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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2023-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Vaccine candidate and placebo are masking, lot number is masking

Study Groups

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Vaccine Candidate Formula 1

2 doses of vaccine candidate formula 1 administered with 28 days interval (0.5 mL per dose)

Group Type EXPERIMENTAL

SARS-CoV-2 protein subunit recombinant vaccine

Intervention Type BIOLOGICAL

candidate vaccine manufactured by PT. Bio Farma

Vaccine Candidate Formula 2

2 doses of vaccine candidate formula 2 administered with 28 days interval (0.5 mL per dose)

Group Type EXPERIMENTAL

SARS-CoV-2 protein subunit recombinant vaccine

Intervention Type BIOLOGICAL

candidate vaccine manufactured by PT. Bio Farma

Control

2 doses of placebo administered with 28 days interval (0.5 mL per dose)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

the placebo is NaCl injection manufactured by PT. Bio Farma

Interventions

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SARS-CoV-2 protein subunit recombinant vaccine

candidate vaccine manufactured by PT. Bio Farma

Intervention Type BIOLOGICAL

placebo

the placebo is NaCl injection manufactured by PT. Bio Farma

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes