Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine

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

This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above

Study Overview

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

Detailed Description

The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses.

One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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, history of 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 received in the previous 4 weeks a treatment likely to alter the immuneresponse (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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine Candidate Formula 1; 2 doses of vaccine candidate formula 1 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 2; 2 doses of vaccine candidate formula 2 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
Placebo Comparator: Control; 2 doses of placebo administered with 28 days interval (0.5 mL per dose)	Biological: placebo; the placebo is NaCl injection manufactured by PT. Bio Farma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of the candidate vaccine	seroconversion rate of antibody (IgG and neutralization 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	6 months after the last dose
Persistence antibody of vaccine candidate	GMT of antibody (IgG and neutralization antibody)	14 days, 28 days, 3 months, 6 months after the last dose
Persistence antibody of vaccine candidate	seropositive rate of antibody (IgG and neutralization antibody)	14 days, 28 days, 3 months, 6 months after the last dose

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 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
• Other Study ID Numbers: CoV2-020322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No