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A Pilot Study: Safety and Immunological Response following Intradermal COVID-19 vaccination with Accelerate Regimen

A Pilot Study: Safety and Immunological Response following Intradermal COVID-19 vaccination with Accelerate Regimen

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210904004
Enrollment
60
Registered
2021-09-04
Start date
2021-09-11
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

Healthy volunteer COVID-19 vaccine safety immunological response intradermal Accelerate Regimen

Interventions

Sponsors

Health Systems Research Institute (HSRI)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Males or females at least 18-60 years of age (inclusive) 2. Have not received any COVID-19 vaccine? 3. Can understand Thai language through speaking, reading and writing? 4. Able to communicate through electronic tools such as Google form or line? 5. Capable of attending all study visits according to the study schedule. 6. Capable of informed consent and provision of written informed consent before any study procedures.

Exclusion criteria

Exclusion criteria: 1. Have history of severe drug or vaccine allergy (anaphylaxis)? 2. Have detected COVID-19 infection? 3. Have history of COVID-19 high risk contact? 4. Have history of Chronic respiratory disease, CVD, CKD, CVS, obesity, cancer and DM? 5. Positive result(s) from either antigen test kit. 6. Have received blood transfusion, plasma, blood product, blood component, immunoglobilins, antiviral or antibodies within the last 90 days? 7. Have history of cigarettes smoking, alcohol drinking and history of drug abuse? 8. Being pregnant? 9. have unstable disease or could not control the sysptom? 10. Have history of immunodeficiency or been using immunosuppressant or steriod drugs? 11. Have any unusual symptoms or medical history that considered unable to participate in the study?

Design outcomes

Primary

MeasureTime frame
Immunological Response 2 wk and 12 wk after complete vaccination IgG level

Secondary

MeasureTime frame
Safety 7 days after vaccination Adverse effects

Countries

Thailand

Contacts

Public ContactAssist. Prof. Suvimol Niyomnaitham

Faculty of Medicine Siriraj Hospital, Mahidol University

suvimol.niy@mahidol.edu0824542896

Outcome results

None listed

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