Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
- Conditions
- COVID-19
- Interventions
- Biological: SARS-CoV-2 inactivated vaccineBiological: SARS-CoV-2 protein subunit recombinant vaccine
- Registration Number
- NCT05228613
- Lead Sponsor
- PT Bio Farma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- 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.
- 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.
- 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)).
- Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
- Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
- Subjects plan to move from the study area before the end of study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Control SARS-CoV-2 inactivated vaccine 2 doses of active control administered with 28 days interval (0.5 mL per dose) Vaccine Candidate Formula B SARS-CoV-2 protein subunit recombinant vaccine 2 doses of vaccine candidate formula B administered with 28 days interval (0.5 mL per dose) Vaccine Candidate Formula C SARS-CoV-2 protein subunit recombinant vaccine 2 doses of vaccine candidate formula C administered with 28 days interval (0.5 mL per dose) Vaccine Candidate Formula A SARS-CoV-2 protein subunit recombinant vaccine 2 doses of vaccine candidate formula A administered with 28 days interval (0.5 mL per dose) Vaccine Candidate Formula D SARS-CoV-2 protein subunit recombinant vaccine 2 doses of vaccine candidate formula D administered with 28 days interval (0.5 mL per dose)
- Primary Outcome Measures
Name Time Method Safety of the vaccine within 7 days after each dose 7 days after each dose percentage of subjects with solicited and unsolicited Adverse Events (AE)
- Secondary Outcome Measures
Name Time Method Serious Adverse Event (SAE) of the vaccine 6 months after the last dose percentage of subjects with at least 1 SAE
Comparison of immunogenicity profile 14 days and 28 days after the last dose seroconversion rate of IgG antibody and neutralization antibody
Immunogenicity profile after the last dose 14 days and 28 days after the last dose seroconversion rate of IgG antibody and neutralization antibody
safety of the vaccine within 28 days after each dose 28 days after each dose percentage of subjects with solicited and unsolicited AE
Inflammatory factor evaluation 7 days after the first dose and 14 days after the last dose The change of interleukin-6 (IL-6) in serum
Comparison of safety between vaccine and active control 28 days after each dose and 6 months after the last dose percentage of subjects with AE and SAE between vaccine and active control group
Deviation of laboratory evaluation 7 days after the first dose and 14 days after the last dose Any deviation from routine laboratory evaluation that probably related to the dosing
Trial Locations
- Locations (2)
Faculty of Medicine, Diponegoro University, Semarang
🇮🇩Semarang, Central Java, Indonesia
Fakultas Kedokteran Universitas Indonesia
🇮🇩Jakarta, Greater Jakarta, Indonesia