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

NCT05465902 | Withdrawn Phase 2

• 1 other identifier: JSVCT149
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19; SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse drug reactions (ADRs)

  Day 0-28 post-boost dose

• GMT and SCR of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2

  Day 14 post-boost dose

Secondary Outcomes (6)

• Incidence of adverse events (AEs)

  Day 0-7 post-boost dose

• Incidence of AEs

  Day 0-28 post-boost dose

• Incidence of serious adverse events (SAEs)

  Day 0 through 6 months post-boost dose

• GMT and SCR of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2

  Day 28, month 3 and month 6 post-boost dose

• GMI of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2

  Day 14, Day 28, month 3 and month 6 post-boost dose

Other Outcomes (1)

• GMT, GMI, and SCR of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2 endemic variants

  Day 14, Day 28, month 3 and month 6 post-boost dose

Study Arms (6)

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)

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

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)

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)

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)

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)

Biological: Viral Vector COVID-19 vaccine (AstraZeneca)

Interventions

Recombinant COVID-19 variant Vaccine (Sf9 Cell) BIOLOGICAL

1dose, Intramuscular Injection

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), Inactivated BIOLOGICAL

1dose, Intramuscular Injection

Inactivated COVID-19 vaccines cohort group 2

mRNA COVID-19 vaccine (Moderna) BIOLOGICAL

1dose, Intramuscular Injection

mRNA COVID-19 vaccines cohort group 2

Viral Vector COVID-19 vaccine (AstraZeneca) BIOLOGICAL

1dose, Intramuscular Injection

Viral Vector COVID-19 vaccines cohort group 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily sign the ICF approved by the Ethics Committee and agree to participate in the study before any study procedure.
• \. Healthy males or females able to provide legal identification, aged 18 years and above at the time of signing ICF.
• \. 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.
• \. Able to communicate well with the investigator, and able to understand and comply with the requirements of this clinical trial.
• \. 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).
• \. Axillary temperature \<37.3℃.

You may not qualify if:

• \. Positive SARS-CoV-2 RT-PCR at screening.
• \. Prior medical history of Serve Acute Respiratory Syndromes (SARS), Middle East Respiratory Syndrome (MERS) and other human coronavirus infections or diseases.
• \. Prior history or family history of convulsion, epilepsy, encephalopathy and psychosis.
• \. Fear of needles.
• \. Pregnant or lactating females or those who plan to become pregnant or donate eggs during study period.
• \. 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..
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. Asplenia or functional asplenia.
• \. 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.
• \. Having received immunoglobulins and/or blood products within 3 months prior to administration of this investigational vaccine.
• \. History of tuberculosis treatment or currently on antikoch's treatment for tuberculosis, whether pulmonary or extrapulmonary.

Sponsors & Collaborators

• WestVac Biopharma Co., Ltd.: lead

Study Sites (1)

Clínica de Enfermedades Crónicas y de Procedimientos Especiales, S.C.

Morelia, Michoacán, 58290, Mexico

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines; CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 20, 2022
• Study Start: July 7, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 1, 2024
• Last Updated: March 28, 2025

Record last verified: 2024-03

Locations

ME (1)