COVID-19
Conditions
Keywords
SARS-CoV-2 Vaccine, Recombinant Vaccine, Efficacy, Safety, Immunnogenicity
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.
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.
Interventions
BIOLOGICALRecombinant 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.
OTHERPlacebo 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.
Sponsors
West China Hospital
WestVac Biopharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of unsolicited adverse events(AEs) . | 0 to 21 days after the first dose and the second dose vaccination, and 0 to 28 days after the third dose vaccination | Unsolicited adverse events(AEs) within 21 days after the first dose and the second dose, and within 28 days after the third dose vaccination. |
| The incidence of solicited adverse events(AEs). | 0 to 7 days after each dose vaccination | Solicited adverse events(AEs) within 7 days after each dose vaccination. |
| Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring, regardless of severity. | 28 days after completion of 3 doses vaccination. | Virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ﹥ 28 days after completion of 3 doses vaccination, regardless of severity. |
| The incidence of serious adverse events(SAEs). | Day 0 to 6 months after completion of 3 doses vaccination. | Serious adverse events(SAEs) from Day 0 through 6 months after completion of 3 doses vaccination. |
| The incidence of adverse event of special interests(AESIs). | Day 0 to 6 months after completion of 3 doses vaccination. | Adverse event of special interests(AESIs) from Day 0 through 6 months after completion of 3 doses vaccination. |
| The incidence of medically attended adverse events(MAAEs). | Day 0 to 6 months after completion of 3 doses vaccination. | Medically attended adverse events(MAAEs) from Day 0 through 6 months after completion of 3 doses vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of serious adverse events(SAEs) in all participants. | Day 0 to 12 months after completion of 3 doses vaccination | Serious adverse events(SAEs) from Day 0 through 12 months after completion of 3 doses vaccination in all participants. |
| The incidence of adverse event of special interests(AESIs) in all participants. | Day 0 through 12 months after completion of 3 doses vaccination | Adverse event of special interests(AESIs) from Day 0 through 12 months after completion of 3 doses vaccination in all participants. |
| The geometric mean increase(GMI) of specific antibody. | Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination | 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). |
| The geometric mean titer(GMT) of specific antibody. | Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination | 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). |
| The seroconversion rate of live-virus neutralizing antibody. | Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination | The seroconversion rate of live-virus neutralizing antibody on 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. | 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 on 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. | 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 on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination. |
| The seroconversion rate of specific antibody. | Day 28, month 3, month 6, and month 12 after completion of 3 doses vaccination | 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). |
| The incidence of medically attended adverse events(MAAEs) in all participants. | Day 0 through 12 months after completion of 3 doses vaccination | Medically attended adverse events(MAAEs) from Day 0 through 12 months after completion of 3 doses vaccination in all participants. |
| Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring , regardless of severity. | 14 days after completion of 3 doses vaccination. | Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring ﹥14 days after completion of 3 doses vaccination, regardless of severity. |
| 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 ﹥ 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. | 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 ﹥ 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. | 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 ﹥ 14 days after completion of 3 doses vaccination, regardless of symptomatology or severity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
Countries
Indonesia, Kenya, Mexico, Nepal, Philippines
Outcome results
None listed