Clinical trial NCT05525208: Booster Study of COVID-19 Protein Subunit Recombinant Vaccine
Official title: Observer-Blind, Randomized, Controlled Study of Immunogenicity and 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19 vaccine
healthy population
Booster
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Universitas Padjadjaran
name: Udayana University
First posted: 2022-09-01
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Clinically healthy adults 18 years of age and older.
2. 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.
3. Subjects have been informed properly regarding the study and signed the informed consent form.
4. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

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 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. 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 severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
7. History of uncontrolled coagulopathy or 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. 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)).
10. Subjects who have 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.

Primary outcomes:
measure: Immunogenicity of the candidate vaccine
timeFrame: 14 days after booster vaccination
Secondary outcomes:
measure: Seropositive rate of the candidate vaccine
timeFrame: Baseline, 14 days and 6 months after booster vaccination
measure: Seroconversion rate of the candidate vaccine
timeFrame: Baseline and 14 days after booster vaccination
measure: Seropositive rate and GMT of candidate vaccine
timeFrame: Baseline, 14 days, and 6 months after booster vaccination
measure: Seroconversion rate of the candidate vaccine
timeFrame: baseline and 14 days after booster vaccination
measure: Comparison of immunogenicity between candidate vaccine and control group
timeFrame: Baseline, 14 days, and 6 months after booster vaccination
measure: Safety of the candidate vaccine
timeFrame: 28 days after booster vaccination
measure: Serious Adverse Event (SAE) of the vaccine
timeFrame: 6 months after booster vaccination
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Faculty of Medicine Universitas Udayana
state: Bali
city: Bandung
country: Indonesia
facility: Faculty of Medicine Universitas Padjadjaran
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran
name: Kusnandi Rusmil, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: