Last updated: September 4, 2022
Sponsor: PT. Kimia Farma (Persero) Tbk
Overall Status: Active - Recruiting
Phase
2
Condition
Covid-19
Treatment
N/AClinical Study ID
NCT05172193
BOOST-VC-0221
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult males or females aged 18 years and above at the time of consent.
- Participants who provide a voluntarily consent to participate in the study and signthe consent form.
- Participants who have previously received homologous 2-dose of SARS-COV-2 Vaccine (either Vero Cell inactivated-Sinopharm SARS-COV-2 Vaccine, CoronaVac SARS-COV-2Vaccine, or Cominarty/Pfizer mRNA COVID-19 Vaccine) authorized for emergency use,between 6 to 12 months post second prime vaccine dose prior to Day 1.
- Participants who have negative results for swab SARS-COV-2 rapid antigen test.
Exclusion
Exclusion Criteria:
- Participants who are unable to follow clinical and follow-up procedures.
- Participants with acute fever with temperature above 38℃, coughing, breathingdifficulty, chills, muscle ache, headache, sore throat, loss of smell, or loss oftaste within 72 hours prior to the dosing.
- Participants with a history of PCR-confirmed SARS-CoV-2 infection in the last 90 daysprior to dosing.
- Female who are pregnant or breastfeeding.
- Participants with a history of hypersensitivity or allergic reactions includinganaphylaxis.
- Participants with immune dysfunction, including immunodeficiency disorder, or familyhistory of such conditions, except HIV-positive participants in stable/well-controlledcondition.
- Participants who received chronic administration (defined as more than 14 continuousdays) of immunosuppressant medication such as immunomodulator, immune-modifying drug,immunoglobulin, immunotherapy, chemotherapy, systemic corticosteroid, etc. excepttopical steroids or short-term oral steroids (course lasting ≤ 14 days), orblood-derived products in the last 90 days prior to dosing.
- Participants with a current clinically significant chronic and unstablecardiovascular, endocrine, gastrointestinal, hepatic (including hepatitis B and C),renal, neurological, respiratory, psychiatric or other medical disorders not excludedby other exclusion criteria , that are assessed by the investigator as beingclinically unstable within the prior 90 days as evidenced by:
- Hospitalization for the condition, including day surgical interventions
- New significant organ function deterioration
- Needing addition of new treatments or major dose adjustments of currenttreatments (mild or moderate well-controlled comorbidities are allowed)
- Participants with hemophilia or people using anticoagulants who are at a risk ofserious bleeding from IM injection.
- Participants with a current dependent on antipsychotic drugs and narcotic analgesics,or suspected of alcohol or drug dependency.
- Participants who have received or plans to receive other vaccination(s) within 28 daysprior to or during study duration (except for influenza vaccine which is not allowedwithin 14 days before, or 4 weeks after final dose of IP).
- Participants who have received or have plans to receive other investigational drug(s)while participating in another clinical study or bioequivalence study within 28 daysprior to vaccination. -
Study Design
Total Participants: 600
Study Start date:
December 31, 2021
Estimated Completion Date:
September 30, 2023
Connect with a study center
Universitas Udayana Hospital
Badung, Bali
IndonesiaCompleted
Bali Mandara Hospital
Denpasar, Bali
IndonesiaCompleted
Kimia Farma Soetomo Clinic and Laboratorium
Semarang, Central Java
IndonesiaActive - Recruiting
JIH Hospital
Sleman, D.I. Yogyakarta
IndonesiaCompleted
Kimia Farma Adisucipto Clinic and Laboratorium
Yogyakarta, D.I. Yogyakarta
IndonesiaCompleted
Kimia Farma Diponegoro Clinic and Laboratorium
Bandung, West Java
IndonesiaActive - Recruiting
Kimia Farma Radio Dalam Clinic and Laboratorium
Jakarta,
IndonesiaActive - Recruiting
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