COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20220318001

Kriangkrai Tawinprai

Kriangkrai.taw@cra.ac.th

2022-03-18

Not recruiting

nonRCT

Non-randomized

Parallel

Open label

multi-center

Prevention

1) healthy subjects aged 18 and above with full capacity for civil conduct and can provide information on vaccination of completing the 2 doses ChAdOx1 (AZD1222) vaccine or heterologous inactivated covid-19 vaccine/ChAdOx1 (AZD1222) vaccine for at least 3 months. 2) The subjects voluntarily participated in the study, signed informed consent, provided valid identity certificates, understood and complied with the requirements of the test protocol. 3) The subjects agreed to take effective contraceptive measures from the signing of informed consent to 1 month after the vaccination of the trial vaccine.

1. Confirmed cases of or asymptomatic COVID-19 infection or have a history of positive nucleic acid test of SARS-COV-2 2. Fever caused by any reason (such as cold, local inflammation, tumor, rheumatic immune disease, etc.) or armpit temperature 37.3 Celsius or more on the day of enrollment 3. Past severe allergic history to any vaccine, or active ingredients of the test vaccine, any inactive ingredients, and substances used in the production process, including aluminum preparations, such as acute allergic reaction, anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema. 4. History of respiratory tract infection within 14 days before enrollment. 5. Lactating women or pregnant women (including women with positive urine pregnancy test of childbearing age. 6. Uncontrolled comorbidity disease (adjust dose of the medication within 3 months). 7. Participants with malignancy comorbidity disease and currently received chemotherapy. 8. Currently received high dose steroid (20 mg per day of more of prednisolone or prednisolone equivalent) 9. Received immunosuppressive agents. 10. Age more than 60 years old. 11. Malnutrition status (Define as BMI less than 17 kg/m2)

2

Chulabhorn Royal Academy

18

60

Thailand

Healthy volunteers

N/A

200

Geometric mean concentration (GMC) of anti-RBD antibody after one dose of Recombinant Covid-19 Vaccine (CHO cells) as a booster following 2 doses of ChAdOx1 nCoV-19 (AZD1222) vaccine 4 weeks after booster dose Binding antibody assay

Phase 2/Phase 3

[{"arm_notes": " two doses of the ChAdOx1", "treatment_id": 1738, "treatment_name": "Zf2001", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": " CoronaVac +ChAdOx1", "treatment_id": 1738, "treatment_name": "Zf2001", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]