Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT05433285
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Phase
Phase 3
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Recruitment status
Completed
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Participants
4,050
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Lead sponsor
PT Bio Farma
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Start date
2022-06-07
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Number of sites
4
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Summary
Observer-blind, randomized, active-controlled prospective intervention study
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Short title
Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine
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Official title
Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax - Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2023-08-31
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First posted
2022-06-27
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Registry last updated
2023-11-29
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Primary completion date
2022-08-05
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Start date
2022-06-07
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Actual participants
4,050
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Participants
4,050
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
4
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
PT Bio Farma
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05433285
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ClinicalTrials.gov ID
NCT05433285
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Double masking
Masking description
Vaccine candidate and active comparator are masking, lot number is masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Immunogenicity of the candidate vaccine

    Timeframe: 14 days after the last dose

    Geometric Mean Titers (GMT) of neutralizing antibody

  2. Seroconversion rate of the candidate vaccine

    Timeframe: 14 days after the last dose

    Seroconversion rate of neutralizing antibody

  1. Safety of the candidate vaccine

    Timeframe: 28 days after each dose

    percentage of subjects with solicited and unsolicited Adverse Events (AE)

  2. Serious Adverse Event (SAE) of the vaccine

    Timeframe: 12 months after the last dose

    percentage of subjects with at least 1 SAE

  3. Persistence neutralizing antibody of vaccine candidate

    Timeframe: 28 days, 3 months, 6 months and 12 months after the last dose

    GMT of neutralization antibody

  4. Persistence Immunoglobulin G (IgG) antibody of vaccine candidate

    Timeframe: 14 days, 28 days, 3 months, 6 months and 12 months after the last dose

    GMT of IgG antibody (RBD)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  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.

  1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
  2. History of vaccination with any COVID-19 vaccine.
  3. History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.
  4. Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
  5. Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
  6. History of uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
  7. History of blood disorders contraindicating intramuscular injection.
  8. 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.
  9. History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (> 2 weeks)).
  10. History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
  11. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
  12. Subjects plan to move from the study area before the end of study period.
Sources for eligibility
clinicaltrials.gov

  • Faculty of Medicine Diponegoro UniversitySemarang, Indonesia
  • Fakultas Kedokteran Universitas IndonesiaJakarta, Indonesia
  • Faculty of Medicine Universitas HassanudinMakassar, Indonesia
  • Faculty of Medicine Universitas AndalasPadang, Indonesia
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (4)

Lead sponsors (1)

Conditions (1)

Targets (1)