COVID-19Phase 2NCT05465902

Safety and Immunogenicity of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) as a Booster

A Phase 2 study testing Recombinant COVID-19 variant Vaccine (Sf9 Cell), COVID-19 Vaccine (Vero Cell), Inactivated and mRNA COVID-19 vaccine (Moderna) in people with COVID-19 and SARS-CoV-2 Infection, run by WestVac Biopharma Co., Ltd. at 1 site in Mexico.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial. The study plans to enroll subjects who have completed homologous primary vaccination with either inactivated or mRNA or Viral Vector COVID-19 vaccines (one or two doses) and have not been infected with COVID-19. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19, SARS-CoV-2 Infection
What is being tested?: Recombinant COVID-19 variant Vaccine (Sf9 Cell), COVID-19 Vaccine (Vero Cell), Inactivated and mRNA COVID-19 vaccine (Moderna)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteMexico
Study dates: 7 Jul 2023to Dec 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 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Voluntarily sign the ICF approved by the Ethics Committee and agree to participate in the study before any study procedure.
2. Healthy males or females able to provide legal identification, aged 18 years and above at the time of signing ICF.
3. Subjects who have completed homologous primary vaccination with either Inactivated or mRNA or Viral Vector COVID-19 vaccines (full approval, CMA or EUA) and have the last dose administered 6 months ago or earlier from the date of signing the ICF for the study. Those who have received combined immunization with two doses of vaccines should be excluded.
4. Able to communicate well with the investigator, and able to understand and comply with the requirements of this clinical trial.
5. Males with female sexual partners or females of childbearing potential voluntarily take effective contraceptive methods from signing ICF to 3 months after the vaccination, including sexual abstinence or effective contraceptive measures (e.g., intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, intrauterine device (IUD), condoms (male), diaphragm, and cervical cap).
6. Axillary temperature <37.3℃.

Who cannot join

1. Positive SARS-CoV-2 RT-PCR at screening.
2. Prior medical history of Serve Acute Respiratory Syndromes (SARS), Middle East Respiratory Syndrome (MERS) and other human coronavirus infections or diseases.
3. Prior history or family history of convulsion, epilepsy, encephalopathy and psychosis.
4. Fear of needles.
5. Pregnant or lactating females or those who plan to become pregnant or donate eggs during study period.
6. Prior history of allergic reaction or anaphylaxis to any vaccine or its excipients, e.g., hypersensitivity, urticaria, serious eczema, dyspnea, laryngeal edema, and angioedema etc..

Show all 19Show fewer

7. Prior use of any vaccine within 28 days before receiving this investigational vaccine or planning to use any vaccine other than this investigational vaccine during the study period.
8. Participation in studies of any other interventional device or drug within 28 days before the screening, or current treatment with other investigational drug(s) or within 5 half-lives after taking the last dose of the study drug.
9. Hereditary hemorrhagic tendency or coagulation dysfunction (e.g., clotting factors deficiency, coagulation disorders or platelet disorders), or a history of severe bleeding, or a history of massive bleeding after intramuscular injection or venipuncture, or a history of ecchymosis.
10. Known medical history or diagnosis confirming that subjects have diseases affecting immune system function, including cancer, congenital or acquired immunodeficiency (e.g., infection with Human Immunodeficiency Virus (HIV)), or uncontrolled autoimmune disease.
11. Serious or uncontrolled respiratory system disorders, cardiovascular disorders, nervous system disorders, blood and lymphatic system disorders, liver and kidney disorders, metabolism and skeletal disorders, etc. influencing study results evaluation at the investigator's discretion.
12. Asplenia or functional asplenia.
13. Long-term use (continuous use for ≥14 days) of immunosuppressants or other immunomodulators (e.g., glucocorticoids: prednisone or equivalents) within 6 months prior to administration of this investigational vaccine, except for topical medications (e.g., ointments, eye drops, inhalants or nasal sprays). And the topical medications should not exceed the recommended dose in the labels or induce any signs of systemic exposure.
14. Having received immunoglobulins and/or blood products within 3 months prior to administration of this investigational vaccine.
15. History of tuberculosis treatment or currently on antikoch's treatment for tuberculosis, whether pulmonary or extrapulmonary.
16. Suspected or known alcohol dependency or drug abuse, which may affect safety evaluation or subject's compliance at the investigator's discretion.
17. Planning to permanently move from the local area before study completion or leave the local area for a long time during the period of study visits.
18. An employee of the study site, Sponsor and contract research organization (CRO) taking part in the study.
19. Other conditions unsuitable for this study at the investigator's discretion.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Clínica de Enfermedades Crónicas y de Procedimientos Especiales, S.C.
Morelia, Michoacán, 58290

Other trials in Mexico

About this study

Official title: Safety and Immunogenicity of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) as a Booster Following Primary Vaccination of Either Inactivated or mRNA or Viral Vector COVID-19 Vaccines

This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial.

