A Global Phase III Clinical Trial of Recombinant COVID- 19 Vaccine (Sf9 Cells)

NCT ID: NCT04904471

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 39663 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2023-11-01

Brief Summary

This Phase III study is a global multicenter, randomized, double-blind,placebo controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of therecombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who do not have a known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 or SARS-CoV-2 infection.

Detailed Description

This Phase III study is a global multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who do not have a known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 or SARS-CoV-2 infection. All participants will receive three doses of either study vaccine or placebo on Day 0, Day 21, Day 42 in a ratio of 1:1.There will be two cohorts in the study: the efficacy-safety cohort and the efficacy-extended safety-immunogenicity cohort. The efficacy will be evaluated in all vaccinated participants,including population in the efficacy-safety cohort, the efficacy-extended safety immunogenicity cohort. All vaccinated participants will also be followed up to monitor incidence of SAEs, MAAEs and AESIs. The reactogenicity of the vaccine will be evaluated in the efficacy-extended safety-immunogenicity cohort. Approximately 3000 participants will be enrolled into the efficacy-extended safety-immunogenicity cohort. This cohort will undergo additional visits to collect immunogenicity data associated with receiving the recombinant COVID-19 vaccine (Sf9 cells) and to analyze the infection status.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Experimental

Three doses of recombinant SARS-CoV-2 vaccine (Sf9 Cell) on Day 0, Day 21and Day 42.

Group Type: EXPERIMENTAL

Recombinant COVID-19 vaccine (Sf9 cells)

Intervention Type: BIOLOGICAL

This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified by antigen isolation and added with aluminum hydroxide adjuvant for the prevention of COVID-19.

Placebo Comparator

Three doses of placebo on Day 0, Day 21and Day 42.

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: OTHER

Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate) are consistent with the study vaccine and have been tested and qualified by National Institutes for Food and Drug Control.

Interventions

Recombinant COVID-19 vaccine (Sf9 cells)

This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified by antigen isolation and added with aluminum hydroxide adjuvant for the prevention of COVID-19.

Intervention Type: BIOLOGICAL

Placebo control

Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate) are consistent with the study vaccine and have been tested and qualified by National Institutes for Food and Drug Control.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18 years and older.
• Able and willing (in the investigator's opinion) to comply with all study requirements.
• Willing to allow the investigators to discuss the volunteer's medical history with their general practitioner/personal doctor and access all medical records which are relevant to study procedures.

Exclusion Criteria

• For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 90 days after completion of 3 doses vaccination, and have negative pregnancy tests before each dose vaccination. Note: Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status.
• Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (see glossary) and refrain from donating sperm for 90 days after receiving the study vaccination.
• Agreement to refrain from blood donation during the study.
• Provide a written informed consent form (ICF)

• Participation in any other COVID-19 prophylactic drug trials during the duration of the study.

Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible.

• Positive HIV antibody testing results.
• Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus during the duration of the study.

Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys

• Planned receipt of any licensed or investigational vaccine, other than the study intervention,within 14 days before and after study vaccination.
• Prior receipt of an investigational or licensed COVID-19 vaccine.
• Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the investigational products (IPs).
• History of allergic disease or reactions likely to be exacerbated by any component of Recombinant COVID-19 Vaccine (Sf9 cells).
• Any history of angioedema
• Pregnancy, lactation, or willingness/intention to become pregnant within 90 days after receiving study vaccine
• Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• History of serious psychiatric condition likely to affect participation in the study
• A bleeding disorder (e g factor deficiency coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following IM injections or venipuncture
• Suspected or known current alcohol or drug dependency
• Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease,liver disease, renal disease, an endocrine disorder, and neurological illness (mild/moderate well-controlled comorbidities are allowed)
• History of laboratory-confirmed COVID-19
• Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran, and edoxaban)
• Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study, or impair interpretation of the study data.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

WestVac Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Puskesmas Ciketingudik

Bekasi, Jiangsu, Indonesia

Permata Hospital

Bekasi, , Indonesia

Brawijaya University Hospital

Malang, , Indonesia

Universitas Muhammadiyah Malang Hospital

Malang, , Indonesia

Airlangga University Hospital

Surabaya, , Indonesia

Husada Utama Hospital

Surabaya, , Indonesia

Moi Teaching and Referral Hospital，Eldoret (MTRH)

Eldoret, , Kenya

KAVI-Institute of Clinical Research, University of Nairobi

Nairobi, , Kenya

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, , Mexico

Centro de Investigación Clínica y medicina traslacional (CIMeT)

Guadalajara, , Mexico

Hospital General Dr. Manuel Gea González

Mexico City, , Mexico

Invesclinic MX

Mexico City, , Mexico

Clínica de Enfermedades Crónicas y de Procedimientos Especiales

Morelia, , Mexico

SMIQ，S de R.L. de C.V.

Querétaro, , Mexico

FS Scientia Pharma SA de CV

San Luis Potosí City, , Mexico

Bharatpur Hospital

Kathmandu, , Nepal

Perpetual Succour Hospital - The Research Institute

Cebu City, , Philippines

St Luke Medical Centre - BGC

City of Taguig, , Philippines

De La Salle Medical and Health Sciences Institute

Dasmariñas, , Philippines

The Medical City - Iloilo

Iloilo City, , Philippines

West Visayas State University Medical Center

Iloilo City, , Philippines

Tropical Disease Foundation

Makati City, , Philippines

Makati Medical Center

Makati City, , Philippines

Quirino Memorial Medical Center

Quezon City, , Philippines

Countries

Indonesia; Kenya; Mexico; Nepal; Philippines

Other Identifiers

JSVCT109

Identifier Type: -

Identifier Source: org_study_id

NCT04887207

Identifier Type: -

Identifier Source: nct_alias