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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Three doses of recombinant SARS-CoV-2 vaccine (Sf9 Cell) on Day 0, Day 21and Day 42. |
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| Placebo Comparator | Placebo Comparator | Three doses of placebo on Day 0, Day 21and Day 42. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring , regardless of severity. | Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring ﹥14 days after completion of 3 doses vaccination, regardless of severity. | 14 days after completion of 3 doses vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 virus nucleic acid sequence of COVID-19 cases that occurred derived from isolates or direct NP/OP swab. | SARS-CoV-2 virus nucleic acid sequence of COVID-19 cases that occurred > 28 days after completion of 3 doses vaccination derived from isolates or direct NP/OP swab. | 28 days after completion of 3 doses vaccination |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for the first dose
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.
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
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puskesmas Ciketingudik | Bekasi | Jiangsu | 210009 | Indonesia | ||
| Permata Hospital |
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| 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. |
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| Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 28 days after completion of 3 doses vaccination |
| Serologically confirmed SARS-CoV-2 infection or virologically confirmed (polymerase chain reaction(PCR) positive) COVID-19 cases first occurring, regardless of symptomatology or severity. | Serologically confirmed SARS-CoV-2 infection or virologically confirmed (polymerase chain reaction(PCR) positive) COVID-19 cases first occurring ﹥ 14 days after completion of 3 doses vaccination, regardless of symptomatology or severity. | 14 days after completion of 3 doses vaccination |
| Serologically confirmed SARS-CoV-2 infection or virologically confirmed (polymerase chain reaction(PCR) positive) COVID-19 cases first occurring, regardless of symptomatology or severity. | Serologically confirmed SARS-CoV-2 infection or virologically confirmed (polymerase chain reaction(PCR) positive) COVID-19 cases first occurring ﹥ 28 days after completion of 3 doses vaccination, regardless of symptomatology or severity. | 28 days after completion of 3 doses vaccination |
| The incidence of serious adverse events(SAEs) in all participants. | Serious adverse events(SAEs) from Day 0 through 12 months after completion of 3 doses vaccination in all participants. | Day 0 to 12 months after completion of 3 doses vaccination |
| The incidence of medically attended adverse events(MAAEs) in all participants. | Medically attended adverse events(MAAEs) from Day 0 through 12 months after completion of 3 doses vaccination in all participants. | Day 0 through 12 months after completion of 3 doses vaccination |
| The incidence of adverse event of special interests(AESIs) in all participants. | Adverse event of special interests(AESIs) from Day 0 through 12 months after completion of 3 doses vaccination in all participants. | Day 0 through 12 months after completion of 3 doses vaccination |
| The geometric mean increase(GMI) of specific antibody. | The geometric mean increase(GMI) of spike protein (S) receptor binding domain RBD region(S-RBD) IgG antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination, measured by enzyme-linked immunosorbent assays(ELISA). | Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination |
| The seroconversion rate of specific antibody. | The seroconversion rate of spike protein (S) receptor binding domain RBD region(S-RBD) IgG antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination, measured by enzyme-linked immunosorbent assays(ELISA). | Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination |
| The geometric mean titer(GMT) of specific antibody. | The geometric mean titer(GMT) of spike protein (S) receptor binding domain RBD region(S-RBD) IgG antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination, measured by enzyme-linked immunosorbent assays(ELISA). | Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination |
| The seroconversion rate of live-virus neutralizing antibody. | The seroconversion rate of live-virus neutralizing antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination. | Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination |
| The geometric mean titer(GMT) of live-virus neutralizing antibody. | The geometric mean titer(GMT) of live-virus neutralizing antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination. | Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination |
| The geometric mean increase(GMI) of live-virus neutralizing antibody. | The geometric mean increase(GMI) of live-virus neutralizing antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination. | Day 28, month 3, month 6, and month 12 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. |
Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring ﹥28 days after completion of 3 doses vaccination in different age groups (18-59 group and ≥60 groups), regardless of severity. |
| 28 days after completion of 3 doses vaccination |
| 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 | 1230 | Philippines |
| Makati Medical Center | Makati City | Philippines |
| Quirino Memorial Medical Center | Quezon City | 1109 | Philippines |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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