Approximately 28,000 subjects will be enrolled in this trial. Eligible subjects will bestratified by age (
Not Provided
Biological: SARS-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).
Biological: Placebo
0.9% sodium chloride solution, 0.5 mL/vial
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.
Exclusion Criteria:
Exclusion criteria for first dose vaccination
Subjects who meet any of the following exclusion criteria shall not be enrolled:
1. Individuals with a history of SARS-CoV-2 infection or use of any preventive products
for COVID-19 (e.g., a history of any SARS-CoV-2 vaccines that have or have not been
marketed);
2. Individuals with SARS-CoV-2 etiological testing (RT-PCR Assay) (individuals with
serological testing showing positive IgG and/or IgM antibodies may be enrolled);
3. Individuals with a previous history of severe acute respiratory syndrome (SARS),
middle east respiratory syndrome (MERS) and other human coronavirus infections or
diseases;
4. Individuals who have fever within 72 hours prior to Dose 1 in this trial (oral
temperature ≥38°C);
5. Pregnant (e.g., positive pregnancy test) or lactating females;
6. Individuals who have plan of pregnancy or interruption of effective contraceptive
methods within 3 months after the second cross-vaccination in this study;
7. Personnel of the study site or the sponsor;
8. Individuals with prior history of allergic reaction or anaphylaxis to any vaccine or
drug, e.g., hypersensitivity, urticaria, serious eczema, dyspnea, laryngeal edema,
and angioedema etc.;
9. Individuals who have been vaccinated with any vaccine other than the investigational
vaccine used in this clinical trial from 28 days prior to Dose 1 to 28 days after
Dose 2;
10. Individuals who have participated in or plan to participate in other drug clinical
trials form 28 days prior to Dose 1 to 12 months after Dose 4 (the second dose of
cross-vaccination) in this study;
11. Individuals who have hereditary hemorrhagic tendency or coagulation dysfunction
(e.g., cytokine defects, coagulation disorders or platelet disorder), or a history
of significant bleeding, or a history of injury caused by intramuscular injection or
venipuncture;
12. Individuals who are confirmed for diseases affecting immune system function,
including cancer (except skin basal cell carcinoma), congenital or acquired
immunodeficiency (e.g., infection with human immunodeficiency virus (HIV)), and
uncontrolled autoimmune disease, based on known history or diagnosis;
13. Individuals who have asplenia or functional asplenia;
14. Individuals with long-term use (continuous use ≥14 days) of immunosuppressants or
other immunomodulatory drugs (e.g., corticosteroids: prednisone or similar drugs)
within 6 months prior to Dose 1. Drugs for topical use (e.g., ointment, eye drops,
inhalants or nasal spray) are allowed in this study, and the topical medications
should not exceed the recommended dose in the labels for use or induce any signs of
systemic exposure;
15. Individuals who have received immunoglobulin and/or blood products within 3 months
prior to Dose 1;
16. Individuals who are suspected or known to have alcohol dependency problems or drug
abuse that may affect safety evaluation or subject's compliance;
17. Individuals who plan to permanently relocate from the local area before the
completion of the study or leave the local area for long periods during the study
visits;
18. Other circumstances considered by the investigator as inappropriate to participate
in the study.
Criteria for Postponement of the Subsequent Doses:
If the subjects have any of the followings prior to the subsequent doses, vaccination
will be postponed. During the same immunization schedule, the second dose of vaccine will
be administered at the 28th day after the first vaccination, with a time window of +5
days:
1. Fever within 72 hours prior to the subsequent doses (oral temperature ≥38°C,
probability of SARS-CoV-2 infection shall be excluded);
2. In case of acute diseases prior to the subsequent doses, the investigator shall
exclude the probability of SARS-CoV-2 infection and evaluate the likelihood of
short-term recovery for the diseases;
Exclusion Criteria for the Subsequent Doses:
If the subject has any of the followings prior to the subsequent doses, the vaccination
shall be terminated for the subject while other study procedures could be continued at
the discretion of the investigators:
1. Female subjects of childbearing potential who have positive pregnancy test results;
2. Subjects who have a serious allergic reaction or serious adverse event causally
related to vaccination after previous vaccination;
3. Other circumstances considered by the investigator as inappropriate to receive the
subsequent doses of the vaccine.
Criteria for Withdrawal from the Study
1. Subjects experience disability, life-threatening adverse events or serious adverse
events and have to prematurely withdraw from this study due to treatment or other
reasons.
2. Subjects are placed at safety risks by their health conditions which prevent them
from continuing to participate in this study.
3. Female subjects become pregnant during the study (if at least one dose has been
administered, the subject is not required to withdraw from this study but should not
receive the subsequent doses. Moreover, subsequent observation and follow-up visits
should be continued);
4. Subjects actively request to withdraw from the study;
5. Subjects are considered unsuitable for continuing to participate in this study at
the discretion of the investigator.
Persahabatan Hospital
Jakarta, Indonesia
Puskesmas Duren Sawit
Jakarta, Indonesia
Puskesmas Kalideres
Jakarta, Indonesia
Puskesmas Kebayoran Lama
Jakarta, Indonesia
Puskesmas Pulogadung
Jakarta, Indonesia
Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)
Acapulco, Mexico
Centro de Investigación y Avances Médicos Especializados (CIAME)
Cancun, Mexico
Centro de Especialidades Médicas Aplicadas
Mexico city, Mexico
Instituto Nacional de Pediatría (INP)
Mexico city, Mexico
Oaxaca site management organization (OSMO)
Oaxaca, Mexico
Asociación Mexicana para la investigación clínica, A.C. (AMIC)
Pachuca, Mexico
Oncológico Potosino
San Luis Potosi, Mexico
Shuyuan Yang
+86 18687832269
ynwsysy@walvax.com
Not Provided