Novel Coronavirus Vaccine (CHO cell) Phase III clinical trial

Tahapan Penelitian : Rekrut
Sponsor:
Mitra Pelaksana:
Departemen Ilmu Kesehatan Anak FKUI-RSCM, Jakarta; Departemen Ilmu Kesehatan Anak FK-UNPAD/RSHS, Bandung
No Registry
Tanggal Input Registry : 26-02-2021

26-02-2021
To evaluate the efficacy and safety of the Recombinant Novel Coronavirus Vaccine (CHO Cell) against s any severity of COVID-19 in a population aged 18 years and above. Metric/method of measurement: a. The number of any severity of COVID-9 cases 14 days after whole vaccination. b. Analysis of adverse events from the first dose of vaccination until 30 days after full course of vaccination: incidence of adverse reactions or adverse events; incidence of grade 3 or above adverse reactions or adverse events; incidence of adverse reactions or adverse events leading to withdrawal. c. Analysis of serious adverse events from the first dose of vaccination until 12 months after full course of vaccination: incidence of serious adverse events; incidence of serious adverse events associated with Investigational product.
a. To evaluate the efficacy of the Recombinant Novel Coronavirus Vaccine (CHO Cell) against the severity of severe and above COVID-19 in a population aged 18 years and above. b. To evaluate the immunogenicity and immune persistence of the Recombinant Novel Coronavirus Vaccine (CHO Cell) in a population aged 18 years and above. c. To evaluate the efficacy of the Recombinant Novel Coronavirus Vaccine (CHO Cell) as emergency vaccination against any severity of COVID-9 in a population aged 18 years and above. d. To evaluate the efficacy of the Recombinant Novel Coronavirus Vaccine (CHO Cell) against any severity of COVID-9 in populations of different age group (18-59 years vs. 60 years and above). The metric or method of measurement used (be as specific as possible) a. The number of severe and severity above COVID-19 cases 14 days after whole vaccination; b. The number of any severity of COVID-9 cases after first dose of vaccination; c. The number of COVID-19 cases of any severity in populations of different age group (18-59 years vs. 60 years and above) 14 days after whole vaccination. d. The level of neutralizing antibody to SARS-COV-2 and IgG level of RBD protein binding antibody at 14 days and 6 months after full course of vaccination.
 
Novel Coronavirus Vaccine (CHO cell) Phase III clinical trial
A Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial in 18 Years of Age and Above to Determine the Safety and Efficacy of ZF2001, a Recombinant Novel Coronavirus Vaccine (CHO cell) for Prevention of COVID-19
Eksperimental
Investigational Vaccine: ZF2001 Name : Recombinant Novel Coronavirus Vaccine (CHO cell) Manufacturer : Anhui Zhifei Longcom Biopharmaceutical Co., Ltd Specifications : 0.5ml/vial. It contains 25 μg NCP-RBD protein Ingredients : NCP-RBD, Aluminum Hydroxide Adjuvant Dosage form : injection The injection way: intramuscular injection of deltoid muscle of upper arm Vaccination dose: 0.5ml Vaccination schedule: 0,1,2 months Placebo: Name : Novel Coronavirus Vaccine (CHO cell) placebo (with aluminum) Manufacturer : Anhui Zhifei Longcom Biopharmaceutical Co., Ltd Specifications : 0.5 ml/vial. It contains 0.25mg aluminum hydroxide adjuvant Ingredients : Aluminum hydroxide adjuvant Dosage form : injection The injection way: intramuscular injection of deltoid muscle of upper arm Vaccination dose: 0.5ml Vaccination schedule: 0,1,2 months
4000
 

Inclusion Criteria:

(1) Subjects ≥18 years old; (2) Subjects who voluntarily participate in the study and sign the informed consent form, and can provide the effective identity certificate, understand and follow the requirements of the study protocol; (3) Female subjects of childbearing age who agree to use the effective contraceptive measures from the starting of the study to 2 months after the completed inoculation.

Exclusion Criteria:

(1) Suspected or confirmed as fever (ancillary temperature ≥37.3°C / oral temperature ≥37.5°C) within 72 hours before the enrollment, or ancillary temperature ≥37.3°C / oral temperature ≥37.5°C at the day of screening; (2) Diastolic blood pressure ≥ 100mmhg and / or systolic blood pressure ≥ 150mmhg; (3) Patients with previous history of a COVID-19; (4) Detection of SARS-COV-2 nucleic acid or antibody is positive (in Indonesia, detection of SARS-COV-2 antigen or antibody is positive); (5) Those who are suffering from the following diseases: ① With thrombocytopenia, any coagulation dysfunction or receiving anti-coagulatory treatment ② Congenital or acquired immune deficiency or autoimmune disease history; no spleen, or history of splenic surgery and trauma, or receiving immunomodulator treatment within 6 months, e.g., immunosuppressive dose of glucocorticoids (reference dose: equivalent to 20mg/ day of prednisone, over 1 week); Or monoclonal antibodies; Or thymosin; Or interferon etc.; However, topical application (such as ointment, eye drops, inhalers or nasal sprays) is permitted; ③ Symptoms related to acute respiratory tract infection (such as sneezing, nasal congestion, runny nose, cough, sore throat, loss of taste, chills, shortness of breath, etc.); ④ Cancer patients (except basal cell carcinoma) (6) With a history of serious allergy to any vaccine or any composition of Investigational product (including aluminum preparations), such as allergic shock, allergic throat edema, allergic purpura, thrombocytopenic purpura, localized allergic necrosis reaction (Arthus reaction), dyspnea and angioneuroedema; (7) Inoculated with subunit vaccine and inactivated vaccine within 14 days before the first dosing of investigational vaccine, or inoculated with attenuated live vaccine within 30 days; (8) Previous receiving blood transfusion or blood relevant products (including immunoglobulin) within 3 months, or planning to receive such products from the starting of study to
 
Komite Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Indonesia, Approval No. KET-1492/UN2.F1/ETIK/PPM.00.02/2020, dated 28 Dec 2020; Komite Etik Penelitian Kesehatan Rumah Sakit Umum Pusat Dr. Hasan Sadikin Bandung, Approval No: LB.02.01/X.6.5/13/2021, dated 21 Jan 2021.
No. RG.01.06.1.3.02.21.07, dated 03 Feb 2021
ClinicalTrials.gov Identifier: NCT04646590
Dr. dr. Chairuddin Yunus, M.Kes.; email: Hcy8642@bcht.co.id, Hcy8642@gmail.com