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

NCT04904471 | Completed Phase 3 DMC

• 1 other identifier: JSVCT109
• Study Type: interventional
• Target: 39,663
• Locations: 5 countries
• Sites: 24

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.

Conditions

COVID-19

Keywords

SARS-CoV-2 Vaccine; Recombinant Vaccine; Efficacy; Safety; Immunnogenicity

Outcome Measures

Primary Outcomes (6)

• Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring, regardless of severity.

  Virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ﹥ 28 days after completion of 3 doses vaccination, regardless of severity.

  28 days after completion of 3 doses vaccination.

• The incidence of serious adverse events(SAEs).

  Serious adverse events(SAEs) from Day 0 through 6 months after completion of 3 doses vaccination.

  Day 0 to 6 months after completion of 3 doses vaccination.

• The incidence of adverse event of special interests(AESIs).

  Adverse event of special interests(AESIs) from Day 0 through 6 months after completion of 3 doses vaccination.

  Day 0 to 6 months after completion of 3 doses vaccination.

• The incidence of medically attended adverse events(MAAEs).

  Medically attended adverse events(MAAEs) from Day 0 through 6 months after completion of 3 doses vaccination.

  Day 0 to 6 months after completion of 3 doses vaccination.

• The incidence of solicited adverse events(AEs).

  Solicited adverse events(AEs) within 7 days after each dose vaccination.

  0 to 7 days after each dose vaccination

• The incidence of unsolicited adverse events(AEs) .

  Unsolicited adverse events(AEs) within 21 days after the first dose and the second dose, and within 28 days after the third dose vaccination.

  0 to 21 days after the first dose and the second dose vaccination, and 0 to 28 days after the third dose vaccination

Secondary Outcomes (16)

• Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring , regardless of severity.

  14 days after completion of 3 doses vaccination.

• Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring.

  14 days after completion of 3 doses vaccination.

• Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring.

  28 days after completion of 3 doses vaccination

• Virologically confirmed (polymerase chain reaction(PCR) positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring.

  14 days after completion of 3 doses vaccination

• Virologically confirmed (polymerase chain reaction(PCR) positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring.

  28 days after completion of 3 doses vaccination

Other Outcomes (2)

• SARS-CoV-2 virus nucleic acid sequence of COVID-19 cases that occurred derived from isolates or direct NP/OP swab.

  28 days after completion of 3 doses vaccination

• Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring in different age groups, regardless of severity.

  28 days after completion of 3 doses vaccination

Study Arms (2)

Experimental

EXPERIMENTAL

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

Biological: Recombinant COVID-19 vaccine (Sf9 cells)

Placebo Comparator

PLACEBO COMPARATOR

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

Other: Placebo control

Interventions

Recombinant COVID-19 vaccine (Sf9 cells) 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.

Experimental

Placebo control 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.

Placebo Comparator

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• WestVac Biopharma Co., Ltd.: lead
• West China Hospital: collaborator

Study Sites (24)

Puskesmas Ciketingudik

Bekasi, Jiangsu, 210009, Indonesia

Location

Permata Hospital

Bekasi, Indonesia

Location

Brawijaya University Hospital

Malang, Indonesia

Location

Universitas Muhammadiyah Malang Hospital

Malang, Indonesia

Location

Airlangga University Hospital

Surabaya, Indonesia

Location

Husada Utama Hospital

Surabaya, Indonesia

Location

Moi Teaching and Referral Hospital，Eldoret (MTRH)

Eldoret, Kenya

Location

KAVI-Institute of Clinical Research, University of Nairobi

Nairobi, Kenya

Location

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, Mexico

Location

Centro de Investigación Clínica y medicina traslacional (CIMeT)

Guadalajara, Mexico

Location

Hospital General Dr. Manuel Gea González

Mexico City, Mexico

Location

Invesclinic MX

Mexico City, Mexico

Location

Clínica de Enfermedades Crónicas y de Procedimientos Especiales

Morelia, Mexico

Location

SMIQ，S de R.L. de C.V.

Querétaro, Mexico

Location

FS Scientia Pharma SA de CV

San Luis Potosí City, Mexico

Location

Bharatpur Hospital

Kathmandu, Nepal

Location

Perpetual Succour Hospital - The Research Institute

Cebu City, Philippines

Location

St Luke Medical Centre - BGC

City of Taguig, Philippines

Location

De La Salle Medical and Health Sciences Institute

Dasmariñas, Philippines

Location

The Medical City - Iloilo

Iloilo City, Philippines

Location

West Visayas State University Medical Center

Iloilo City, Philippines

Location

Tropical Disease Foundation

Makati City, 1230, Philippines

Location

Makati Medical Center

Makati City, Philippines

Location

Quirino Memorial Medical Center

Quezon City, 1109, Philippines

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: May 27, 2021
• Study Start: June 15, 2021
• Primary Completion: January 31, 2022
• Study Completion: November 1, 2023
• Last Updated: March 26, 2025

Record last verified: 2024-03

Locations

ME (7); NE (1); PH (8); ID (6); KE (2)