Immunogenicity and Safety Study of Half and Full Dose of Heterologous and Homologous COVID-19 Vaccine Booster in Adult Subjects in Indonesia

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Fakultas Kedokteran Universitas Padjajaran, Bandung dan Fakultas Kedokteran Universitas Indonesia, Jakarta
No Registry
INA-GO0HLGB
Tanggal Input Registry : 25-11-2021

26-11-2021
To evaluate the antibody titres before and one month (+7 days) after booster dose with full and half booster dose of ChAdOx1-S, Comirnaty®, or CoronaVac®.
1. To evaluate the rate and severity of the reactogenicity within 24h, one week and one month of each booster vaccine group 2. To compare the immune responses between full and half booster doses of each vaccine studied.
 
Immunogenicity and Safety Study of Half and Full Dose of Heterologous and Homologous COVID-19 Vaccine Booster in Adult Subjects in Indonesia
Immunogenicity and Safety Study of Half and Full Dose of Heterologous and Homologous COVID-19 Vaccine Booster in Adult Subjects in Indonesia
Eksperimental
• Comirnaty® (Pfizer Vaccine) 0.3 ml intramuscularly • Comirnaty® (Pfizer Vaccine) 0.15 ml intramuscularly • ChAdOx1-S (AstraZeneca Vaccine) 0.5 ml intramuscularly • ChAdOx1-S (AstraZeneca Vaccine) 0.25 ml intramuscularly • CoronaVac® (Sinovac Vaccine) 0.5 ml intramuscularly
1500
 

Inclusion Criteria:

1. Clinically healthy adults aged above 18 years who had completed the primary series of SARS-CoV-2 vaccine with CoronaVac® within 3 to

Exclusion Criteria:

1. Those who have already received a third dose of SARS-CoV-2 vaccine 2. Concomitantly enrolled or scheduled to be enrolled in another trial. 3. Those with fever (temperature ˃ 37.5℃, measured with infrared thermometer/thermal gun), upper respiratory tract infection symptoms such as sneezing, nasal congestion, runny nose, cough, sore throat, loss of taste chills and shortness of breath within 72 hours before enrolment. 4. Blood pressure ˃ 180/110 mmHg. 5. History of laboratory confirmed COVID-19 within one month prior to study enrolment. 6. History of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 7. Those with uncontrolled autoimmune disease such as lupus 8. History of uncontrolled coagulopathy or blood disorders, immune deficiency, and received blood derived product/transfusion within 3 months prior to enrolment. 9. Those who received immunosuppressant therapy such as corticosteroid and cancer chemotherapy 10. Those with uncontrolled chronic disease, such as severe heart disease, asthma exacerbation 11. Subjects who have history of uncontrolled epilepsy (within the last 2 years) or other progressive neurological disorders, such as Guillain-Barre Syndrome 12. Those who receive any vaccination within 1 month before and after booster with study vaccine. 13. Pregnant woman with ≤13 weeks of pregnancy or pregnancy with sign of preeclampsia (swollen legs, headache, heartburn, blurred vision, blood pressure > 140/90 mmHg). 14. Those aged ≥60 years old with difficulty in climbing 10 steps of stairs, frequently experiencing fatigue, difficulty in walking 100–200 m, or having at least 5 comorbidities (hypertension, diabetes, cancer, chronic lung disease, heart attack, congestive heart failure, chest pain, asthma, joint pain, stroke, and kidney disease).
 
KEPK Balitbangkes, LB.02.01/2/KE.693/2021
Tidak Berlaku
RG.01.06.1.3.11.21.61
UK COVID Balitbangkes 010
Dr. Eddy Fadlyana, dr., Sp.A(K)., MKes