Safety and Immunogenicity of adenovirus vector COVID-19 vaccines following with additional dose of mRNA COVID-19 vaccines for cancer patients.
- Conditions
- COVID19 Vaccine efficacy in oncologic patient.viral vector vaccine , mRAN vaccinecancer patientsafety and immunogenicity
- Registration Number
- TCTR20220112004
- Lead Sponsor
- Quality Improvement fund, King chulalongkorn Memorial Hospital,The Thai Red Cross Society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
1)Patients age 18 years old and older
2)Diagnosed with cancer and is undergoing treatment at Chulalongkorn Hospital
3)ECOG Performance status 0-2
4)Has given consent to receiving COVID-19 vaccine
5)Has given consent to participate in the research study
1)Has histories of allergies (especially allergic reactions to vaccines)
2)Has histories of immune deficiency diseases (e.g. HIV or congenital immune deficiency)
3)Has been infected with COVID-19 within 14 days before receiving the vaccine
4)Has fever higher than 38c within 24 hours before receiving the vaccine
5)Received COVID-19 vaccine before
6)Has histories of hematologic diseases or has limitations for intramuscular injections
7)Has received immunosuppressant drugs unrelated to their cancer treatment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antibody response following the third mRNA COVID-19 vaccine in cancer patients 2 week and 12 week after third vaccine Geometric mean titer (GMT) of anti-RBD IgG
- Secondary Outcome Measures
Name Time Method Safety of third mRNA COVID-19 vaccine 7 days after third dose of mRNA vaccine FDA Toxicity grading scale in preventive vaccine clinical trials,Factors predicting poor immunogenicity 2 weeks after third dose multivariate analysis