Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
- 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
- Short title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-01-24
- First posted
- 2022-02-08
- Registry last updated
- 2023-02-27
- Primary completion date
- 2022-08-02
- Start date
- 2022-02-16
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- PT Bio Farma
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05228613
- ClinicalTrials.gov ID
- NCT05228613
- Registry record
- Open registry record
- 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
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)
safety of the vaccine within 28 days after each dose
Timeframe: 28 days after each dose
percentage of subjects with solicited and unsolicited AE
Serious Adverse Event (SAE) of the vaccine
Timeframe: 6 months after the last dose
percentage of subjects with at least 1 SAE
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
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
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
Immunogenicity profile after the last dose
Timeframe: 14 days and 28 days after the last dose
GMT of IgG antibody and neutralization antibody
Immunogenicity profile after the last dose
Timeframe: 14 days and 28 days after the last dose
seroconversion rate of IgG antibody and neutralization antibody
Comparison of immunogenicity profile
Timeframe: 14 days and 28 days after the last dose
GMT of IgG antibody and neutralization antibody
Comparison of immunogenicity profile
Timeframe: 14 days and 28 days after the last dose
seroconversion rate of IgG antibody and neutralization antibody
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Healthy volunteers
- Yes
- 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.
- Faculty of Medicine, Diponegoro University, SemarangSemarang, Indonesia
- Fakultas Kedokteran Universitas IndonesiaJakarta, Indonesia
Related records
Drugs (1)
Collaborators (2)
- Faculty of Medicine, Diponegoro University, Semarang
- Fakultas Kedokteran Universitas Indonesia
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition