and seroconversion rate (SCR).
Time frame: Day 72
The GMT and SCR of anti-SARS-CoV-2 specific neutralizing antibodies (euvirus) of the subjects on day 30 after the third vaccination.
5 secondary outcomes
The incidence of ARs.
Time frame: Day 0 to Day 72
The incidence of adverse events (AEs).
Time frame: Day 0 to Day 72
The incidence of serious adverse events (SAEs).
Time frame: Day 0 to 6 months after the third vaccination.
The Geometric Mean Fold Increase (GMI) of the anti-SARS-COV-2 specific neutralizing antibody.
Time frame: Day 72
The Geometric Mean Titre (GMT), Seroconversion Rate (SCR) and GMI of anti-SARS-COV-2 S-RBD Immunoglobulin (IgG) antibody
Time frame: Day 72
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 Apr 2024.
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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 study testing Recombinant COVID-19 vaccine (Sf9 cell) in people with COVID-19 and SARS-CoV-2 Pneumonia, 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 4 inclusion and 25 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 Apr 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.
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?
The incidence of adverse reactions(ARs). (time frame: Day 0 to day 7). 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?
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 Apr 2024.