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A Global, Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Protective Efficacy, Safety and Immunogenicity of SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine in Population Aged 18 Years and Older

PHRR220211-004339

ARC0V-005

2021-CT0632

A Global, Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Protective Efficacy, Safety and Immunogenicity of SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine in Population Aged 18 Years and Older

Primary Objectives:
Protective Efficacy:
To evaluate the protective efficacy of the SARS-CoV-2 mRNA vaccine in the prevention of COVID-19 (refer to Appendix 1) starting from at least 14 days (≥D42) after the two-dose immunization (with an interval of 28 days) in subjects aged 18 years and older.
Safety:
To evaluate the safety and reactogenicity of the SARS-CoV-2 mRNA vaccine after the two-dose immunization (with an interval of 28 days) in subjects aged 18 years and older.
Secondary Objectives:
Protective Efficacy:
1. To observe the protective efficacy of the SARS-CoV-2 mRNA vaccine in the prevention of severe and critical COVID-19 (refer to Appendix 1) starting from at least 14 days (≥D42) after the two-dose immunization (with an interval of 28 days) in subjects aged 18 years and older;
2. To observe the protective efficacy of the SARS-CoV-2 mRNA vaccine in the prevention of COVID-19 leading to death (refer to Appendix 1) starting from at least 14 days (≥D42) after the two-dose immunization (with an interval of 28 days) in subjects aged 18 years and older;
3. To observe the protective efficacy of the SARS-CoV-2 mRNA vaccine in the prevention of COVID-19 (refer to Appendix 1) starting from at least 14 days (≥D14) after the first vaccination in subjects aged 18 years and older.
Safety:
1. To observe the serious adverse events (SAEs) and adverse events of special interest (AESIs) from the first vaccination through 12 months after two-dose immunization in a population aged 18 years and older.
Exploratory objectives:
1. To observe the seroconversion rate, geometric mean titer (GMT) and geometric mean increase (GMI) of SARS-CoV-2 S-RBD specific IgG antibody at day 14, day 28, month 3, month 6 and month 12 after two-dose immunization among subjects in the immunogenicity subgroup;
2. To observe the seroconversion rate, geometric mean titer (GMT) and geometric mean increase (GMI) of anti-SARS-CoV-2 pseudovirus neutralizing antibody at day 14, day 28, month 3, month 6 and month 12 after two-dose immunization among subjects in the immunogenicity subgroup;
3. To observe the seroconversion rate, geometric mean titer (GMT) and geometric mean increase (GMI) of anti-SARS-CoV-2 euvirus neutralizing antibody at day 14, day 28, month 3, month 6 and month 12 after two-dose immunization among subjects in the immunogenicity subgroup.

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Access to essential medical products, vaccines and technologies
Start Date Duration in Months Target Completion Date Actual Completion Date
2021-11-16 24 2023-11-16 2024-12-31

