COVID-19, SARS-CoV-2
Conditions
Keywords
SARS-CoV-2 mRNA vaccine, Efficacy, Safety, Immunogenicity
Brief summary
Approximately 28,000 subjects will be enrolled in this trial. Eligible subjects will be stratified by age (\<60 years of age and ≥60 years of age, the proportion of elderly people ≥60 years old is planned to be ≥25%) and randomly assigned into the study group and the control group at a ratio of 1:1 (14,000 in each group) to be intramuscularly administered with the investigational vaccine or placebo in a 2-dose regimen at an interval of 28 days. The experimental vaccines will be cross-vaccinated after available data of the investigational vaccine show that expected efficacy and good safety have been achieved (i.e., subjects in the study group will be vaccinated with placebo and those in the control group will be vaccinated with the investigational vaccine in the same schedule as stated above ). After the completion of the second dose for crossover vaccination, subjects will be followed up for 12 months for safety observation. An immunogenicity subgroup (n≥3000) and a reactogenicity subgroup (n≥6000) will also be included in this trial to evaluate the humoral immunity induced by the investigational vaccine and the solicited adverse events observed within 7 days post immunization. All enrolled subjects will be followed up for the evaluation of protective efficacy as well, which will be primarily characterized by the incidence rate (person-year) of COVID-19 cases collected from 14 days after complete series. Adverse events will be collected over 0-28 days after each vaccination and serious adverse events will be collected from Dose 1 through 12 months post complete series.
Interventions
BIOLOGICALSARS-CoV-2 mRNA Vaccine
The SARS-CoV-2 mRNA Vaccine is formulated by encapsulating the mRNA, which encodes the receptor-binding domain (RBD) of spike glycoprotein (S protein) of SARS-CoV-2 and is transcribed in-vitro by the corresponding DNA template, in lipid nanoparticles (LNPs). This vaccine is presented as a white to off-white dispersion for injection. Active substances: mRNA encoding the RBD of the S protein of SARS-CoV-2. The vaccine is supplied in single-dose pre-filled syringe with 0.5 mL dispersion for intramuscular injection. Each dose (0.5 mL) of the vaccine contains: 15 μg of mRNA encoding the RBD of the spike glycoprotein (S protein) of SARS-CoV-2, 0.339 mg of total lipids (including lipid 9001, cholesterol, DSPC, DMG-PEG2000).
BIOLOGICALPlacebo
0.9% sodium chloride solution, 0.5 mL/vial
Sponsors
Abogen Biosciences Co. Ltd.
Yuxi Walvax Biotechnology Co., Ltd.
Walvax Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects included in this trial must meet all of the following inclusion criteria: 1. Adults aged 18 and above (both males and females are required); 2. Individuals who are able to understand the contents listed in the informed consent form and the procedure of this clinical trial; are able to sign the informed consent form voluntarily; 3. Individuals who are able to communicate well with the investigator and has the ability to understand and comply with the requirements of the clinical trial; 4. Individuals who are at risk of SARS-CoV-2 infection or are exposed to COVID-19 due to regional, occupational, activity and environmental factors; 5. For female participants of childbearing potential, effective contraception should be used within 2 weeks prior to participation in this study and the pregnancy test results is required to be negative (those with amenorrhea of at least 1 year or surgical sterilization verified by medical records could be exempted from the pregnancy test). Participants should voluntarily agree to continue using at least one effective methods of contraception for 12 months after complete series (effective methods include oral contraceptives, injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.). 6. Healthy individuals with verified medical history: individuals who are in a stable condition and whose current diseases will not worsen for at least 3 months prior to enrollment to this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases | From 14 days after complete series | The incidence rate (person-year) of COVID-19 cases collected from 14 days after complete series in subjects aged 18 years and above. |
| Primary safety endpoint as measured by the incidence rates of adverse events | Within 28 days post each vaccination | Incidence rates of adverse events observed for all subjects within 28 days post each vaccination; |
| Primary safety endpoint as measured by the incidence rates of serious adverse events | At 7 days post each vaccination | Incidence rates of solicited adverse events observed for subjects included in the reactogenicity subgroup within 30 minutes and at 7 days post each vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy endpoint as measured by the incidence rate (person-year) of severe and critical COVID-19 cases | From 14 days after complete series | The incidence rate (person-year) of severe and critical COVID-19 cases collected from 14 days after complete series in subjects aged 18 years and above; |
| Secondary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases resulting in deaths | From 14 days after complete series | The incidence rate (person-year) of COVID-19 cases resulting in deaths collected from 14 days after complete series in subjects aged 18 years and above; |
| Secondary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases post 1 dose of vaccination | From 14 days after Dose 1 | The incidence rate (person-year) of COVID-19 cases collected from 14 days collected after Dose 1 in subjects aged 18 years and above who fail to be administered with Dose 2 for personal reasons. |
| Secondary safety endpoint as measured by the incidence rate of serious adverse events | From Dose 1 through 12 months after complete series | Incidence rates of serious adverse events observed for all subjects from Dose 1 through 12 months after complete series. |
Countries
Indonesia, Mexico
Contacts
Primary ContactShuyuan Yang
Outcome results
None listed