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

PT Bio Farma2 sites in 1 country175 target enrollmentFebruary 16, 2022

ConditionsCOVID-19

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19
Sponsor: PT Bio Farma
Enrollment: 175
Locations: 2
Primary Endpoint: Safety of the vaccine within 7 days after each dose
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018

Detailed Description

This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above). The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.

Registry

clinicaltrials.gov

Start Date

February 16, 2022

End Date

January 24, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

PT Bio Farma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinically healthy subjects aged 18 years and above.
•Subjects have been informed properly regarding the study and signed the informed consent form.
•Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria

•Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
•History of vaccination with any investigational product against COVID-19 (based on anamnesis)
•Subjects who have history of COVID-19 (based on anamnesis or other examinations).
•Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
•The result of RT-PCR test for SARS-CoV-2 is positive.
•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).
•Abnormality hematology and biochemical test results (for main study subset).
•History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
•History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
•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.

Outcomes

Primary Outcomes

Safety of the vaccine within 7 days after each dose

Time Frame: 7 days after each dose

percentage of subjects with solicited and unsolicited Adverse Events (AE)

Secondary Outcomes

Serious Adverse Event (SAE) of the vaccine(6 months after the last dose)
Comparison of immunogenicity profile(14 days and 28 days after the last dose)
safety of the vaccine within 28 days after each dose(28 days after each dose)
Inflammatory factor evaluation(7 days after the first dose and 14 days after the last dose)
Immunogenicity profile after the last dose(14 days and 28 days after the last dose)
Comparison of safety between vaccine and active control(28 days after each dose and 6 months after the last dose)
Deviation of laboratory evaluation(7 days after the first dose and 14 days after the last dose)