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Influenza Vaccination in Cancer Patients

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ClinicalTrials.gov Identifier: NCT02213432
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : August 11, 2014
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
Green Cross Corporation
Information provided by (Responsible Party):
Wan Beom Park, 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.

Condition or disease Intervention/treatment Phase
Cancer Biological: Different timing of influenza vaccination Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : September 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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.




Primary Outcome Measures :
  1. Seroprotection rate [ Time Frame: 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 :
  1. Seroconversion factor [ Time Frame: 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.

  2. Seroconversion rate [ Time Frame: 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

  3. Geometric mean titre of HI [ Time Frame: 21-28 days after vaccination ]
    Geometric mean titers of HI (haemagglutination inhibition) after vaccination

  4. Vaccine-related adverse events [ Time Frame: within 28 days ]
    the proportion of patients with any or serious vaccine-related adverse events



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213432


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Green Cross Corporation
Investigators
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Principal Investigator: Wan Beom Park, MD, PhD Seoul National University Hospital

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Responsible Party: Wan Beom Park, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02213432     History of Changes
Other Study ID Numbers: 1407-057-593
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Keywords provided by Wan Beom Park, Seoul National University Hospital:
influenza vaccine
cancer
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs