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

Vaccine Reaction Clinical Trial

Official title:

A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546502
• Other study ID #: CoV2-Children-0322
• Status: Recruiting
• Phase: Phase 3
• Start date: October 9, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2023
• Source: PT Bio Farma
• Contact: Rini Mulia Sari, MD
• Phone: 0222033755
• Email: rini.mulia[@]biofarma.co.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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).

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

Related Conditions & MeSH terms

• Vaccine Adverse Reaction
• Vaccine Reaction

Intervention

Biological:
• SARS-CoV-2 Protein Subunit Recombinant Vaccine
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
• Active Comparator
Covovax

Locations

Country	Name	City	State
Indonesia	Abdoel Moeloek Hospital	Bandar Lampung	Lampung
Indonesia	RSUD Hj. Anna Lasmanah	Banjarnegara	Central Java
Indonesia	Rumpin Primary Health Care	Bogor	West Java
Indonesia	Bali Mandara Hospital	Denpasar	Bali
Indonesia	Universitas Udayana Hospital	Denpasar	Bali
Indonesia	Duren Seribu Primary Health Care	Depok	West Java
Indonesia	Pasir Putih Primary Health Care	Depok	West Java
Indonesia	Universitas Mataram Hospital	Mataram	West Nusa Tenggara
Indonesia	M Djamil Hospital	Padang	West Sumatra
Indonesia	RS Universitas Andalas	Padang	West Sumatra

Sponsors (4)

Lead Sponsor	Collaborator
PT Bio Farma	Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM, Cipto Mangunkusumo Hospital/Department of Child Health, Faculty of Medicine, University of Indonesia, Jakarta, Faculty of Medicine, Andalas University

Country where clinical trial is conducted

Indonesia, 

Outcome

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