COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20210719006

Nasikarn Angkasekwinai

nasikarn.ang@mahidol.ac.th

2021-07-19

Not recruiting

nonRCT

Non-randomized

Sequential assignment

Open label

single-center

Prevention

- Males or females at least 18 years of age (inclusive) - Have received 2nd dose of COVID-19 vaccine (CoronaVac or ChAdOx1) for 8-12 weeks earlier - Can understand Thai language through speaking, reading and writing - Able to communicate through electronic tools such as Google form or line - Capable of attending all study visits according to the study schedule - Capable of informed consent and provision of written informed consent before any study procedures

- Have history of severe drug or vaccine allergy (anaphylaxis) - Have detected COVID-19 infection within the last 90 days - Have received blood transfusion, plasma, blood product, blood components, immunoglobulins, antiviral or antibodies within the last 90 days - Have history of cigarettes smoking, alcohol drinking and history of drug abuse - Be pregnant - Have unstable disease or could not control the symptom - Have history of immunodeficiency or use immunosuppressant or steroid drugs - Have any unusual symptoms or medical history that considered unable to participate in the study

10

Faculty of Medicine Siriraj Hospital

18

100

Thailand

Healthy volunteers

N/A

360

Adverse events within 7 days after booster vaccine Proportion of Adverse events

Phase 2

[{"arm_notes": "Booster with BBIBP-CorV after 2 dose of CoronaVac", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster with 30 mcg BNT162b2 after 2 dose of CoronaVac", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster with BBIBP-CorV after 2 dose of ChAdOx1", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster with 15 mcg BNT162b2 after 2 dose of CoronaVac", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster with 30 mcg BNT162b2 after 2 dose of ChAdOx1", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\nBooster with ChAdOx1 after 2 dose of CoronaVac", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster with ChAdOx1 after 2 dose of ChAdOx1", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster with 15 mcg BNT162b2 after 2 dose of ChAdOx1", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]