Official Title
A Global Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells), for the Prevention of COVID-19 in Adults Aged 18 Years and Older
Brief Summary

This Phase III study is a global multicenter, randomized, double-blind,placebo controlledclinical trial to evaluate the efficacy, safety, and immunogenicity of therecombinantCOVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older who do nothave a known history of SARS-CoV-2 infection but whose locations or circumstances putthem 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.

Active, not recruiting
COVID-19

Biological: 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.

Other: 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.

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.

- Healthy adults, or stable-healthy adults who may have a pre-existing medical
condition that does not meet any exclusion criteria. A stable medical condition is
defined as a disease not requiring significant change in therapy or hospitalization
for worsening disease during the 3 months before enrollment.

- 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)

Exclusion Criteria:

Exclusion criteria for the first dose

- 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).

- Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV
status;asplenia; recurrent severe infections and chronic use (more than 14 days) of
immunosuppressant medication within the past 6 months. Topical steroids or
short-term (course lasting ≤14 days) oral steroids are not exclusion criteria.

- 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.

Exclusion criteria for the second/third dose In this trial, the second/third dose
vaccination may be terminated in some cases. These include systemic allergic reactions,
severe hypersensitivity reactions, or intolerable grade 3 or higher adverse reactions
after the previous vaccination/placebo. If these reactions occur, the participants should
not continue to receive the second/third vaccination.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Indonesia
Kenya
Mexico
Nepal
Philippines
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

Hospital General Dr. Manuel Gea González
Ciudad de México, Mexico

Invesclinic MX
Ciudad de México, Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, Mexico

Centro de Investigación Clínica y medicina traslacional (CIMeT)
Guadalajara, Mexico

Clínica de Enfermedades Crónicas y de Procedimientos Especiales
Morelia, Mexico

SMIQ,S de R.L. de C.V.
Queretaro, Mexico

FS Scientia Pharma SA de CV
San Luis Potosí, Mexico

Bharatpur Hospital
Kathmandu, Nepal

Perpetual Succour Hospital - The Research Institute
Cebu City, Philippines

De La Salle Medical and Health Sciences Institute
Dasmarinas, 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

St Luke Medical Centre - BGC
Taguig, Philippines

Not Provided

West China Hospital
NCT Number
Keywords
SARS-CoV-2 Vaccine
Recombinant vaccine
Efficacy
safety
Immunnogenicity
MeSH Terms
COVID-19