Heterologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine in Children 12-17 Years of Age

NCT05727215 | Completed Phase 2 DMC

• 1 other identifier: CoV2-Booster-Children-0222
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate immune response and safety of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac) as a heterologous booster dose in healthy children 12-17 years of age. Participants who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine will be given IndoVac as a booster dose.

Conditions

COVID-19

Keywords

COVID-19 vaccine; healthy population; Booster; Heterologous; Children

Outcome Measures

Primary Outcomes (1)

• Immunogenicity of the candidate vaccine

  Geometric Mean Titer (GMT) and GMFR of neutralizing antibody to the SARS-CoV-2

  14 days after booster vaccination

Secondary Outcomes (6)

• Seropositive rate of the candidate vaccine

  baseline, 14 days, 3 months, 6 months, and 12 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, 3 months, 6 months, and 12 months after booster vaccination

• Seroconversion rate of candidate vaccine

  baseline and 14 days after booster vaccination

• Safety of the candidate vaccine

  30 minutes, 7 days, 28 days, and until 12 months after booster vaccination

Study Arms (1)

Primary dose of inactivated (Sinovac®) vaccine

EXPERIMENTAL

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

Biological: SARS-CoV-2 subunit protein recombinant vaccine

Interventions

SARS-CoV-2 subunit protein recombinant vaccine BIOLOGICAL

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

Primary dose of inactivated (Sinovac®) vaccine

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Clinically healthy children 12-17 years of age.
• Parent/legal guardian and subject has been informed properly regarding the study, and signed the informed consent form (parent/legal guardian) and assent form (subject).
• Parent and/or legal guardian 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).
• 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.
• 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.
• Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
• Subjects plan to move from the study area before the end of study period.

Sponsors & Collaborators

• PT Bio Farma: lead
• Universitas Padjadjaran: collaborator

Study Sites (1)

Faculty of Medicine Universitas Padjadjaran

Bandung, West Java, 40161, 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

• Eddy Fadlyana, MD

  Universitas Padjadjaran

  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: February 13, 2023
• First Posted: February 14, 2023
• Study Start: February 28, 2023
• Primary Completion: February 22, 2024
• Study Completion: March 18, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-06

Locations

ID (1)