MedPath

Safety and Immunological Response following homologous or heterologous booster COVID-19 vaccination (3rd dose study)

Phase 2
Completed
Conditions
healthy volunteers
healthcare workers
Registration Number
TCTR20210719006
Lead Sponsor
Faculty of Medicine Siriraj Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
360
Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Adverse events within 7 days after booster vaccine Proportion of Adverse events
Secondary Outcome Measures
NameTimeMethod
Immunological response including antibody level and cell mediated immune response 2 weeks and 16-20 weeks after vaccine IgG level, NT test, IGRA test
© Copyright 2025. All Rights Reserved by MedPath