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7/22/2021 A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against COVID-19 in Population
ulation Aged 18 Years and Above - Full Text View - ClinicalTr…

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Trial record 4 of 403 for:

efficacy of mrna
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A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against
COVID-19 in Population Aged 18 Years and Above
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study
does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical
studies and talk to your health care provider before participating.
Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04847102
https://clinicaltrials.gov/ct2/show/NCT04847102?term=efficacy+of+mrna&draw=2&rank=4 1/11
7/22/2021 A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against COVID-19 in Population Aged 18 Years and Above - Full Text View - ClinicalTr…
Recruitment Status  : Not yet recruiting

First Posted  : April 15, 2021
Last Update Posted  : May 17, 2021
See Contacts and Locations
Sponsor:
Walvax Biotechnology Co., Ltd.
Collaborators:
Abogen Biosciences Co. Ltd.
Yuxi Walvax Biotechnology Co., Ltd.
Information provided by (Responsible Party):

Study Details Tabular View No Results Posted Disclaimer How to Read a Study Record
Study Description Go to
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.
Condition or disease  Intervention/treatment  Phase 
COVID-19 Biological: SARS-CoV-2 mRNA Vaccine Phase 3
SARS-CoV-2 Biological: Placebo
Study Design Go to
Study Type  : Interventional

(Clinical Trial)
Estimated
Enrollment  : 28000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Global, Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to
Evaluate the Protective Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Messenger
Ribonucleic Acid (mRNA) Vaccine Candidate in Population Aged 18 Years and Above
Estimated Study Start Date  : May 28, 2021
Estimated Primary Completion Date  : October 30, 2021
Estimated Study Completion Date  : May 30, 2023
Resource links provided by the National Library of Medicine
Drug Information available for:

Ribonucleic acid
U.S. FDA Resources
Arms and Interventions Go to
Arm  Intervention/treatment 
Experimental: Study group 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
Arm  Intervention/treatment 
Placebo Comparator: Control group 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
Outcome Measures Go to
Primary Outcome Measures  :
1. Primary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases [ Time Frame: 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.
2. Primary safety endpoint as measured by the incidence rates of adverse events [ Time Frame: Within 28 days post each vaccination ]
Incidence rates of adverse events observed for all subjects within 28 days post each vaccination;
3. Primary safety endpoint as measured by the incidence rates of serious adverse events [ Time Frame: 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 Outcome Measures  :
1. Secondary efficacy endpoint as measured by the incidence rate (person-year) of severe and critical COVID-19 cases
[ Time Frame: 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;
2. Secondary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases resulting in deaths
[ Time Frame: 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;
3. Secondary efficacy endpoint as measured by the incidence rate (person-year) of COVID-19 cases post 1 dose of vaccination
[ Time Frame: 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.
4. Secondary safety endpoint as measured by the incidence rate of serious adverse events [ Time Frame: 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.
Eligibility Criteria Go to
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members
or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the
study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria
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.
Contacts and Locations Go to
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact
information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847102
Contacts
Contact: Shuyuan Yang +86 18687832269 ynwsysy@walvax.com
Sponsors and Collaborators
Abogen Biosciences Co. Ltd.
Yuxi Walvax Biotechnology Co., Ltd.
More Information Go to
Responsible Party: Walvax Biotechnology Co., Ltd.

ClinicalTrials.gov Identifier: NCT04847102
History of Changes
Other Study ID Numbers: ARCoV-005
First Posted: April 15, 2021

Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Walvax Biotechnology Co., Ltd.:

SARS-CoV-2 mRNA vaccine
Efficacy
Safety
Immunogenicity

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7/22/2021 A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against COVID-19 in Population

ulation Aged 18 Years and Above - Full Text View - ClinicalTr…

Trial record 4 of 403 for:

Previous Study | Return to List |

Recruitment Status  : Not yet recruiting

See Contacts and Locations

Information provided by (Responsible Party):

Study Description Go to

Condition or disease  Intervention/treatment  Phase 

COVID-19 Biological: SARS-CoV-2 mRNA Vaccine Phase 3

SARS-CoV-2 Biological: Placebo

Study Design Go to

Study Type  : Interventional

Resource links provided by the National Library of Medicine

Drug Information available for:

U.S. FDA Resources

Arms and Interventions Go to

Experimental: Study group Biological: SARS-CoV-2 mRNA Vaccine

Active substances: mRNA encoding the RBD of the S protein of

The vaccine is supplied in single-dose pre-filled syringe with 0.5

15 μg of mRNA encoding the RBD of the spike glycoprotein (S

Placebo Comparator: Control group Biological: SARS-CoV-2 mRNA Vaccine

Active substances: mRNA encoding the RBD of the S protein of

The vaccine is supplied in single-dose pre-filled syringe with 0.5

15 μg of mRNA encoding the RBD of the spike glycoprotein (S

Outcome Measures Go to

Primary Outcome Measures  :

Secondary Outcome Measures  :

Eligibility Criteria Go to

Information from the National Library of Medicine

Exclusion criteria for first dose vaccination

5. Pregnant (e.g., positive pregnancy test) or lactating females;

7. Personnel of the study site or the sponsor;

13. Individuals who have asplenia or functional asplenia;

Criteria for Postponement of the Subsequent Doses:

Exclusion Criteria for the Subsequent Doses:

Criteria for Withdrawal from the Study

Contacts and Locations Go to

Information from the National Library of Medicine

Contact: Shuyuan Yang +86 18687832269 ynwsysy@walvax.com

Sponsors and Collaborators

Walvax Biotechnology Co., Ltd.

Abogen Biosciences Co. Ltd.

Yuxi Walvax Biotechnology Co., Ltd.

More Information Go to

Responsible Party: Walvax Biotechnology Co., Ltd.

First Posted: April 15, 2021

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Walvax Biotechnology Co., Ltd.:

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