COVID-19
Conditions
Brief summary
This is a multicenter designed Phase III clinical trial. About 10000 participants plan to be enrolled.The objectives of this study are to evaluate the efficacy, safety and immunogenicity of the recombinant two-component COVID-19 vaccine (CHO cell) in adults
Detailed description
This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical trial. The objectives are to evaluate the efficacy, safety, and immunogenicity of ReCOV in adults aged 18 years and older who have not received any COVID-19 vaccination, and have no history of known COVID-19 in previous 6 months. Three-dose intramuscular (IM) vaccination schedule (21 days interval) will be applied. About 10000 participants (about 15% participants ≥ 60 years old) with SARS-CoV-2 antibody (IgM and IgG) negative at baseline, will be randomized in a ratio of 1:1 to receive ReCOV (20 μg) or placebo on Day 0, Day 21, and Day 42, respectively. Participants will be stratified by age (18-59 years, ≥ 60 years) and study sites (if applicable). For efficacy visits, study staff will contact participants on a weekly basis to remind reporting any signs or symptoms of COVID-19. If participants report any signs or symptoms that may be related to COVID-19, they will be required to immediately conduct an unscheduled visit under the instruction by site staff for COVID-19 related assessment and receiving treatment as deemed appropriate. For reactogenicity and safety visits, all vaccinated participants will be observed for 30 minutes after each dose vaccination at study site for solicited or unsolicited AEs, and will be given subject diary to record solicited AEs within 7 days after each vaccination, and unsolicited AEs from the 1st vaccination to 28 days after the 3rd vaccination. Approximately 600 participants will be included in the immunogenicity subgroup. Except for the efficacy and safety follow-up visits described above, this subgroup will be collected blood sample on Day 0 (pre-vaccination) and 14 days (+3 days), 90 days (±15 days) and 6 months (±15 days) after the 3rd dose.
Interventions
Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter
BIOLOGICALPlacebo
Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter
Sponsors
Jiangsu Rec-Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18 years and older. 2. Able and willing to comply with all study requirements. 3. Willing to allow investigators to discuss the medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures. 4. Healthy adults, or adults with stable medical condition who have a pre-existing medical condition that does not meet any
Exclusion criteria
. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. 5. For females of childbearing potential only, willing to practice continuous effective contraception until 90 days after the final dose vaccination, and have negative pregnancy tests before each dose vaccination. * Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal. A follicle-stimulating hormone (FSH) level and the amenorrhea duration (e.g. amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause) may be measured at the discretion of investigator to confirm postmenopausal status. * The effective contraceptive methods include sexual abstinence or adequate contraceptive measures such as intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, condoms (male), diaphragm, and cervical cap, etc. 6. Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (as described above) and refrain from donating sperm until 90 days after receiving the final dose vaccination. 7. Agreement to refrain from blood donation during the study. 8. Provide written informed consent form (ICF) prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of ReCOV in preventing Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed symptomatic COVID-19 in adults | > 14 days after 3 doses vaccination. | RT-PCR confirmed symptomatic COVID-19 cases (regardless of severity) that occurred \> 14 days after 3 doses vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety and reactogenicity | within 7 days after each vaccination | The occurrence of solicited local and systemic adverse events (AEs) within 7 days after each vaccination. |
| To evaluate the efficacy of ReCOV in preventing RT-PCR confirmed symptomatic COVID-19 with various severity in adults | > 14 days after 3 doses vaccination. | RT-PCR confirmed moderate, severe, critical COVID -19, or death that occurred \> 14 days after 3 doses vaccination |
| To compare the immunogenicity of ReCOV between Asian and Non-Asian in the immunogenicity subgroup | at 14 days,3 months and 6 months after 3 doses vaccination | The SCR and GMT of neutralizing antibody against prototype at 14 days,3 months and 6 months after 3 doses vaccination. |
| Genotyping of SARS-CoV-2 virus nucleic acid sequence of COVID-19 cases to evaluate the possible viral mutations | >14 days after 3 doses vaccination | SARS-CoV-2 virus nucleic acid sequence of RT-PCR confirmed symptomatic COVID-19 cases that occurred \>14 days after 3 doses vaccination derived from isolates or direct nasopharyngeal (NP) (preferred)/ oropharyngeal (OP) swab, or respiratory samples (including saliva samples, or bronchoalveolar lavage fluid, if applicable). |
| To evaluate the immunogenicity of ReCOV | at 14 days, 3 months and 6 months after 3 doses vaccination | The seroconversion rate (SCR), geometric mean titer (GMT) and geometric mean increase (GMI) of neutralizing antibody against prototype and epidemic strain at 14 days, 3 months and 6 months after 3 doses vaccination. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory : | > 14 days after the first dose vaccination | To evaluate the efficacy of ReCOV after the first dose vaccination in preventing RT-PCR confirmed symptomatic COVID-19 in adults aged 18 years and older. |
Countries
Nepal, Russia
Outcome results
None listed