Safety and humoral immunogenicity of COVID-19 vaccine against SAR-CoV2 wild type and Omicron variant in patients with solid cancer

Completed

• Conditions: Solid cancerCOVID-19; Carcinoma; Sarcoma; COVID-19 Vaccines

• Registration Number: TCTR20230510001
• Lead Sponsor: Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-01-04
• Study Start: 2023-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. age 18 years or above
2. Has an appointment to receive vaccine against SAR-CoV2
3. Confirmed diagnosis of solid tumor by pathology or imaging with any stages, treatments and responses after treatment that include complete remission disease within 1 year
4. Life expectancy is more than 6 months at the time receiving first dose of vaccine

Exclusion Criteria

1. Previously diagnosed COVID-19 in the past 90 days
2. High-risk epidemiology history within 14 days before enrolment e.g. close contact with index cases or visiting/ living in outbreak area
3. Receive blood products, blood components, or immunoglobulin within the past 90 days
4. Receive live attenuated vaccine in the past 28 days
5. Receive inactivated or subunit vaccines in the past 14 days
6. Women in lactation, pregnancy, or planned pregnancy during the study period
7. Known allergy to any vaccine component
8. Has signs and symptoms of active skin infection at injection site
9.Known history of HIV infection
10.Receive immunosuppressive drug
11. Has uncontrolled medical illness that include cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological disease

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seroconversion rate of neutralizing antibody 28 days after second dose of vaccine percent inhibition of neutralizing antibody

Secondary Outcome Measures

Name	Time	Method
Seroconversion rate of neutralizing antibody 6 months after second dose of vaccine percent inhibition of neutralizing antibody,safety outcome 28 days after second dose of vaccine patients reported outcome using questionnaire interview about adverse events