Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children

Phase 3

Recruiting

• Conditions: Vaccine Adverse Reaction; Vaccine Reaction
• Interventions: Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine; Biological: Active Comparator

• Registration Number: NCT05546502
• Lead Sponsor: PT Bio Farma

Brief Summary

A Phase III, Observer-blind, randomized, active-controlled prospective intervention study

Detailed Description

This trial is randomized, prospective intervention study. A total of 1,050 subjects aged 12-17 years (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial.

The subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study.

Main Study for immunogenicity and safety evaluation.

Exploratory Study for cellular immunity evaluation,

Study Timeline

• Study First Submitted: 2022-09-04
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-19
• Study Start: 2022-10-09
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

1. Clinically healthy children aged 12-17 years.
2. Parent and/or legal guardian has been informed properly regarding the study and signed the informed consent form (and assent for subjects aged 12-17 years).
3. Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.

2. History of vaccination with any COVID-19 vaccine (based on anamnesis).

3. Subjects who have history of COVID-19 in the last 3 months (based on anamnesis).

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVID-19 Protein Subunit Recombinant Vaccine	SARS-CoV-2 Protein Subunit Recombinant Vaccine	2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose)
Active Comparator	Active Comparator	2 doses of Covovax® - administered with 28 days interval (0.5 mL per dose)

Primary Outcome Measures

Name	Time	Method
To evaluate immunogenic non-inferiority immune response of SARS-CoV-2 neutralizing antibody of Bio Farma vaccine compared to vaccine control at 14 days after primary series	14 days after primary series	Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2, measured by neutralization assay (against omicron variant) at 14 days after primary series

Secondary Outcome Measures

Name	Time	Method
To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.	28 days after each dose	local reactions, systemic events
To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine.	14 days after primary series	Seroconversion rate and Seropositive rate of neutralizing antibody at baseline and 14 days after primary series vaccination.
To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).	12 months after primary series	Serious Adverse Event
To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.	28 days after each dose	SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody
To evaluate antibody persistence 3, 6 and 12 months after primary series	3, 6 and 12 months after primary series	SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody

Trial Locations

Locations (10)

Bali Mandara Hospital; 🇮🇩 Denpasar, Bali, Indonesia

Abdoel Moeloek Hospital; 🇮🇩 Bandar Lampung, Lampung, Indonesia

Universitas Udayana Hospital; 🇮🇩 Denpasar, Bali, Indonesia

RSUD Hj. Anna Lasmanah; 🇮🇩 Banjarnegara, Central Java, Indonesia

Rumpin Primary Health Care; 🇮🇩 Bogor, West Java, Indonesia

Duren Seribu Primary Health Care; 🇮🇩 Depok, West Java, Indonesia

Pasir Putih Primary Health Care; 🇮🇩 Depok, West Java, Indonesia

M Djamil Hospital; 🇮🇩 Padang, West Sumatra, Indonesia

Universitas Mataram Hospital; 🇮🇩 Mataram, West Nusa Tenggara, Indonesia

RS Universitas Andalas; 🇮🇩 Padang, West Sumatra, Indonesia