Simple Summary There is limited information on the safety and efficacy of approved SARS-CoV-2 vaccines in cancer patients, as they were excluded from registration vaccine trials. We investigated the humoral immunity post SARS-CoV-2 vaccination in cancer patients compared to healthy volunteers. In this prospective cohort study, the seropositivity rate after two doses of vaccine was high in cancer patients despite active antineoplastic treatment, but their antibody titers were significantly lower than in healthy control subjects. Factors affecting immunogenicity in cancer patients, included older age, poor PS, active treatment, certain cancer types, i.e., pancreatic cancer and SCLC, male gender, and, interestingly, smoking status. Our results suggest that, given the lower immunogenicity, adjustments in vaccination strategies for more vulnerable subgroups of cancer patients may be required. Monitoring of antibody responses and elucidation of the clinical factors that influence immunity could guide future vaccination policies. Abstract Data on the effectiveness and safety of approved SARS-CoV-2 vaccines in cancer patients are limited. This observational, prospective cohort study investigated the humoral immune response to SARS-CoV-2 vaccination in 232 cancer patients from 12 HeCOG-affiliated oncology departments compared to 100 healthcare volunteers without known active cancer. The seropositivity rate was measured 2–4 weeks after two vaccine doses, by evaluating neutralising antibodies against the SARS-CoV-2 spike protein using a commercially available immunoassay. Seropositivity was defined as ≥33.8 Binding-Antibody-Units (BAU)/mL. A total of 189 patients and 99 controls were eligible for this analysis. Among patients, 171 (90.5%) were seropositive after two vaccine doses, compared to 98% of controls ( p = 0.015). Most seronegative patients were males (66.7%), >70-years-old (55.5%), with comorbidities (61.1%), and on active treatment (88.9%). The median antibody titers among patients were significantly lower than those of the controls (523 vs. 2050 BAU/mL; p < 0.001). The rate of protective titers was 54.5% in patients vs. 97% in controls ( p < 0.001). Seropositivity rates and IgG titers in controls did not differ for any studied factor. In cancer patients, higher antibody titers were observed in never-smokers ( p = 0.006), women ( p = 0.022), <50-year-olds ( p = 0.004), PS 0 ( p = 0.029), and in breast or ovarian vs. other cancers. Adverse events were comparable to registration trials. In this cohort study, although the seropositivity rate after two vaccine doses in cancer patients seemed satisfactory, their antibody titers were significantly lower than in controls. Monitoring of responses and further elucidation of the clinical factors that affect immunity could guide adaptations of vaccine strategies for vulnerable subgroups.
【저자키워드】 Antibody Response, SARS-CoV-2 vaccine, Anti-spike, cancer patient, neutralizing IgG, 【초록키워드】 Treatment, Efficacy, Vaccine, vaccination, vaccine doses, Immunity, Cancer, Comorbidity, Gender, prospective cohort study, Spike protein, cohort study, vaccine dose, immunoassay, Humoral immunity, cancers, neutralising antibody, response, healthcare, male, Patient, Older age, Antibody titer, Cancer patients, Effectiveness, Control, Seropositivity, monitoring, humoral immune response, women, information, smoking status, patients, seropositive, trials, SARS-CoV-2 vaccination, Protective, IgG titer, Analysis, dose, Vaccination strategy, subgroup, Factor, oncology, Adverse, healthy volunteers, healthy control, subgroups, active cancer, MOST, significantly lower, simple, ovarian, Volunteer, Pancreatic cancer, Affect, controls, event, was measured, defined, not differ, investigated, required, approved, median, subjects, comparable, affecting, clinical factor, eligible, seronegative patient, the SARS-CoV-2, were excluded, 【제목키워드】 SARS-CoV-2, response, Prospective, group, Cooperative,