Read the detailed description

This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial.

The study plans to enroll subjects who have completed homologous primary vaccination with either inactivated or mRNA or Viral Vector COVID-19 vaccines (one or two doses) and have not been infected with COVID-19. All subjects will be evaluated for safety and immunogenicity after a single dose booster immunization with Recombinant COVID-19 variant Vaccine (Sf9 Cell) or inactivated COVID-19 vaccine (Vero cell) or mRNA vaccine or Viral Vector vaccine. The study plans to enroll about 600 subjects aged 18 years and above (subjects aged ≥ 60 years account for approximately 10%) that would be divided into three cohorts according to different primary vaccination: Inactivated COVID-19 vaccines cohort, mRNA COVID-19 vaccines cohort and Viral Vector COVID-19 vaccines cohort, with approximately 200 cases in each cohort. The subjects will be randomized to the Recombinant COVID-19 variant Vaccine (Sf9 Cell) group (test group) or the inactivated COVID-19 vaccine (Vero cell) group or mRNA vaccine or Viral Vector vaccine (control group) in a ratio of 1:1.

Conditions: COVID-19, SARS-CoV-2 Infection
Being tested: Recombinant COVID-19 variant Vaccine (Sf9 Cell), COVID-19 Vaccine (Vero Cell), Inactivated, mRNA COVID-19 vaccine (Moderna), Viral Vector COVID-19 vaccine (AstraZeneca)
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
1dose, Intramuscular Injection
COVID-19 Vaccine (Vero Cell), InactivatedBiological
1dose, Intramuscular Injection
mRNA COVID-19 vaccine (Moderna)Biological
1dose, Intramuscular Injection
Viral Vector COVID-19 vaccine (AstraZeneca)Biological
1dose, Intramuscular Injection

Study groups in NCT05465902
Study group	Role	What they receive
Inactivated COVID-19 vaccines cohort group 1	Experimental	Participants who received 2 doses of Inactivated COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment, N=100 Intervention: Recombinant COVID-19 variant Vaccine (Sf9 Cell) Receives: Biological: Recombinant COVID-19 variant Vaccine (Sf9 Cell)
Inactivated COVID-19 vaccines cohort group 2	Active comparator	Participants who received 2 doses of Inactivated COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment, N=100 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
mRNA COVID-19 vaccines cohort group 1	Experimental	Participants who received 2 doses of mRNA COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=100 Intervention: Recombinant COVID-19 variant Vaccine (Sf9 Cell) Receives: Biological: Recombinant COVID-19 variant Vaccine (Sf9 Cell)
mRNA COVID-19 vaccines cohort group 2	Active comparator	Participants who received 2 doses of mRNA COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=100 Intervention: mRNA COVID-19 vaccine (Moderna) Receives: Biological: mRNA COVID-19 vaccine (Moderna)
Viral Vector COVID-19 vaccines cohort group 1	Experimental	Participants who received 2 doses of Viral Vector COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=100 Intervention: Recombinant COVID-19 variant Vaccine (Sf9 Cell) Receives: Biological: Recombinant COVID-19 variant Vaccine (Sf9 Cell)
Viral Vector COVID-19 vaccines cohort group 2	Active comparator	Participants who received 2 doses of Viral Vector COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=100 Intervention: Viral Vector COVID-19 vaccine (AstraZeneca) Receives: Biological: Viral Vector COVID-19 vaccine (AstraZeneca)

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 0-28 post-boost dose
GMT and SCR of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2
Measured: Day 14 post-boost dose

Secondary outcomes (6)

Incidence of adverse events (AEs)
Measured: Day 0-7 post-boost dose
Incidence of AEs
Measured: Day 0-28 post-boost dose
Incidence of serious adverse events (SAEs)
Measured: Day 0 through 6 months post-boost dose
GMT and SCR of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2
Measured: Day 28, month 3 and month 6 post-boost dose
GMI of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2
Measured: Day 14, Day 28, month 3 and month 6 post-boost dose
GMT, GMI and SCR of IgG antibodies against Vac2107 of SARS-CoV-2
Measured: Day 14, Day 28, month 3 and month 6 post-boost dose

Timeline

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

7 Jul 2023Dec 2024

First posted20 Jul 2022
Study start7 Jul 2023
Primary completion30 Nov 2024 (estimated)
Study completionDec 2024 (estimated)

Why it stopped: Clinical trials not conducted

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05465902
Sponsor's protocol ID: JSVCT149
Status last verified: Mar 2024
First submitted: 18 Jul 2022
Last updated: 28 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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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Study at a glance

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

Official title: Safety and Immunogenicity of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) as a Booster Following Primary Vaccination of Either Inactivated or mRNA or Viral Vector COVID-19 Vaccines
ClinicalTrials.gov ID: NCT05465902
Acronym / sponsor ID: JSVCT149
Conditions: COVID-19, SARS-CoV-2 Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Clinical trials not conducted
Enrolment: 0 participants (actual)
Lead sponsor: WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 Jul 2023 (actual)
Primary completion: 30 Nov 2024 (estimated)
Study completion: Dec 2024 (estimated)
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, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial.

Detailed description

This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Inactivated COVID-19 vaccines cohort group 1	Experimental	Biological: Recombinant COVID-19 variant Vaccine (Sf9 Cell)Participants who received 2 doses of Inactivated COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment, N=100 Intervention: Recombinant COVID-19 variant Vaccine (Sf9 Cell)
Inactivated COVID-19 vaccines cohort group 2	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), InactivatedParticipants who received 2 doses of Inactivated COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment, N=100 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated
mRNA COVID-19 vaccines cohort group 1	Experimental	Biological: Recombinant COVID-19 variant Vaccine (Sf9 Cell)Participants who received 2 doses of mRNA COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=100 Intervention: Recombinant COVID-19 variant Vaccine (Sf9 Cell)
mRNA COVID-19 vaccines cohort group 2	Active comparator	Biological: mRNA COVID-19 vaccine (Moderna)Participants who received 2 doses of mRNA COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=100 Intervention: mRNA COVID-19 vaccine (Moderna)
Viral Vector COVID-19 vaccines cohort group 1	Experimental	Biological: Recombinant COVID-19 variant Vaccine (Sf9 Cell)Participants who received 2 doses of Viral Vector COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=100 Intervention: Recombinant COVID-19 variant Vaccine (Sf9 Cell)
Viral Vector COVID-19 vaccines cohort group 2	Active comparator	Biological: Viral Vector COVID-19 vaccine (AstraZeneca)Participants who received 2 doses of Viral Vector COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=100 Intervention: Viral Vector COVID-19 vaccine (AstraZeneca)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

1. Voluntarily sign the ICF approved by the Ethics Committee and agree to participate in the study before any study procedure.
2. Healthy males or females able to provide legal identification, aged 18 years and above at the time of signing ICF.
3. Subjects who have completed homologous primary vaccination with either Inactivated or mRNA or Viral Vector COVID-19 vaccines (full approval, CMA or EUA) and have the last dose administered 6 months ago or earlier from the date of signing the ICF for the study. Those who have received combined immunization with two doses of vaccines should be excluded.
4. Able to communicate well with the investigator, and able to understand and comply with the requirements of this clinical trial.
5. Males with female sexual partners or females of childbearing potential voluntarily take effective contraceptive methods from signing ICF to 3 months after the vaccination, including sexual abstinence or effective contraceptive measures (e.g., intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, intrauterine device (IUD), condoms (male), diaphragm, and cervical cap).

Key exclusion criteria (19 listed)

1. Positive SARS-CoV-2 RT-PCR at screening.
2. Prior medical history of Serve Acute Respiratory Syndromes (SARS), Middle East Respiratory Syndrome (MERS) and other human coronavirus infections or diseases.
3. Prior history or family history of convulsion, epilepsy, encephalopathy and psychosis.
4. Fear of needles.
5. Pregnant or lactating females or those who plan to become pregnant or donate eggs during study 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 variant Vaccine (Sf9 Cell)1dose, Intramuscular Injection	Biological	Inactivated COVID-19 vaccines cohort group 1, Viral Vector COVID-19 vaccines cohort group 1, mRNA COVID-19 vaccines cohort group 1
COVID-19 Vaccine (Vero Cell), Inactivated1dose, Intramuscular Injection	Biological	Inactivated COVID-19 vaccines cohort group 2
mRNA COVID-19 vaccine (Moderna)1dose, Intramuscular Injection	Biological	mRNA COVID-19 vaccines cohort group 2
Viral Vector COVID-19 vaccine (AstraZeneca)1dose, Intramuscular Injection	Biological	Viral Vector COVID-19 vaccines cohort group 2

Primary outcome

Incidence of adverse drug reactions (ADRs)
Time frame: Day 0-28 post-boost dose
GMT and SCR of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2
Time frame: Day 14 post-boost dose

6 secondary outcomes

Incidence of adverse events (AEs)
Time frame: Day 0-7 post-boost dose
Incidence of AEs
Time frame: Day 0-28 post-boost dose
Incidence of serious adverse events (SAEs)
Time frame: Day 0 through 6 months post-boost dose
GMT and SCR of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2
Time frame: Day 28, month 3 and month 6 post-boost dose
GMI of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2
Time frame: Day 14, Day 28, month 3 and month 6 post-boost dose
GMT, GMI and SCR of IgG antibodies against Vac2107 of SARS-CoV-2
Time frame: Day 14, Day 28, month 3 and month 6 post-boost dose

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 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?

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 19 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: withdrawn, as of the sponsor's last update on 28 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 Mexico. 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 was withdrawn before enrolling participants, so there are no results.

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 0-28 post-boost dose). 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 NCT05465902.

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 Mar 2025.