Immunological Responses and safety after COVID-19 vaccination in Healthcare Workers at Siriraj Hospital, Bangkok

Phase 2

Completed

• Conditions: healthy volunteers; healthcare Workers

• Registration Number: TCTR20210720002
• Lead Sponsor: Faculty of Medicine Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-20
• Study Completion: 2021-08-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Males or females at least 18 years of age (inclusive)
2. Be subject of study Seroprevalence, Incidence and Immunological Responses to SARS-CoV-2 Infection among Frontline Healthcare Workers compare with Non-COVID-19 HCWs during the COVID-19 Pandemic at Siriraj Hospital, Bangkok or healthcare workers who interested in receiving the vaccine in the study
3. Capable of informed consent and provision of written informed consent before any study procedures

Exclusion Criteria

1. Could not receive vaccine such as history of anaphylaxis or severe infection with high temperature (over 38C)
2. Have received blood transfusion, plasma, blood product, blood components, immunoglobulins, antiviral or antibodies for treatment of COVID-19 within the last 90 days
- Have detected COVID-19 infection within the last 10 days
3. Have unstable disease or could not control the symptom such as chest pain, dyspnea, palpitation, etc.
4. Be pregnant
5. Have history of immunodeficiency or use immunosuppressant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events 48 week Proportion of participant with adverse events within 7 days after vaccination

Secondary Outcome Measures

Name	Time	Method
evel of antibody response 48 week IgG level