Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

COVID-19 Clinical Trial

Official title:

Observer-Blind, Randomized, Controlled Study of Immunogenicity and Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525208
• Other study ID #: CoV2-Booster-0222
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: September 2022
• Source: PT Bio Farma
• Contact: Rini M. Sari, MD
• Phone: +6222-2033755
• Email: rini.mulia[@]biofarma.co.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.

Description:

This trial is observer-blind, randomized, prospective intervention study. In this study 900 subjects who had received complete primary doses of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector (AstraZeneca®) COVID-19 vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial.

Subject will be divided into six groups, each 150 subjects per arm who had received a complete primary dose of inactivated (Sinovac®) vaccine, mRNA (Pfizer®) vaccine, or viral vector (AstraZeneca®) vaccine will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine or active control.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: March 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinically healthy adults 18 years of age and older.

2. Subjects who have previously received complete primary series of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion.

3. Subjects have been informed properly regarding the study and signed the informed consent form.

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

6. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.

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

8. 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.

9. 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)).

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

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

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
• Active Comparator
The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine Universitas Padjadjaran	Bandung	West Java
Indonesia	Faculty of Medicine Universitas Udayana	Denpasar	Bali

Sponsors (3)

Lead Sponsor	Collaborator
PT Bio Farma	Udayana University, 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 GMT ratio 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 and 6 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 candidate vaccine	Baseline, 14 days, and 6 months after booster vaccination
Secondary	Seroconversion rate of the candidate vaccine	Seroconversion rate of IgG antibody (RBD)	baseline and 14 days after booster vaccination
Secondary	Comparison of immunogenicity between candidate vaccine and control group	Comparison of GMT, seroconversion rate, seropositive rate of neutralizing antibody and IgG antibody (RBD) between candidate vaccine and control group	Baseline, 14 days, and 6 months after booster vaccination
Secondary	Safety of the candidate vaccine	Percentage of subjects with solicited and unsolicited Adverse Events (AE)	28 days after booster vaccination
Secondary	Serious Adverse Event (SAE) of the vaccine	Percentage of subjects with at least 1 SAE	6 months after booster vaccination