Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine

A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine 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 of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.

Study Overview

• Status: Completed
• Conditions: Covid19
• 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 60 subjects will be recruited (18 years and above).

The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Greater Jakarta
    • Jakarta, Greater Jakarta, Indonesia
      • Fakultas Kedokteran Universitas Indonesia

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 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 during or 6 months prior to enrollment.
3. Subjects who have history of Covid-19 in the last 3 months (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 rapid antigen test 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.
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 Investigational Product (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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adult - Vaccine candidate; 50 µg dose, adult group (18-59 years)	Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine; intramuscular injection
Active Comparator: Adult - Control; SARS-CoV-2 inactivated vaccine, adult group (18-59 years)	Biological: SARS-CoV-2 Inactivated Vaccine; intramuscular injection
Experimental: Elderly - Vaccine candidate; 50 µg dose, elderly group (> 60 years)	Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine; intramuscular injection
Active Comparator: Elderly - Control; SARS-CoV-2 inactivated vaccine, elderly group (> 60 years)	Biological: SARS-CoV-2 Inactivated Vaccine; intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the SARS-CoV-2 protein subunit recombinant 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 SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose	percentage of subjects with solicited and unsolicited AE	28 days after each dose
Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control	percentage of subjects with AE and SAE between vaccine and active control group	28 days after each dose
Deviation of laboratory evaluation	Any deviation from routine laboratory evaluation that probably related to the dosing	28 days after the first dose
Deviation of laboratory evaluation	Any deviation from routine laboratory evaluation that probably related to the dosing	7 days after whole schedule dose
Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose	seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody	28 days after each dose
Comparison of immunogenicity between 2 and 3 doses	seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody	28 days after second and third dose

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Collaborators: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia; Fakultas Kedokteran Universitas Indonesia
• Investigators: Principal Investigator: Prof. Rini Sekartini, MD, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): August 6, 2022

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: covid19 vaccine
• 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: CoV2-010221

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