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Preliminary study: Safety and Immunological Response following COVID-19 Vaccination in COVID-19 survivors

Phase 2
Recruiting
Conditions
COVID-19 survivors
COVID-19 Vaccination
Registration Number
TCTR20210720005
Lead Sponsor
Faculty of Medicine Siriraj Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
180
Inclusion Criteria

1. Males or females at least 18 years of age (inclusive)
2. Had a history of SARS-CoV-2-positive by RT-PCR from airway specimens at screening day (10+/-4 weeks or 20+/-4 weeks after detection)
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

1. Have history of severe drug or vaccine allergy (anaphylaxis)
2. Have received blood transfusion, plasma, blood product, blood components, immunoglobulins, antiviral or antibodies within the last 90 days
3. Have history of cigarettes smoking, alcohol drinking and history of drug abuse
4. Be pregnant
5. Have history of any vaccination within 14 days before screening visit
6. Had received more than one COVID-19 vaccination before diagnosis of COVID-19 infection
7.Had received any COVID-19 vaccination after Yes
diagnosis of COVID-19 infection
8. Have unstable disease or could not control the symptom
9.Have history of immunodeficiency or use immunosuppressant or steroid drugs?
10. 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 4 weeks amount of adverse events
Secondary Outcome Measures
NameTimeMethod
Immune response 24 weeks Immune response level
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