A clinical trial of China-made recombinant SARS-CoV-2 vaccine (Sf9 cells)

JRCT ID: jRCT2051210057

Registered date:29/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of COVID-19
• Date of first enrollment: 27/08/2021
• Target sample size: 240
• Study type: Interventional
• Intervention(s): A series of 3 doses, 1.0 mL each, of either the test product or placebo will be administered to the upper arm of one side. The second and third doses will be given 22 and 43 days after the first dose.

Outcome(s)

• Primary Outcome: Incidence of adverse reactions (ARs) during the 7 days following the start of each dosing in each cohort

Secondary Outcome

1. Safety endpoints
1) Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs of special interest during the 7 days following the start of each dosing in each cohort
2) Incidence of specific local reactions (pain, induration, swelling, redness, pruritus, cellulitis, tenderness) and specific systemic reactions (nausea, fever, cough, arthralgia, diarrhea, inappetence, pharyngeal pain, headache, malaise/feeling of weakness, vomiting, myalgia, pruritus) during the 7 days following the start of each dosing in each cohort
3) Incidence of AEs, ARs, SAEs, and AEs of special interest during the 71 days following the start of first dosing (i.e., up to 28 days after last dose) in each cohort
4) Incidence of AEs, ARs, SAEs, and AEs of special interest during the 408 days following the start of first dosing in each cohort
5) Laboratory test values (blood chemistry, hematology, coagulation, routine urinalysis): Change from baseline (within 7 days before first dosing) to 8, 29, and 50 days after each dosing in each cohort

2. Immunogenicity endpoints
Humoral immunity
1) Geometric mean antibody titer (GMT), seroconversion rate (SCR), and geometric mean fold increase (GMI) for SARS-CoV-2 S-RBD specific antibodies (ELISA) at Days 1, 22, 43, 50, 71, 223, and 408 in each cohort
2) Geometric mean antibody titer (GMT), seroconversion rate (SCR), and geometric mean fold increase (GMI) for SARS-CoV-2 neutralizing antibodies (true virus or pseudovirus neutralization assay) at Days 1, 22, 43, 50, 71, 223, and 408 in each cohort

Cellular immunity
1) The Th1/Th2 ratio at Days 1, 50, and 71 in each cohort (evaluated only in 30 subjects in Group 3 of each cohort)

IgG subclass fractionation
1) IgG subclass fractionation at Days 1, 50, and 71 in each cohort (evaluated only in 30 subjects in Group 3 of each cohort)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Subjects aged between >18 and <85 years at the time of informed consent
2) Subjects who provided written informed consent. For underage subjects, written consent must be obtained from the subject and the subjects legally acceptable representative
3) Subjects who will be available for the study schedule and able to comply with subject requirements of the study and at the study center
4) Subjects who are HIV-negative at screening
5) Subjects with an axillary body temperature of <37.0 digrees on the day of enrollment
6) Subjects with negative real-time polymerase chain reaction (PCR) for SARS-CoV-2 in saliva at screening
7) Subjects with negative serum anti-SARS-CoV-2 antibodies (IgG and IgM) at screening
8) Subjects without clinically relevant abnormal findings on chest X-ray at screening
9) Subjects with a body mass index (BMI) of >18.5 to <30.0 kg/m^2 at screening
10) Subjects without clinically relevant abnormal findings on 12-lead electrocardiogram (ECG) at screening
11) Subjects with all laboratory test values at screening being within the reference ranges for the population or laboratory, or subjects with values outside the reference ranges judged by the investigator/sub-investigator to be clinically insignificant
12) Female subjects of childbearing potential, who have a negative serum or urine pregnancy test and agree to use an adequate method of contraception during the study period
13)Subjects judged by the investigator/sub-investigator to be appropriate for inclusion in the study on the basis of the medical history, physical findings, and laboratory data

Exclude criteria

1) Subjects who previously received a vaccine against SARS-CoV-2
2) Subjects with close contact with a COVID-19 patient within 30 days prior to immunization of the investigational product (according to the definition of close contacts by the National Institute of Infectious Diseases
3) Subjects with a personal or family history of seizures, epilepsy, encephalopathy, or psychiatric disease
4) Subjects allergic to any of the ingredients of the test product or placebo
5) Subjects with a history of serious allergic reactions to vaccines
6) Subjects with any acute febrile disease or infectious disease
7) Subjects with a history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) or COVID-19
8) Subjects with a history of serious cardiovascular, respiratory, hematological, digestive, endocrine, neuropsychiatric, hepatic, or renal disease
9) Subjects with hereditary or acquired vascular/neurogenic edema
10) Subjects who had urticaria within 1 year prior to immunization of the investigational product
11) Subjects with asplenism, post-splenectomy or functional asplenism
12) Subjects with thrombocytopenia or any other coagulation disorder (possible contraindication to intramuscular injection)
13) Subjects with vasovagal reactions to needle insertion
14) Subjects who received immunosuppressive therapy, antiallergic therapy, cytotoxic therapy, or oral or inhaled corticosteroids (but not nasal corticosteroid sprays or topical corticosteroids) within 6 months prior to immunization of the investigational product
15) Subjects who received any blood product within 4 months prior to immunization of the investigational product
16) Subjects who participated in any other clinical trial or received any other study drug within 1 month prior to immunization of the investigational product in this study
17) Subjects who received an attenuated vaccine within 1 month prior to immunization of the investigational product
18) Subjects who received a subunit vaccine or inactivated vaccine within 14 days prior to immunization of the investigational product
19) Subjects receiving anti-tuberculosis therapy
20) Females with a positive pregnancy test. Females who are pregnant or breastfeeding or who plan to become pregnant within 6 months after immunization of the investigational product
21) Subjects judged by the investigator or sub-investigator to be inappropriate for participation in this study

Related Information

• Primary Sponsor: Fujita Yasuyuki