Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT05525208 | Completed Phase 2 DMC

• 1 other identifier: CoV2-Booster-0222
• Study Type: interventional
• Target: 696
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19 vaccine; healthy population; Booster

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Seropositive rate of the candidate vaccine

  Baseline, 14 days and 6 months after booster vaccination

• Seroconversion rate of the candidate vaccine

  Baseline and 14 days after booster vaccination

• Seropositive rate and GMT of candidate vaccine

  Baseline, 14 days, and 6 months after booster vaccination

• Seroconversion rate of the candidate vaccine

  baseline and 14 days after booster vaccination

• Comparison of immunogenicity between candidate vaccine and control group

  Baseline, 14 days, and 6 months after booster vaccination

Study Arms (6)

Primary dose of inactivated (Sinovac®) vaccine (1)

EXPERIMENTAL

Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine

Biological: SARS-CoV-2 subunit protein recombinant vaccine

Primary dose of mRNA (Pfizer®) vaccine (1)

EXPERIMENTAL

Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine

Biological: SARS-CoV-2 subunit protein recombinant vaccine

Primary dose of Viral Vector (AstraZeneca®) vaccine (1)

EXPERIMENTAL

Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine

Biological: SARS-CoV-2 subunit protein recombinant vaccine

Primary dose of inactivated (Sinovac®) vaccine (2)

EXPERIMENTAL

Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine

Biological: Active Comparator

Primary dose of mRNA (Pfizer®) vaccine (2)

EXPERIMENTAL

Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine

Biological: Active Comparator

Primary dose of Viral Vector (AstraZeneca®) vaccine (2)

EXPERIMENTAL

Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine

Biological: Active Comparator

Interventions

SARS-CoV-2 subunit protein recombinant vaccine BIOLOGICAL

SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma

Primary dose of Viral Vector (AstraZeneca®) vaccine (1); Primary dose of inactivated (Sinovac®) vaccine (1); Primary dose of mRNA (Pfizer®) vaccine (1)

Active Comparator BIOLOGICAL

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).

Primary dose of Viral Vector (AstraZeneca®) vaccine (2); Primary dose of inactivated (Sinovac®) vaccine (2); Primary dose of mRNA (Pfizer®) vaccine (2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically healthy adults 18 years of age and older.
• Subjects have been informed properly regarding the study and signed the informed consent form.
• Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

You may not qualify if:

• Subject concomitantly enrolled or scheduled to be enrolled in another trial.
• Subject who has received booster dose of COVID-19 vaccine.
• Subject who has history of COVID-19 in the last 3 months (based on anamnesis or other examinations).
• Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
• Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
• History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
• History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
• 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.
• 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)).
• Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
• Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
• Subjects plan to move from the study area before the end of study period.

Sponsors & Collaborators

• PT Bio Farma: lead
• Universitas Padjadjaran: collaborator
• Udayana University: collaborator

Study Sites (2)

Faculty of Medicine Universitas Udayana

Denpasar, Bali, Indonesia

Location

Faculty of Medicine Universitas Padjadjaran

Bandung, West Java, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kusnandi Rusmil, Prof, MD

  Faculty of Medicine Universitas Padjadjaran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Vaccine candidate and active comparator are masking.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: September 1, 2022
• Primary Completion: July 2, 2023
• Study Completion: August 4, 2023
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)