> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-immunogenicity-study-of-covid-19-protein-subunit-5eb4a9c6-f38e-4ad1-90e3-d97652d709b1 > Record changed: 2026-10-13 # Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018 NCT05228613 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) Participants 175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) Lead sponsor PT Bio Farma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) Start date 2022-02-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Short title** Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Dates **Completion date** 2023-01-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **First posted** 2022-02-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Registry last updated** 2023-02-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Primary completion date** 2022-08-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Start date** 2022-02-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Size and sites **Actual participants** 175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Participants** 175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Lead sponsor** PT Bio Farma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Identifiers **Registry ID** NCT05228613 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **ClinicalTrials.gov ID** NCT05228613 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** Observer blind: Investigational Product and Active Comparator are masking. Lot number is masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Outcomes ### Primary outcomes 1. Safety of the vaccine within 7 days after each dose Timeframe: 7 days after each dose percentage of subjects with solicited and unsolicited Adverse Events (AE) ### Secondary outcomes 1. safety of the vaccine within 28 days after each dose Timeframe: 28 days after each dose percentage of subjects with solicited and unsolicited AE 2. Serious Adverse Event (SAE) of the vaccine Timeframe: 6 months after the last dose percentage of subjects with at least 1 SAE 3. Comparison of safety between vaccine and active control Timeframe: 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 4. Deviation of laboratory evaluation Timeframe: 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 5. Inflammatory factor evaluation Timeframe: 7 days after the first dose and 14 days after the last dose The change of interleukin-6 (IL-6) in serum 6. Immunogenicity profile after the last dose Timeframe: 14 days and 28 days after the last dose GMT of IgG antibody and neutralization antibody 7. Immunogenicity profile after the last dose Timeframe: 14 days and 28 days after the last dose seroconversion rate of IgG antibody and neutralization antibody 8. Comparison of immunogenicity profile Timeframe: 14 days and 28 days after the last dose GMT of IgG antibody and neutralization antibody 9. Comparison of immunogenicity profile Timeframe: 14 days and 28 days after the last dose seroconversion rate of IgG antibody and neutralization antibody Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 70 Years **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. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Sites - Faculty of Medicine, Diponegoro University, SemarangSemarang, Indonesia - Fakultas Kedokteran Universitas IndonesiaJakarta, Indonesia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05228613) ## Related records ### Drugs (1) - [Adintrevimab](https://trialight.com/data/asset/adintrevimab-54fe54a2-887b-412b-94e4-d15b7c142b42.md) ### Collaborators (2) - Faculty of Medicine, Diponegoro University, Semarang - Fakultas Kedokteran Universitas Indonesia ### Lead sponsors (1) - [PT Bio Farma](https://trialight.com/data/company/pt-bio-farma-42be2c17-f22a-46e5-8a73-fb239c6d39df.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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