Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

COVID-19 Clinical Trial

Official title:

Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax - Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05433285
• Other study ID #: CoV2-IB-0322
• Status: Completed
• Phase: Phase 3
• Start date: June 7, 2022
• Est. completion date: August 31, 2023

Study information

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

Clinical Trial Summary

Observer-blind, randomized, active-controlled prospective intervention study

Description:

This trial is randomized, prospective intervention study. A total of 4,050 subjects (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 three study subsets, namely Main Study I, Main Study II, and Exploratory Study: Main Study I for immunogenicity and safety evaluation, Main Study II for safety evaluation, and Exploratory Study for cellular immunity evaluation, with trial design as follow : - Main Study I, Exploratory Study subset: Observer-blind, randomized, active-controlled prospective intervention study - Main Study II: Open-label, randomized study to evaluate safety I

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4050
• Est. completion date: August 31, 2023
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinically healthy subjects aged 18 years and above.

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

3. Subjects 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.

3. History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.

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 uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.

7. History of 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. History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (> 2 weeks)).

10. 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:
• COVID-19 Protein Subunit Recombinant Vaccine
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
• Active Comparator
Covovax® COVID-19 vaccine is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 betacoronavirus

Locations

Country	Name	City	State
Indonesia	Fakultas Kedokteran Universitas Indonesia	Jakarta	Greater Jakarta
Indonesia	Faculty of Medicine Universitas Hassanudin	Makassar	South Sulawesi
Indonesia	Faculty of Medicine Universitas Andalas	Padang	West Sumatera
Indonesia	Faculty of Medicine Diponegoro University	Semarang	Central Java

Sponsors (5)

Lead Sponsor	Collaborator
PT Bio Farma	Faculty of Medicine Universitas Andalas, Faculty of Medicine Universitas Diponegoro, Faculty of Medicine Universitas Hassanudin, Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cellular immunity of candidate vaccine	Positive rate of specific T-cell response	14 days, 6 months and 12 months after two-dose primary series.
Primary	Immunogenicity of the candidate vaccine	Geometric Mean Titers (GMT) of neutralizing antibody	14 days after the last dose
Primary	Seroconversion rate of the candidate vaccine	Seroconversion rate of neutralizing antibody	14 days after the last dose
Secondary	Safety of the candidate vaccine	percentage of subjects with solicited and unsolicited Adverse Events (AE)	28 days after each dose
Secondary	Serious Adverse Event (SAE) of the vaccine	percentage of subjects with at least 1 SAE	12 months after the last dose
Secondary	Persistence neutralizing antibody of vaccine candidate	GMT of neutralization antibody	28 days, 3 months, 6 months and 12 months after the last dose
Secondary	Persistence Immunoglobulin G (IgG) antibody of vaccine candidate	GMT of IgG antibody (RBD)	14 days, 28 days, 3 months, 6 months and 12 months after the last dose