Homologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT05933278 | Completed Phase 2 DMC

• 1 other identifier: CoV2-Booster 0323
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, prospective intervention study of IndoVac® as a single, homologous booster dose

Conditions

COVID-19

Keywords

COVID-19 vaccine; Booster

Outcome Measures

Primary Outcomes (1)

• Neutralizing antibody before and at 14 days after booster dose

  Geometric Mean Titer (GMT) and Geometric Mean Fold Ratio (GMFR) of SARS-CoV-2 neutralizing antibody against Omicron variant

  Baseline, 14 days after booster dose

Secondary Outcomes (4)

• Neutralizing antibody at 28 days after booster dose

  Baseline, 14 days, 28 days after booster dose

• RBD-binding IgG antibody before, at 14 days and 28 days after booster dose

  Baseline, 14 days, 28 days after booster dose

• Antibody persistence at 3, 6, and 12 months after booster dose

  Baseline, 3 months, 6 months, 12 months after booster dose

• Safety after booster dose

  Baseline to 12 months after booster dose

Study Arms (1)

Participants who previously completed primary doses of vaccine

EXPERIMENTAL

Participants who previously completed primary doses of vaccine

Biological: SARS-CoV-2 Subunit Recombinant Protein Vaccine

Interventions

SARS-CoV-2 Subunit Recombinant Protein Vaccine BIOLOGICAL

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

Participants who previously completed primary doses of vaccine

Eligibility Criteria

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

You may qualify if:

• Clinically healthy subjects aged 18 years and above.
• 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:

• Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
• Subjects had received booster dose of COVID-19 vaccine.
• History of COVID-19 within 3 months prior to enrollment (based on anamnesis or other examinations).
• Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5°C, 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 uncontrolled asthma, 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 or diabetes, liver or kidney diseases, malignant tumors, etc.) which according to the investigator might interfere with the assessment of the trial objectives.
• History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks had received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long- term corticosteroid therapy (\> 2 weeks)).
• History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain- Barre Syndrome.
• Subjects had received any vaccination (other than COVID-19 vaccine) within 1 month before IP immunization.
• Subjects plan to move from the study area before the end of study period.

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (1)

Faculty of Medicine Diponegoro University

Semarang, Central 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

• Yetty Movieta Nency, MD

  Faculty of Medicine Universitas Diponegoro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 6, 2023
• Study Start: July 25, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 5, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)