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

ABSTRACT

ConditionCOVID-19

InterventionBiological Recombinant COVID-19 vaccine (Sf9 cells);Other Placebo control

Primary outcome:Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring, regardless of severity.;The incidence of serious adverse events(SAEs).;The incidence of adverse event of special interests(AESIs).;The incidence of medically attended adverse events(MAAEs).;The incidence of solicited adverse events(AEs).;The incidence of unsolicited adverse events(AEs) .

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.