Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018

A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Adjuvanted With Alum+CpG 1018) in Healthy Populations Aged 18 Years and Above in Indonesia

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: SARS-CoV-2 protein subunit recombinant vaccine; Biological: SARS-CoV-2 inactivated vaccine

Detailed Description

This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above).

The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Semarang, Central Java, Indonesia
      • Faculty of Medicine, Diponegoro University, Semarang
  • Greater Jakarta
    • Jakarta, Greater Jakarta, Indonesia
      • Fakultas Kedokteran Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinically healthy subjects aged 18 years and above.
2. Subjects have been informed properly regarding the study and signed the informed consent form.
3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. History of vaccination with any investigational product against COVID-19 (based on anamnesis)
3. Subjects who have history of COVID-19 (based on anamnesis or other examinations).
4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. The result of RT-PCR test for SARS-CoV-2 is positive.
6. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
7. Abnormality hematology and biochemical test results (for main study subset).
8. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
9. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
10. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
11. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
12. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
13. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
14. Subjects plan to move from the study area before the end of study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine Candidate Formula A; 2 doses of vaccine candidate formula A administered with 28 days interval (0.5 mL per dose)	Biological: SARS-CoV-2 protein subunit recombinant vaccine; candidate vaccine manufactured by PT. Bio Farma
Experimental: Vaccine Candidate Formula B; 2 doses of vaccine candidate formula B administered with 28 days interval (0.5 mL per dose)	Biological: SARS-CoV-2 protein subunit recombinant vaccine; candidate vaccine manufactured by PT. Bio Farma
Experimental: Vaccine Candidate Formula C; 2 doses of vaccine candidate formula C administered with 28 days interval (0.5 mL per dose)	Biological: SARS-CoV-2 protein subunit recombinant vaccine; candidate vaccine manufactured by PT. Bio Farma
Experimental: Vaccine Candidate Formula D; 2 doses of vaccine candidate formula D administered with 28 days interval (0.5 mL per dose)	Biological: SARS-CoV-2 protein subunit recombinant vaccine; candidate vaccine manufactured by PT. Bio Farma
Active Comparator: Active Control; 2 doses of active control administered with 28 days interval (0.5 mL per dose)	Biological: SARS-CoV-2 inactivated vaccine; active control manufactured by Sinovac Life Sciences Co.Ltd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the vaccine within 7 days after each dose	percentage of subjects with solicited and unsolicited Adverse Events (AE)	7 days after each dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of the vaccine within 28 days after each dose	percentage of subjects with solicited and unsolicited AE	28 days after each dose
Serious Adverse Event (SAE) of the vaccine	percentage of subjects with at least 1 SAE	6 months after the last dose
Comparison of safety between vaccine and active control	percentage of subjects with AE and SAE between vaccine and active control group	28 days after each dose and 6 months after the last dose
Deviation of laboratory evaluation	Any deviation from routine laboratory evaluation that probably related to the dosing	7 days after the first dose and 14 days after the last dose
Inflammatory factor evaluation	The change of interleukin-6 (IL-6) in serum	7 days after the first dose and 14 days after the last dose
Immunogenicity profile after the last dose	GMT of IgG antibody and neutralization antibody	14 days and 28 days after the last dose
Immunogenicity profile after the last dose	seroconversion rate of IgG antibody and neutralization antibody	14 days and 28 days after the last dose
Comparison of immunogenicity profile	GMT of IgG antibody and neutralization antibody	14 days and 28 days after the last dose
Comparison of immunogenicity profile	seroconversion rate of IgG antibody and neutralization antibody	14 days and 28 days after the last dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular immunity evaluation	Positive rate of specific T-cell response	14 days after the last dose

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Collaborators: Fakultas Kedokteran Universitas Indonesia; Faculty of Medicine, Diponegoro University, Semarang
• Investigators: Principal Investigator: Prof Rini Sekartini, MD, Fakultas Kedokteran Universitas Indonesia; Principal Investigator: Yetty Movieta Nency, MD, Faculty of Medicine, Diponegoro University, Semarang

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Actual): August 2, 2022
• Study Completion (Actual): January 24, 2023

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19 vaccine; healthy population
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CoV2-0122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No