Cancer
Conditions
Keywords
influenza vaccine, cancer
Brief summary
The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.
Detailed description
The participants will be stratified by the age (cut off; 60 years old) and last year influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11 vaccination group. Day 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group will get the vaccine at Day 11, 10 days after chemotherapy begins. As the rate of completion of study in the Day 11 group is anticipated lower than Day 1 group, we will assign the participants into Day 1: Day 11 with the different ratio; 4:5. Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days after vaccination) will be examined in all participants. All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).
Interventions
BIOLOGICALDifferent timing of influenza vaccination
The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.
Sponsors
Green Cross Corporation
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of solid cancer. Specific definition of each term is like following: * The solid cancer includes various kinds of cancer except hematologic and lymphoid malignancies. * Cytotoxic chemotherapy includes adjuvant, neoadjuvant or palliative purpose of chemotherapy with the planned duration at least over 3 cycles every 3 weeks. * Targeted therapy drugs like as monoclonal antibody, tyrosine kinase inhibitor or oral chemotherapy drugs like as Xeloda are excluded. 2. Patients who did not receive the influenza vaccination yet in the current year. 3. Older than 19 years 4. Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2 5. Cell blood count meets following criteria: * Neutrophile count ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Hemoglobin ≥ 8 g/dL 6. Patients who can understand and agreed with the informed consents.
Exclusion criteria
1. Patients who have any contraindication for influenza vaccination. 2. Patients who are supposed to receive the last chemotherapy at the enrollment 3. Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy 4. Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect) 5. Patients with HIV and low CD 4+ T cell count (\< 500/uL) 6. Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine 7. Patients who have transplanted organ and receive immunosuppressants 8. Patients who are supposed to get prophylactic G-CSF after chemotherapy 9. Patients who are suspected to have active infectious disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection rate | 21-28 days after vaccination | The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion factor | 21-28 days after vaccination | Seroconversion factor is defined as mean fold increases in geometric mean titers of the haemagglutination inhibition(HI) after vaccination, expressed as a multiple. |
| Seroconversion rate | 21-28 days after vaccination | Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre |
| Geometric mean titre of HI | 21-28 days after vaccination | Geometric mean titers of HI (haemagglutination inhibition) after vaccination |
| Vaccine-related adverse events | within 28 days | the proportion of patients with any or serious vaccine-related adverse events |
Countries
South Korea
Outcome results
None listed