Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

Last updated: June 2, 2025
Sponsor: PT Bio Farma
Overall Status: Completed

Phase

2

Condition

Covid-19

Treatment

SARS-CoV-2 subunit protein recombinant vaccine

Active Comparator

Clinical Study ID

NCT05525208
CoV2-Booster-0222
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinically healthy adults 18 years of age and older.

  2. Subjects who have previously received complete primary series of authorized/approvedinactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior toinclusion but not longer than 12 months prior to inclusion.

  3. Subjects have been informed properly regarding the study and signed the informedconsent form.

  4. Subjects will commit to comply with the instructions of the investigator and theschedule of the trial.

Exclusion

Exclusion Criteria:

  1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.

  2. Subject who has received booster dose of COVID-19 vaccine.

  3. Subject who has history of COVID-19 in the last 3 months (based on anamnesis orother examinations).

  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 asthma, history of allergy to vaccines or vaccine ingredients, and severeadverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.

  7. History of uncontrolled coagulopathy or blood disorders contraindicatingintramuscular 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 thetrial objectives.

  9. Subjects who have any history of confirmed or suspected immunosuppressive orimmunodeficient state, or received in the previous 4 weeks a treatment likely toalter the immune response (intravenous immunoglobulins, blood-derived products orlong-term corticosteroid therapy (> 2 weeks)).

  10. Subjects who have history of uncontrolled epilepsy or other progressive neurologicaldisorders, such as Guillain-Barre Syndrome.

  11. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month beforeand after IP immunization.

  12. Subjects plan to move from the study area before the end of study period.

Study Design

Total Participants: 696
Treatment Group(s): 2
Primary Treatment: SARS-CoV-2 subunit protein recombinant vaccine
Phase: 2
Study Start date:
September 01, 2022
Estimated Completion Date:
August 04, 2023

Study 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.

Connect with a study center

  • Faculty of Medicine Universitas Udayana

    Denpasar, Bali
    Indonesia

    Site Not Available

  • Faculty of Medicine Universitas Padjadjaran

    Bandung, West Java
    Indonesia

    Site Not Available

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