ARCoV-005

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
1. RSUP Persahabatan (1101) 2. Puskesmas Kecamatan (PKC) Pulogadung (1103) 3. PKC Duren Sawit (1105) 4. PKC Kalideres (1107) 5. PKC Kebayoran Lama (1108) 6. RS Paru Dr.M.Goenawan Partowidigdo Cisarua, Bogor (1109) 7. RSUD Leuwiliang, Bogor (1110) 8. RSUD Ciawi, Bogor (1111) 9. RS Achmad Mochtar, Bukit Tinggi (1112) 10. RSUD dr.Rasidin, Padang (1113) 11. Puskesmas Mauk, Tangerang (1114)
No Registry
INA-MNL47N9
Tanggal Input Registry : 28-03-2022

14-10-2021
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 twodose 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.
 
ARCoV-005
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
Interventional
Vaksin Aktif ARCoV : Placebo/ Normal Saline dengan perbandingan 1:1
28000
 

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; if the site use antigen-based diagnostic test and RT-PCR test together, subjects with negative antigen-based diagnostic test results can be enrolled at first, and if the RT-PCR result is positive later, the subject should drop out from this study; subjects with positive antigen-based diagnostic test results will be enrolled only wait for the negative result of RT-PCR); 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.
 
71/KEPK-RSUPP/07/2021
ARCoV-005 Versi 2.1, dated 9 November 2021
+62821-1340-5297(Yustina Ari)/ +62857-1618-3552 (Puspa)