Immunogenicity and safety of the third dose COVID-19 vaccine via intradermal compare with intramuscular administration (Randomized controlled trial)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210731003

Enrollment

960

Registered

2021-07-31

Start date

2021-08-09

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

The immune response after the third dose of the COVID-19 vaccine via intradermal administration in healthy volunteers. COVID-19 vaccine, Third dose, intradermal, ChAdOx1, coronavac, Sinovac, BNT162b2, mRNA1263, Sinopharm

Interventions

Administration of 0.5 ml of BBIBP-CorV intramuscular for 1 dose ,Administration of 0.5 ml of BBIBP-CorV intradermal for 1 dose ,Administration of 0.5 ml of BBIBP-CorV intradermal for 2 doses ,Admin

Active Comparator Biological/Vaccine,Active Comparator Biological/Vaccine,Active Comparator Biological/Vaccine,Active Comparator Biological/Vaccine,Active Comparator Biological/Vaccine,Active Comparat

CoronaVac/BBIBP-CorV_IM,CoronaVac/BBIBP-CorV_ID1,CoronaVac/BBIBP-CorV_ID2,CoronaVac/AZD1222_IM,CoronaVac/AZD1222_ID1,CoronaVac/AZD1222_ID2,CoronaVac/BNT162b2_IM,CoronaVac/BNT162b2_ID1,CoronaVac/BNT162

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. 18 years old or more 2. No history of a severe allergic reaction to the prior vaccine. 3. No fever nor history of fever within 14 days. 4. No symptoms of respiratory tract infection within 14 days. 5. Received two doses of COVID-19 vaccine for at least 3 months 6. sign informed consent to the study.

Exclusion criteria

Exclusion criteria: 1. pregnancy. 2. lactation.

Design outcomes

Primary

Measure	Time frame
Humoral immunity 2 weeks after third dose 2 weeks after the third dose of the vaccine Double antigen technique for detection of Antibody level of total antibody of spike protein of SARS-CoV-2	—

Secondary

Measure	Time frame
Safety profile after vaccination in each intervention arms 1 weeks after the third dose of the vaccine Solicited and non-solicited adverse events,Humoral immunity 2 weeks after third dose 1 weeks after the third dose of the vaccine Surrogate Neutralizing antibody ,Humoral immunity 2 weeks after third dose 2 weeks after the third dose of the vaccine Neutralizing antibody,Cell mediated respons 2 weeks after the third dose of the vaccine Interferon gamma releasing assay	—

Measure

Time frame

Safety profile after vaccination in each intervention arms 1 weeks after the third dose of the vaccine Solicited and non-solicited adverse events,Humoral immunity 2 weeks after third dose 1 weeks after the third dose of the vaccine Surrogate Neutralizing antibody ,Humoral immunity 2 weeks after third dose 2 weeks after the third dose of the vaccine Neutralizing antibody,Cell mediated respons 2 weeks after the third dose of the vaccine Interferon gamma releasing assay

—

Countries

Thailand

Contacts

Public ContactKriangkrai Tawinprai

HRH Princess Chulabhorn College of Medical Science

Kriangkrai.taw@pccms.ac.th0815748167

Outcome results

None listed

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