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

Study Overview
=================
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.

Detailed Description
-----------------
This trial is open label prospective intervention study. In this study 150 subjects who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial. Subject will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac).

Official Title
-----------------
Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: SARS-CoV-2 subunit protein recombinant vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically healthy children 12-17 years of age. Subjects who have previously received complete primary series of inactivated (Sinovac®) COVID-19 vaccine with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion. 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary dose of inactivated (Sinovac®) vaccine<br>Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine | Biological: SARS-CoV-2 subunit protein recombinant vaccine<br>* SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seropositive rate of the candidate vaccine | Seropositive rate of neutralizing antibody | baseline, 14 days, 3 months, 6 months, and 12 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 IgG antibody (RBD) | baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination | 
| Seroconversion rate of candidate vaccine | Seroconversion rate of IgG antibody (RBD) | baseline and 14 days after booster vaccination | 
| Safety of the candidate vaccine | Percentage of subjects with solicited and unsolicited Adverse Events (AE) | 30 minutes, 7 days, 28 days, and until 12 months after booster vaccination | 
| Serious Adverse Event (SAE) of the vaccine | Percentage of subjects with at least 1 SAE | until 12 months after booster vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 vaccine, healthy population, Booster, Heterologous, Children