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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05228613
Recruitment Status : Recruiting
First Posted : February 8, 2022
Last Update Posted : May 13, 2022
Sponsor:
Collaborators:
Fakultas Kedokteran Universitas Indonesia
Faculty of Medicine, Diponegoro University, Semarang
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
COVID-19 Biological: SARS-CoV-2 protein subunit recombinant vaccine Biological: SARS-CoV-2 inactivated vaccine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Observer blind: Investigational Product and Active Comparator are masking. Lot number is masking
Primary Purpose: Treatment
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
Actual Study Start Date : February 16, 2022
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaccine Candidate Formula A
2 doses of vaccine candidate formula A administered with 28 days interval (0.5 mL per dose)
Biological: SARS-CoV-2 protein subunit recombinant vaccine
candidate vaccine manufactured by PT. Bio Farma

Experimental: Vaccine Candidate Formula B
2 doses of vaccine candidate formula B administered with 28 days interval (0.5 mL per dose)
Biological: SARS-CoV-2 protein subunit recombinant vaccine
candidate vaccine manufactured by PT. Bio Farma

Experimental: Vaccine Candidate Formula C
2 doses of vaccine candidate formula C administered with 28 days interval (0.5 mL per dose)
Biological: SARS-CoV-2 protein subunit recombinant vaccine
candidate vaccine manufactured by PT. Bio Farma

Experimental: Vaccine Candidate Formula D
2 doses of vaccine candidate formula D administered with 28 days interval (0.5 mL per dose)
Biological: SARS-CoV-2 protein subunit recombinant vaccine
candidate vaccine manufactured by PT. Bio Farma

Active Comparator: Active Control
2 doses of active control administered with 28 days interval (0.5 mL per dose)
Biological: SARS-CoV-2 inactivated vaccine
active control manufactured by Sinovac Life Sciences Co.Ltd




Primary Outcome Measures :
  1. Safety of the vaccine within 7 days after each dose [ Time Frame: 7 days after each dose ]
    percentage of subjects with solicited and unsolicited Adverse Events (AE)


Secondary Outcome Measures :
  1. safety of the vaccine within 28 days after each dose [ Time Frame: 28 days after each dose ]
    percentage of subjects with solicited and unsolicited AE

  2. Serious Adverse Event (SAE) of the vaccine [ Time Frame: 6 months after the last dose ]
    percentage of subjects with at least 1 SAE

  3. Comparison of safety between vaccine and active control [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 14 days and 28 days after the last dose ]
    GMT of IgG antibody and neutralization antibody

  7. Immunogenicity profile after the last dose [ Time Frame: 14 days and 28 days after the last dose ]
    seroconversion rate of IgG antibody and neutralization antibody

  8. Comparison of immunogenicity profile [ Time Frame: 14 days and 28 days after the last dose ]
    GMT of IgG antibody and neutralization antibody

  9. Comparison of immunogenicity profile [ Time Frame: 14 days and 28 days after the last dose ]
    seroconversion rate of IgG antibody and neutralization antibody


Other Outcome Measures:
  1. Cellular immunity evaluation [ Time Frame: 14 days after the last dose ]
    Positive rate of specific T-cell response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05228613


Contacts
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Contact: Rini Mulia Sari, MD +6222-2033755 ext 14102 rini.mulia@biofarma.co.id

Locations
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Indonesia
Faculty of Medicine, Diponegoro University, Semarang Recruiting
Semarang, Central Java, Indonesia
Contact: Yetty Movieta Nency, MD    +62024 76928010    yettymn@yahoo.com   
Principal Investigator: Yetty Movieta Nency, MD         
Fakultas Kedokteran Universitas Indonesia Recruiting
Jakarta, Greater Jakarta, Indonesia
Contact: Prof Rini Sekartini, MD    +6221-4894932    rsekartini@yahoo.com   
Principal Investigator: Prof Rini Sekartini, MD         
Sponsors and Collaborators
PT Bio Farma
Fakultas Kedokteran Universitas Indonesia
Faculty of Medicine, Diponegoro University, Semarang
Investigators
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Principal Investigator: Prof Rini Sekartini, MD Fakultas Kedokteran Universitas Indonesia
Principal Investigator: Yetty Movieta Nency, MD Faculty of Medicine, Diponegoro University, Semarang
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Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT05228613    
Other Study ID Numbers: CoV2-0122
First Posted: February 8, 2022    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PT Bio Farma:
COVID-19 vaccine
healthy population
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs