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Influenza Vaccination in Cancer Patients

Primary Purpose

Cancer

Status

Terminated

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Different timing of influenza vaccination

About this trial

This is an interventional prevention trial for Cancer focused on measuring influenza vaccine, cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Patients who did not receive the influenza vaccination yet in the current year.
Older than 19 years
Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2
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
Patients who can understand and agreed with the informed consents.

Exclusion Criteria:

Patients who have any contraindication for influenza vaccination.
Patients who are supposed to receive the last chemotherapy at the enrollment
Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy
Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)
Patients with HIV and low CD 4+ T cell count (< 500/uL)
Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
Patients who have transplanted organ and receive immunosuppressants
Patients who are supposed to get prophylactic G-CSF after chemotherapy
Patients who are suspected to have active infectious disease.

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Day 1 vaccination

Day 11 vaccination

Arm Description

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.

Different timing of influenza vaccination: Day 11 Day 11 vaccination group: patients will be vaccinated against influenza at the 11th days after chemotherapy starts

Outcomes

Primary Outcome Measures

Seroprotection rate

The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)

Secondary Outcome Measures

Seroconversion factor

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

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

Geometric mean titers of HI (haemagglutination inhibition) after vaccination

Vaccine-related adverse events

the proportion of patients with any or serious vaccine-related adverse events

Full Information

NCT ID

NCT02213432

First Posted

August 7, 2014

Last Updated

February 22, 2016

Sponsor

Seoul National University Hospital

Collaborators

Green Cross Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02213432

Brief Title

Influenza Vaccination in Cancer Patients

Official Title

Randomized Controlled Trial to Compare Seroprotection Rate According to Timing of Influenza Vaccination in Adult Patients With Non-Hematologic Malignancies Receiving Scheduled Cytotoxic Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Why Stopped

Insufficient enrollment

Study Start Date

September 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Green Cross Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer

Keywords

influenza vaccine, cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Day 1 vaccination

Arm Type

Experimental

Arm Description

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.

Arm Title

Day 11 vaccination

Arm Type

Active Comparator

Arm Description

Different timing of influenza vaccination: Day 11 Day 11 vaccination group: patients will be vaccinated against influenza at the 11th days after chemotherapy starts

Intervention Type

Biological

Intervention Name(s)

Different timing of influenza vaccination

Intervention Description

The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.

Primary Outcome Measure Information:

Title

Seroprotection rate

Description

The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)

Time Frame

21-28 days after vaccination

Secondary Outcome Measure Information:

Title

Seroconversion factor

Description

Seroconversion factor is defined as mean fold increases in geometric mean titers of the haemagglutination inhibition(HI) after vaccination, expressed as a multiple.

Time Frame

21-28 days after vaccination

Title

Seroconversion rate

Description

Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre

Time Frame

21-28 days after vaccination

Title

Geometric mean titre of HI

Description

Geometric mean titers of HI (haemagglutination inhibition) after vaccination

Time Frame

21-28 days after vaccination

Title

Vaccine-related adverse events

Description

the proportion of patients with any or serious vaccine-related adverse events

Time Frame

within 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Patients who did not receive the influenza vaccination yet in the current year. Older than 19 years Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2 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 Patients who can understand and agreed with the informed consents. Exclusion Criteria: Patients who have any contraindication for influenza vaccination. Patients who are supposed to receive the last chemotherapy at the enrollment Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect) Patients with HIV and low CD 4+ T cell count (< 500/uL) Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine Patients who have transplanted organ and receive immunosuppressants Patients who are supposed to get prophylactic G-CSF after chemotherapy Patients who are suspected to have active infectious disease.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wan Beom Park, MD, PhD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Influenza Vaccination in Cancer Patients

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