Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

Observer-Blind, Randomized, Controlled Study of Immunogenicity and Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older

Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: SARS-CoV-2 subunit protein recombinant vaccine; Biological: Active Comparator

Detailed Description

This trial is observer-blind, randomized, prospective intervention study. In this study 900 subjects who had received complete primary doses of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector (AstraZeneca®) COVID-19 vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial.

Subject will be divided into six groups, each 150 subjects per arm who had received a complete primary dose of inactivated (Sinovac®) vaccine, mRNA (Pfizer®) vaccine, or viral vector (AstraZeneca®) vaccine will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine or active control.

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rini M. Sari, MD; Phone Number: +6222-2033755; Email: rini.mulia@biofarma.co.id

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia
      • Recruiting
      • Faculty of Medicine Universitas Udayana
      • Contact: I Gusti Ayu T. Wardani, MD; Phone Number: 081338799222
      • Principal Investigator: I Gusti Ayu T. Wardani, MD
  • West Java
    • Bandung, West Java, Indonesia
      • Recruiting
      • Faculty of Medicine Universitas Padjadjaran
      • Contact: Kusnandi Rusmil, Prof, MD; Phone Number: 0811232774
      • Principal Investigator: Kusnandi Rusmil, Prof, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinically healthy adults 18 years of age and older.
2. Subjects who have previously received complete primary series of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion.
3. Subjects have been informed properly regarding the study and signed the informed consent form.
4. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
2. Subject who has received booster dose of COVID-19 vaccine.
3. Subject who has 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. 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 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 uncontrolled coagulopathy or 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. 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)).
10. Subjects who have 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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary dose of inactivated (Sinovac®) vaccine (1); Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine	Biological: SARS-CoV-2 subunit protein recombinant vaccine; SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Experimental: Primary dose of mRNA (Pfizer®) vaccine (1); Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine	Biological: SARS-CoV-2 subunit protein recombinant vaccine; SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Experimental: Primary dose of Viral Vector (AstraZeneca®) vaccine (1); Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine	Biological: SARS-CoV-2 subunit protein recombinant vaccine; SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Experimental: Primary dose of inactivated (Sinovac®) vaccine (2); Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine	Biological: Active Comparator; The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).
Experimental: Primary dose of mRNA (Pfizer®) vaccine (2); Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine	Biological: Active Comparator; The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).
Experimental: Primary dose of Viral Vector (AstraZeneca®) vaccine (2); Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine	Biological: Active Comparator; The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of the candidate vaccine	Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2	14 days after booster vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seropositive rate of the candidate vaccine	Seropositive rate of neutralizing antibody	Baseline, 14 days and 6 months after booster vaccination
Seroconversion rate of the candidate vaccine	Seroconversion rate of neutralizing antibody	Baseline and 14 days after booster vaccination
Seropositive rate and GMT of candidate vaccine	Seropositive rate and GMT of candidate vaccine	Baseline, 14 days, and 6 months after booster vaccination
Seroconversion rate of the candidate vaccine	Seroconversion rate of IgG antibody (RBD)	baseline and 14 days after booster vaccination
Comparison of immunogenicity between candidate vaccine and control group	Comparison of GMT, seroconversion rate, seropositive rate of neutralizing antibody and IgG antibody (RBD) between candidate vaccine and control group	Baseline, 14 days, and 6 months after booster vaccination
Safety of the candidate vaccine	Percentage of subjects with solicited and unsolicited Adverse Events (AE)	28 days after booster vaccination
Serious Adverse Event (SAE) of the vaccine	Percentage of subjects with at least 1 SAE	6 months after booster vaccination

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Collaborators: Udayana University; Universitas Padjadjaran
• Investigators: Principal Investigator: Kusnandi Rusmil, Prof, MD, Faculty of Medicine Universitas Padjadjaran

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Booster; 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-Booster-0222

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