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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05727215
• Other study ID #: CoV2-Booster-Children-0222
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 28, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: August 2023
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: February 28, 2024
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Clinically healthy children 12-17 years of age.

2. 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.

3. 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).

4. Parent and/or legal guardian 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. 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.

6. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.

7. 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.

8. 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)).

9. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.

10. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.

11. Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).

12. Subjects plan to move from the study area before the end of study period.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• SARS-CoV-2 subunit protein recombinant vaccine
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine Universitas Padjadjaran	Bandung	Jawa Barat

Sponsors (2)

Lead Sponsor	Collaborator
PT Bio Farma	Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seropositive rate of the candidate vaccine	Seropositive rate of neutralizing antibody	baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination
Secondary	Seroconversion rate of the candidate vaccine	Seroconversion rate of neutralizing antibody	baseline and 14 days after booster vaccination
Secondary	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
Secondary	Seroconversion rate of candidate vaccine	Seroconversion rate of IgG antibody (RBD)	baseline and 14 days after booster vaccination
Secondary	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
Secondary	Serious Adverse Event (SAE) of the vaccine	Percentage of subjects with at least 1 SAE	until 12 months after booster vaccination