Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

  • STATUS
    Recruiting
  • days left to enroll
    59
  • participants needed
    900
  • sponsor
    PT Bio Farma
Updated on 7 October 2022
Accepts healthy volunteers

Summary

Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.

Description

This trial is observer-blind, randomized, prospective intervention study. In this study 900 subjects who had received complete primary doses of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector (AstraZeneca®) COVID-19 vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial.

Subject will be divided into six groups, each 150 subjects per arm who had received a complete primary dose of inactivated (Sinovac®) vaccine, mRNA (Pfizer®) vaccine, or viral vector (AstraZeneca®) vaccine will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine or active control.

Details
Condition COVID-19
Treatment Active comparator, SARS-CoV-2 subunit protein recombinant vaccine
Clinical Study IdentifierNCT05525208
SponsorPT Bio Farma
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinically healthy adults 18 years of age and older
Subjects who have previously received complete primary series of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion
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

Exclusion Criteria

Subject concomitantly enrolled or scheduled to be enrolled in another trial
Subject who has received booster dose of COVID-19 vaccine
Subject who has history of COVID-19 in the last 3 months (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)
Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results)
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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