Influenza Vaccination in Cancer Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Biological: Different timing of influenza vaccination

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Day 1 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.	Biological: Different timing of influenza vaccination; The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.
Active Comparator: Day 11 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	Biological: Different timing of influenza vaccination; The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprotection rate	The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)	21-28 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21-28 days after vaccination
Seroconversion rate	Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre	21-28 days after vaccination
Geometric mean titre of HI	Geometric mean titers of HI (haemagglutination inhibition) after vaccination	21-28 days after vaccination
Vaccine-related adverse events	the proportion of patients with any or serious vaccine-related adverse events	within 28 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Green Cross Corporation
• Investigators: Principal Investigator: Wan Beom Park, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimate): August 11, 2014

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: cancer; influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 1407-057-593