Influenza Vaccination in Cancer Patients

Not Applicable

Terminated

• Conditions: Cancer
• Interventions: Biological: Different timing of influenza vaccination

• Registration Number: NCT02213432
• Lead Sponsor: Seoul National University Hospital

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).

Study Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-11
• Study Start: 2014-09
• Primary Completion: 2015-02
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 97

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Day 11 vaccination	Different timing of influenza vaccination	Different timing of influenza vaccination: Day 11 Day 11 vaccination group: patients will be vaccinated against influenza at the 11th days after chemotherapy starts
Day 1 vaccination	Different timing of influenza vaccination	Different timing of influenza vaccination: Day 1 Day 1 vaccination group: patients will be vaccinated against influenza at the day (Day 1) when chemotherapy starts.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Geometric mean titre of HI	21-28 days after vaccination	Geometric mean titers of HI (haemagglutination inhibition) after vaccination
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
Vaccine-related adverse events	within 28 days	the proportion of patients with any or serious vaccine-related adverse events

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of