Safety and Immunogenicity of SARS-CoV-2 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

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2022-08-06

Brief Summary

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The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.

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Detailed Description

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This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above).

The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Observer blind: Investigational Product and Active Comparator are masking. Lot number is masking

Study Groups

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Adult - Vaccine candidate

50 µg dose, adult group (18-59 years)

Group Type EXPERIMENTAL

SARS-CoV-2 Protein Subunit Recombinant Vaccine

Intervention Type BIOLOGICAL

intramuscular injection

Adult - Control

SARS-CoV-2 inactivated vaccine, adult group (18-59 years)

Group Type ACTIVE_COMPARATOR

SARS-CoV-2 Inactivated Vaccine

Intervention Type BIOLOGICAL

intramuscular injection

Elderly - Vaccine candidate

50 µg dose, elderly group (\> 60 years)

Group Type EXPERIMENTAL

SARS-CoV-2 Protein Subunit Recombinant Vaccine

Intervention Type BIOLOGICAL

intramuscular injection

Elderly - Control

SARS-CoV-2 inactivated vaccine, elderly group (\> 60 years)

Group Type ACTIVE_COMPARATOR

SARS-CoV-2 Inactivated Vaccine

Intervention Type BIOLOGICAL

intramuscular injection

Interventions

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SARS-CoV-2 Protein Subunit Recombinant Vaccine

intramuscular injection

Intervention Type BIOLOGICAL

SARS-CoV-2 Inactivated Vaccine

intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 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 investigational product against Covid-19 during or 6 months prior to enrollment.
3. Subjects who have 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. The result of rapid antigen test is positive.
6. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
7. Abnormality hematology and biochemical test results.
8. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
9. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
10. 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.
11. 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)).
12. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
13. Subjects receive any vaccination (other than Covid-19 vaccine) within 1 month before and after Investigational Product (IP) immunization.
14. 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