Ongoing

Institution Classification Region LTO #
Yuxi Walvax Biotechnology Co., Ltd. Private Business China
Institution Classification Region LTO #
Tigermed Services Philippines Inc. Private Business Philippines CDRR-NCR-CRO-100581
Institution Region
Yuxi Walvax Biotechnology Co., Ltd. China
Name E-Mail Institution and Institution Address
Bombarda, Camilo Jr, C camilo.bombarda@TigermedGrp.com Tigermed Services Philippines Inc.
Name E-Mail Institution and Institution Address
Chen Cong cong.chen@tigermedgrp.com Tigermed Group
Name Expertise Affiliation
Aiza Chrysan Blanco Estabillo IM-Pulmonologist Dagupan Doctor's Villaflor Memorial Hospital
Aretha Ann Liwag, MD IM- Endocrilonogist West Visasyas State University Medical Center
Dovie Lallaine Borra Ygpuarra Internal Medicine/Adult Diseases St Pauls Hospital Iloilo
Gretchen Ang Manuel Internal Medicine Adventist Hospital - Santiago City
Joseph M Tovera Medical Oncologist ACE Medical Center Palawan
Lenora C. Fernandez MD IM- Cardiologist Asian Hospital and Medical Center
Maria Cristina Alberto Pediatrics Health Index Multispecialty Clinic (Bacoor Cavite)
Maria Concepcion Marcelo Internal Medicine - Diabetes Cardinal Santos Medical Center
Mario Panaligan Infectious Disease St Luke Medical Center - Global City
Olivia Piores-Roderos, MD Internal Medicine Endocrinologist De La Salle Health Sciences Institute
Rod T. Castro IM Cardiology Tropical Disease Foundation, Inc.
Ronaldo Panganiban Jr., MD IM-Adult Pulmnologist Green City Medical Center
Project Location Institutional Ethics Review Board
Dagupan Doctor's Villaflor Memorial Hospital Medical Center Manila Ethics Review Board
West Visasyas State University Medical Center West Visayas State University Unified Biomedical Research Ethics Review Committee
St Pauls Hospital Iloilo St. Paul’s Hospital Iloilo – Institutional Ethics Review Board
Adventist Hospital - Santiago City St. Cabrini Medical Center – Asian Eye Institute Ethics Review Committee
ACE Medical Center Palawan St. Cabrini Medical Center – Asian Eye Institute Ethics Review Committee
Asian Hospital and Medical Center Asian Hospital and Medical Center Institutional Review Board
Health Index Multispecialty Clinic (Bacoor Cavite) St. Cabrini Medical Center – Asian Eye Institute Ethics Review Committee
Cardinal Santos Medical Center Cardinal Santos Medical Center Ethics Review Committee
St Luke Medical Center - Global City St. Luke's Medical Center Institutional Ethics Review Board
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee
Tropical Disease Foundation, Inc. Makati Medical Center Institutional Review Board
Green City Medical Center St. Cabrini Medical Center – Asian Eye Institute Ethics Review Committee

Prevention of COVID-19 caused by SARS-CoV-2.

Primary Objectives:
Protective Efficacy:
To evaluate the protective efficacy of the SARS-CoV-2 mRNA vaccine in the prevention of COVID-19 (refer to Appendix 1) starting from at least 14 days (≥D42) after the two-dose immunization (with an interval of 28 days) in subjects aged 18 years and older.
Safety:
To evaluate the safety and reactogenicity of the SARS-CoV-2 mRNA vaccine after the two-dose immunization (with an interval of 28 days) in subjects aged 18 years and older.

Objectives:
Protective Efficacy:
1. To observe the protective efficacy of the SARS-CoV-2 mRNA vaccine in the prevention of severe and critical COVID-19 (refer to Appendix 1) starting from at least 14 days (≥D42) after the two-dose immunization (with an interval of 28 days) in subjects aged 18 years and older;
2. To observe the protective efficacy of the SARS-CoV-2 mRNA vaccine in the prevention of COVID-19 leading to death (refer to Appendix 1) starting from at least 14 days (≥D42) after the two-dose immunization (with an interval of 28 days) in subjects aged 18 years and older;
3. To observe the protective efficacy of the SARS-CoV-2 mRNA vaccine in the prevention of COVID-19 (refer to Appendix 1) starting from at least 14 days (≥D14) after the first vaccination in subjects aged 18 years and older.
Safety:
1. To observe the serious adverse events (SAEs) and adverse events of special interest (AESIs) from the first vaccination through 12 months after two-dose immunization in a population aged 18 years and older

Recruiting

  • Indonesia
  • Mexico
  • Nepal
  • Philippines

Clinical Trial

ARC0V-005

2021-CT0632

2021-11-16

2021-07-01

8000

6300

Recruitment is still on going.

2021-12-29

Inclusion Criteria:

1. Adults aged 18 years and older, male and female;
2. Understanding the contents of the informed consent form and information of this clinical study, and be willing to and able to sign the informed consent form;
3. Be able to well communicate with the investigator, and to understand and comply with the requirements of this clinical study;
4. Being at risks of infection with or exposure to SARS-CoV-2 or COVID-19 due to factors such as regions, occupation, activities, environment etc.
5. For female subjects: having no childbearing potential or having used effective methods of contraception within 2 weeks prior to enrollment into this study, having a negative pregnancy test. No childbearing potential includes amenorrhea for at least 1 year or medical record documented surgical sterilization. Subjects voluntarily agree to continue using effective contraceptive methods until 3 months after the fourth dose. The effective contraceptive methods include sexual abstinence or adequate contraceptive methods such as intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, intrauterine device (IUD), condoms (male), diaphragm, and cervical cap, etc.;
6. Healthy subjects or subjects with mild underlying diseases [in a stable status that the disease does not worsen (requiring no hospitalization for treatment or no major adjustment of treatment regimens) for at least 3 months prior to enrollment into this study].

Exclusion Criteria:

1. Medical history of COVID-19 or prior use of any medications to prevent COVID-19 (e.g., history of vaccination against any SARS-CoV-2 vaccine, marketed or not marketed);
2. Positive results of SARS-CoV-2 etiological testing (RT-PCR Assay) (subjects with serological testing showing positive IgG antibody and/or IgM antibody can be enrolled);
3. Prior medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and other human coronavirus infections or diseases;
4. Fever (oral temperature≥37.5°C/ axillary temperature≥37.3°C) on the day of the first vaccination or within recent 72 hours;
5. Pregnant (e.g., positive pregnancy test) or breastfeeding women;
6. Plan of pregnancy or interruption of effective contraceptive methods within 3 months after the fourth vaccination in this study;
7. Personnel of the study institution or sponsor;
8. Prior history of allergic reaction or anaphylaxis to any vaccine or drug, e.g., hypersensitivity, urticaria, serious eczema, difficulty breathing, laryngeal edema, and angioedema etc.;

9. Have inoculated or planned to inoculate with any vaccines other than the vaccines used in this clinical study from 28 days prior to the first vaccination to 28 days after the fourth vaccination in this study (except “vaccines for emergency” such as tetanus vaccine or rabies vaccine);
10. Have participated in or planned to participate in clinical studies of other drugs from 28 days prior to the first vaccination to 12 months after the fourth vaccination in this study;
11. 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 intramuscular injection or venipuncture injury;
12. Known medical history or diagnosis confirming that subjects have diseases affecting immune system function, including cancer (except skin basal cell carcinoma), congenital or acquired immunodeficiency (e.g., infection with human immunodeficiency virus (HIV)), uncontrolled autoimmune disease;
13. Asplenia or functional asplenia;
14. Long-term use (continuous use ≥14 days) of immunosuppressants or other immunomodulators (e.g., glucocorticoids: prednisone or similar drugs) within 6 months prior to the first vaccination in this study, except for topical medications (e.g., ointments, eye drops, inhalants or nasal sprays). However, the topical medications should not exceed the recommended dose in the package insert or induce any signs of systemic exposure;
15. Having received immunoglobulins and/or blood products within 3 months prior to the first vaccination in this study;
16. Suspected or known alcohol dependency or drug abuse, which may affect safety evaluation or subject’s compliance;
17. Planning to permanently move from the local area before study completion or leave the local area for a long time during the period of study visits;
18. Other circumstances considered by the investigator as inappropriate to participate in the study.

Observational

Unspecified

Unspecified

Date Amendment Classification Reason
2022-01-26 Amendments related to the protocol Informed consent

Randomized

Double Blind

Randomized, double-blind, placebo-controlled, parallel-group study.

Parallel

This vaccine is indicated for the prevention of COVID-19 caused by SARS-CoV-2.

Phase III

Utilization Utilization Info
Publication

Not Applicable.

Oral Presentation

Not Applicable.

Drug Literature

Not Applicable.

Posters

Not Applicable.

Others

Not Applicable.

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