Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax - Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III)

Observer-blind, randomized, active-controlled prospective intervention study

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: COVID-19 Protein Subunit Recombinant Vaccine; Biological: Active Comparator

Detailed Description

This trial is randomized, prospective intervention study. A total of 4,050 subjects (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. The subjects will be divided into three study subsets, namely Main Study I, Main Study II, and Exploratory Study: Main Study I for immunogenicity and safety evaluation, Main Study II for safety evaluation, and Exploratory Study for cellular immunity evaluation, with trial design as follow :

• Main Study I, Exploratory Study subset: Observer-blind, randomized, active-controlled prospective intervention study
• Main Study II: Open-label, randomized study to evaluate safety I

• Study Type: Interventional
• Enrollment (Actual): 4050
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Semarang, Central Java, Indonesia
      • Faculty of Medicine Diponegoro University
  • Greater Jakarta
    • Jakarta, Greater Jakarta, Indonesia
      • Fakultas Kedokteran Universitas Indonesia
  • South Sulawesi
    • Makassar, South Sulawesi, Indonesia
      • Faculty of Medicine Universitas Hassanudin
  • West Sumatera
    • Padang, West Sumatera, Indonesia
      • Faculty of Medicine Universitas Andalas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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 COVID-19 vaccine.
3. History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.
4. Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
6. History of uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
7. History of blood disorders contraindicating intramuscular injection.
8. 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.
9. History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (> 2 weeks)).
10. History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
11. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
12. 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: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVID-19 Protein Subunit Recombinant Vaccine; 2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose)	Biological: COVID-19 Protein Subunit Recombinant Vaccine; SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Active Comparator: Active Comparator; 2 doses of Covovax® - recombinant spike protein Nanoparticle Vaccine, administered with 28 days interval (0.5 mL per dose)	Biological: Active Comparator; Covovax® COVID-19 vaccine is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 betacoronavirus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of the candidate vaccine	Geometric Mean Titers (GMT) of neutralizing antibody	14 days after the last dose
Seroconversion rate of the candidate vaccine	Seroconversion rate of neutralizing antibody	14 days after the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the candidate vaccine	percentage of subjects with solicited and unsolicited Adverse Events (AE)	28 days after each dose
Serious Adverse Event (SAE) of the vaccine	percentage of subjects with at least 1 SAE	12 months after the last dose
Persistence neutralizing antibody of vaccine candidate	GMT of neutralization antibody	28 days, 3 months, 6 months and 12 months after the last dose
Persistence Immunoglobulin G (IgG) antibody of vaccine candidate	GMT of IgG antibody (RBD)	14 days, 28 days, 3 months, 6 months and 12 months after the last dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular immunity of candidate vaccine	Positive rate of specific T-cell response	14 days, 6 months and 12 months after two-dose primary series.

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Collaborators: Fakultas Kedokteran Universitas Indonesia; Faculty of Medicine Universitas Diponegoro; Faculty of Medicine Universitas Andalas; Faculty of Medicine Universitas Hassanudin
• Investigators: Principal Investigator: Prof. Dr. Soedjatmiko SpA(K), MSi, MD, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19 vaccine; healthy population; naive participants
• 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
• Other Study ID Numbers: CoV2-IB-0322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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