Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine

COVID-19 Clinical Trial

Official title:

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313035
• Other study ID #: CoV2-020322
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 13, 2022
• Est. completion date: February 28, 2023

Study information

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

Clinical Trial Summary

This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above

Description:

The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses. One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: February 28, 2023
• Est. primary completion date: July 22, 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, history of 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 received in the previous 4 weeks a treatment likely to alter the immuneresponse (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:
• SARS-CoV-2 protein subunit recombinant vaccine
candidate vaccine manufactured by PT. Bio Farma
• placebo
the placebo is NaCl injection manufactured by PT. Bio Farma

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
PT Bio Farma	Faculty of Medicine, Diponegoro University, Semarang, Faculty of Medicine, Universitas Andalas, Padang, Faculty of Medicine, Universitas Hassanudin, Makassar, Faculty of Medicine, Universitas Indonesia, Jakarta

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity of the candidate vaccine	seroconversion rate of antibody (IgG and neutralization 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	6 months after the last dose
Secondary	Persistence antibody of vaccine candidate	GMT of antibody (IgG and neutralization antibody)	14 days, 28 days, 3 months, 6 months after the last dose
Secondary	Persistence antibody of vaccine candidate	seropositive rate of antibody (IgG and neutralization antibody)	14 days, 28 days, 3 months, 6 months after the last dose