COVID-19NCT06381843

A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster

A study testing Recombinant COVID-19 Vaccine (Sf9 Cell) and COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19 and SARS-CoV-2 Infection, 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

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19, SARS-CoV-2 Infection
What is being tested?: Recombinant COVID-19 Vaccine (Sf9 Cell) and COVID-19 Vaccine (Vero Cell), Inactivated
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 2 Aug 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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

(1) Aged 18-60 years old, voluntarily sign the ICF approved by the ethics committee before any research procedure begins, and agree to participate in this research;
(2) Subjects who are in line with the immunization of this product after medical history, physical examination and clinical judgment are healthy;
(3) Participate in this clinical trial after completing 3 doses of immunization ≥ 6 months (calculated based on the date of the last vaccination as 0) in accordance with the domestically approved inactivated vaccine vaccination program, and can provide relevant vaccination certificates;
(4) The subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up of about 12 months;
(5) Males and females of childbearing age who are fertile voluntarily use effective contraceptive measures (such as condoms, intrauterine devices, spermicides) from the signing of the informed letter to 6 months after the completion of vaccination, and contraceptive use is not allowed medicine. Female subjects had a negative pregnancy test and agreed not to breastfeed during the study period and for at least 3 months after vaccination with the experimental vaccine.
(6) Underarm body temperature <37.3℃.

Who cannot join

(1) Positive SARS-CoV-2 RT-PCR test at screening;
(2) A history of human coronavirus infection or disease history such as novel coronavirus (SARS-CoV-2), severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS);
(3) Those with previous medical history or family history of convulsions, epilepsy, encephalopathy or mental illness;
(4) Persons with fainting needles;
(5) Those who plan to become pregnant or perform sperm and egg donation during the trial period;
(6) History of allergy or allergic reaction to any vaccine and its excipients, such as: allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, angioedema, etc.;

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(7) Have received any vaccine within 30 days before vaccination of this research vaccine or plan to receive any other vaccine other than this research vaccine during this research;
(8) Participate in any other interventional experimental device or drug research within 30 days before screening, or are currently using other experimental drugs or within 5 half-lives after the last administration of the research drug;
(9) Hereditary bleeding tendency or abnormal coagulation function (such as cytokine deficiency, coagulation disorder or platelet disorder), or a history of severe bleeding, or a history of massive bleeding or ecchymosis after intramuscular injection or venipuncture;
(10) According to known medical history or diagnosis, it is confirmed to have diseases that affect the function of the immune system, including cancer, congenital or acquired immunodeficiency (eg: human immunodeficiency virus (HIV) infection), uncontrolled autoimmune diseases;
(11) There are serious or uncontrollable diseases of the respiratory system, cardiovascular diseases, nervous system diseases, blood and lymphatic system diseases, liver and kidney diseases, metabolic and skeletal diseases that are judged by the investigator to affect the evaluation of the results of this study;
(12) Asplenia or functional asplenia;
(13) Long-term use (≥14 days of continuous use) of immunosuppressive drugs or other immunomodulatory drugs (such as corticosteroids: prednisone or similar drugs) within 6 months before the vaccine for this trial, but topical drugs are allowed ( Such as ointment, eye drops, inhalation or nasal spray), topical application should not exceed the dose recommended in the instructions or have any signs of systemic exposure;
(14) Received immunoglobulin and/or blood products within 3 months before the vaccine for this trial;
(15) Patients undergoing anti-tuberculosis treatment;
(16) According to the judgment of the investigator, due to various medical, psychological, social or other conditions, it is contrary to the experimental protocol, or affects the subject's signing of informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital of Sichuan University
Chengdu, Sichuan

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster in People Aged 18-60 Years

A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation.

A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated.

Conditions: COVID-19, SARS-CoV-2 Infection
Being tested: Recombinant COVID-19 Vaccine (Sf9 Cell), COVID-19 Vaccine (Vero Cell), Inactivated
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
1dose, Intramuscular Injection
COVID-19 Vaccine (Vero Cell), InactivatedBiological
1dose, Intramuscular Injection

Study groups in NCT06381843
Study group	Role	What they receive
Recombinant COVID-19 Vaccine (Sf9 Cell)	Experimental	Participants who received 3 doses of Inactivated COVID-19 vaccines with the third dose at least 6 months (≥180 days) prior to enrolment. N=60 Intervention: Recombinant COVID-19 Vaccine (Sf9 Cell) Receives: Biological: Recombinant COVID-19 Vaccine (Sf9 Cell)
Inactivated COVID-19 vaccines	Active comparator	Participants who received 3 doses of Inactivated COVID-19 vaccines with the third dose at least 6 months (≥180 days) prior to enrolment. N=60 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated

What is being measured

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

Incidence of adverse drug reactions (ADRs)
Measured: Day 0-30 post-boost dose.
Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain
Measured: Day 30 post-boost dose.
Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant
Measured: Day 30 post-boost dose.

Secondary outcomes (5)

Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain
Measured: Day 30 post-boost dose.
Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant
Measured: Day 30 post-boost dose.
GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain
Measured: Day 7, day 14, month 3 and month 6 after the booster dose.
GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant
Measured: Day 7, day 14, month 3 and month 6 after the booster dose.
GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD
Measured: Day 7, day 14, day 30, month 3 and month 6 after the booster dose.

Timeline

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

2 Aug 202230 Dec 2023

First posted24 Apr 2024
Study start2 Aug 2022
Primary completion29 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06381843
Sponsor's protocol ID: WSKCT004
Status last verified: Mar 2024
First submitted: 23 Apr 2024
Last updated: 25 Apr 2024
Results posted: No
Data monitoring committee: 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?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster in People Aged 18-60 Years
ClinicalTrials.gov ID: NCT06381843
Acronym / sponsor ID: WSKCT004
Conditions: COVID-19, SARS-CoV-2 Infection
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: West China Hospital
Study start: 2 Aug 2022 (actual)
Primary completion: 29 Mar 2023 (actual)
Study completion: 30 Dec 2023 (actual)
First posted: 24 Apr 2024 (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: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Recombinant COVID-19 Vaccine (Sf9 Cell)	Experimental	Biological: Recombinant COVID-19 Vaccine (Sf9 Cell)Participants who received 3 doses of Inactivated COVID-19 vaccines with the third dose at least 6 months (≥180 days) prior to enrolment. N=60 Intervention: Recombinant COVID-19 Vaccine (Sf9 Cell)
Inactivated COVID-19 vaccines	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), InactivatedParticipants who received 3 doses of Inactivated COVID-19 vaccines with the third dose at least 6 months (≥180 days) prior to enrolment. N=60 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

(1) Aged 18-60 years old, voluntarily sign the ICF approved by the ethics committee before any research procedure begins, and agree to participate in this research;
(2) Subjects who are in line with the immunization of this product after medical history, physical examination and clinical judgment are healthy;
(3) Participate in this clinical trial after completing 3 doses of immunization ≥ 6 months (calculated based on the date of the last vaccination as 0) in accordance with the domestically approved inactivated vaccine vaccination program, and can provide relevant vaccination certificates;
(4) The subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up of about 12 months;
(5) Males and females of childbearing age who are fertile voluntarily use effective contraceptive measures (such as condoms, intrauterine devices, spermicides) from the signing of the informed letter to 6 months after the completion of vaccination, and contraceptive use is not allowed medicine. Female subjects had a negative pregnancy test and agreed not to breastfeed during the study period and for at least 3 months after vaccination with the experimental vaccine.

Key exclusion criteria (16 listed)

(1) Positive SARS-CoV-2 RT-PCR test at screening;
(2) A history of human coronavirus infection or disease history such as novel coronavirus (SARS-CoV-2), severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS);
(3) Those with previous medical history or family history of convulsions, epilepsy, encephalopathy or mental illness;
(4) Persons with fainting needles;
(5) Those who plan to become pregnant or perform sperm and egg donation during the trial period;

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)1dose, Intramuscular Injection	Biological	Recombinant COVID-19 Vaccine (Sf9 Cell)
COVID-19 Vaccine (Vero Cell), Inactivated1dose, Intramuscular Injection	Biological	Inactivated COVID-19 vaccines

Primary outcome

Incidence of adverse drug reactions (ADRs)
Time frame: Day 0-30 post-boost dose.
Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain
Time frame: Day 30 post-boost dose.
Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant
Time frame: Day 30 post-boost dose.

5 secondary outcomes

Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain
Time frame: Day 30 post-boost dose.
Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant
Time frame: Day 30 post-boost dose.
GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain
Time frame: Day 7, day 14, month 3 and month 6 after the booster dose.
GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant
Time frame: Day 7, day 14, month 3 and month 6 after the booster dose.
GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD
Time frame: Day 7, day 14, day 30, month 3 and month 6 after the booster dose.

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 25 Apr 2024.
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?

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 6 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 25 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?

Incidence of adverse drug reactions (ADRs) (time frame: Day 0-30 post-boost dose.). The study lists 3 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 NCT06381843.

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 25 Apr 2024.