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Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018

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

NCT05228613•PT Bio Farma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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 investigational product against COVID-19 (based on anamnesis)
•3. Subjects who have history of COVID-19 (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 RT-PCR test for SARS-CoV-2 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 (for main study subset).
•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.
+4 more criteria

Locations (2)

Faculty of Medicine, Diponegoro University, Semarang

Semarang, Central Java, Indonesia

Fakultas Kedokteran Universitas Indonesia

Jakarta, Greater Jakarta, Indonesia

Key Dates

Start Date

February 16, 2022

Primary Completion Date

August 2, 2022

Completion Date

January 24, 2023

Last Updated

February 27, 2023

Enrollment

175

ACTUAL participants

Conditions

COVID-19

Interventions

SARS-CoV-2 protein subunit recombinant vaccine

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018

Inclusion Criteria

Exclusion Criteria

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