Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) (WSK-V102)

NCT05765604 | Completed Phase 1

• 1 other identifier: WSKCT001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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, tolerance and immunogenicity of this vaccine in the study population.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• solicited adverse events (AE)

  Incidence of solicited adverse events (AE)

  0-14 days after vaccination

Secondary Outcomes (5)

• laboratory safety

  3 days after vaccination

• safety outcome

  30 days after vaccination,12 months after vaccination

• binding antibodies

  14 days, 30 days, 3 months and 6 months

• neutralizing antibodies

  14 days, 30 days, 3 months and 6 months

• cellular immune

  14 days and 3 months

Study Arms (2)

test group

EXPERIMENTAL

low dose and high dose, only one dose at day 0

Biological: Recombinant COVID-19 variant vaccine(Sf9 cell)

control group

ACTIVE COMPARATOR

one dose at day 0

Biological: Recombinant COVID-19 vaccine(CHO cell)

Interventions

Recombinant COVID-19 variant vaccine(Sf9 cell) BIOLOGICAL

IM

test group

Recombinant COVID-19 vaccine(CHO cell) BIOLOGICAL

IM

control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• WestVac Biopharma Co., Ltd.: lead

Study Sites (1)

Jiangsu Provincial Center for Disease Control

Taizhou, China

Location

MeSH Terms

Conditions

COVID-19

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 13, 2023
• Study Start: March 14, 2023
• Primary Completion: July 30, 2023
• Study Completion: March 30, 2024
• Last Updated: March 26, 2025

Record last verified: 2024-03

Locations

CN (1)