ABSTRACT
This study assessed the immunogenicity and safety of the BNT162b2 mRNA vaccine in lung cancer patients receiving anticancer treatment. We enrolled lung cancer patients receiving anticancer treatment and non-cancer patients; all participants were fully vaccinated with the BNT162b2 vaccine. Blood samples were collected before the first and second vaccinations and 4 ± 1 weeks after the second vaccination. Anti-severe respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein S1 subunit receptor-binding domain antibody titers were measured using the Architect SARS-CoV-2 IgG II Quant and Elecsys Anti-SARS-CoV-2 S assays. Fifty-five lung cancer patients and 38 non-cancer patients were included in the immunogenicity analysis. Lung cancer patients showed significant increase in the geometric mean antibody concentration, which was significantly lower than that in the non-cancer patients after the first (30 vs. 121 AU/mL, p < .001 on Architect; 4.0 vs 1.2 U/mL, p < .001 on Elecsys) and second vaccinations (1632 vs. 3472 AU/mL, p = .005 on Architect; 213 vs 573 A/mL, p = .002 on Elecsys). The adjusted odds ratio (aOR) for seroprotection was significantly lower (p < .05) in lung cancer patients than that in non-cancer patients. Analysis of the anticancer treatment types showed that the aOR for seroprotection was significantly lower (p < .05) in lung cancer patients receiving cytotoxic agents. They showed no increase in adverse reactions. BNT162b2 vaccination in lung cancer patients undergoing anticancer treatment significantly increased (p < .05) antibody titers and showed acceptable safety. Immunogenicity in these patients could be inadequate compared with that in non-cancer patients.
ABSTRACT
Condition:
COVID-19Primary outcome:
immunogenicityCriteria:
Inclusion criteria: 1) Any of the following a or ba 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
Exclusion 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