Research for COVID-19 vaccine among lung cancer patients undergoing chemotherapy

JRCT ID: jRCT1071210024

Registered date:18/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 12/05/2021
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: immunogenicity
• Secondary Outcome: effectiveness, side efects after vaccination, vaccine associated adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Any of the following a or b
a Patients with lung cancer on chemotherapy over 50 years
b Patients with underlying disease (except for cancer) over 50 years old
2) Those who are visiting a medical institution conducting research (Kameda Medical Center, Chikamori hospital)
3) Subjects who voluntarily recieve the COVID-19 vaccine
4) Written informed consent

Exclude criteria

1) Those who have the contraindications for vaccination
2) Those who have been vaccinated with the new coronavirus vaccine in the past
(Including participation in clinical trials or clinical trials / research)
3) Those who are receiving systemic steroids / immunosuppressants (excluding administration of anticancer drugs as antiemetics)
4) Persons with autoimmune disease under treatment
5) Those who have experienced an acute illness that requires antibiotics or steroids within the past one month
6) Those who have a fever at the time of vaccination, those who present with acute serious illness
7) Persons who are judged by the principal investigator or the investigator to be inappropriate as research subjects

Related Information

• Primary Sponsor: Nakashima Kei
• Secondary Sponsor: Hirota Yoshio