Clinical trial NCT05228613: Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: COVID-19 vaccine
healthy population
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Fakultas Kedokteran Universitas Indonesia
name: Faculty of Medicine, Diponegoro University, Semarang
First posted: 2022-02-08
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.
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 IP immunization.
14. Subjects plan to move from the study area before the end of study period.

Primary outcomes:
measure: Safety of the vaccine within 7 days after each dose
timeFrame: 7 days after each dose
Secondary outcomes:
measure: safety of the vaccine within 28 days after each dose
timeFrame: 28 days after each dose
measure: Serious Adverse Event (SAE) of the vaccine
timeFrame: 6 months after the last dose
measure: Comparison of safety between vaccine and active control
timeFrame: 28 days after each dose and 6 months after the last dose
measure: Deviation of laboratory evaluation
timeFrame: 7 days after the first dose and 14 days after the last dose
measure: Inflammatory factor evaluation
timeFrame: 7 days after the first dose and 14 days after the last dose
measure: Immunogenicity profile after the last dose
timeFrame: 14 days and 28 days after the last dose
measure: Immunogenicity profile after the last dose
timeFrame: 14 days and 28 days after the last dose
measure: Comparison of immunogenicity profile
timeFrame: 14 days and 28 days after the last dose
measure: Comparison of immunogenicity profile
timeFrame: 14 days and 28 days after the last dose
Other outcomes:
measure: Cellular immunity evaluation
timeFrame: 14 days after the last dose
Locations:
city: Semarang
country: Indonesia
facility: Faculty of Medicine, Diponegoro University, Semarang
state: Central Java
city: Jakarta
country: Indonesia
facility: Fakultas Kedokteran Universitas Indonesia
state: Greater Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Prof Rini Sekartini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Diponegoro University, Semarang
name: Yetty Movieta Nency, MD
role: PRINCIPAL_INVESTIGATOR
References: