Vaccine effectiveness and safety of ZF2001 protein subunit vaccine as the heterologous booster dose COVID-19 vaccine, immunobridging study.

Vaccine effectiveness and safety of ZF2001 protein subunit vaccine as the heterologous booster dose COVID-19 vaccine, immunobridging study

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220318001

Enrollment

130

Registered

2022-03-18

Start date

2022-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine effectiveness of ZF2001 protein subunit vaccine as the third booster dose, immunobridging approach. Vaccine effectiveness, booster dose, protein subunit, immunobridging

Interventions

All subjects recruited shall have received two doses of the ChAdOx1 (AZD1222) vaccine for at least 3 months. All participants were received one dose of Recombinant COVID-19 Vaccine (CHO cells) (25 mcg

Active Comparator Drug,Active Comparator Drug

ZF2001 protein subunit vaccine in homologous AZD1222,ZF2001 protein subunit vaccine in heterologous CoronaVac/AZD1222

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
Solicited adverse events Within 7 days after vaccination. Questionnaire ,All adverse events Within 30 days after vaccination. Questionnaire	—

Countries

Thailand

Contacts

Public ContactKriangkrai Tawinprai

Chulabhorn Royal Academy

Kriangkrai.taw@cra.ac.th025766000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026