Clincosm LogoSign in Get a demo

Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)

Sponsor
Advocate Health Care (Other)
Overall Status
Completed
CT.gov ID
NCT03061955
Collaborator
(none)
28
Enrollment
30.8
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and efficacy of concurrent administration of influenza vaccine in patients receiving anti-PD1 immunotherapy (nivolumab or pembrolizumab). This will be a prospective observational study, aiming to assess patient tolerance of treatment, adverse events (incidence, grade, need for hospitalization), incidence of influenza infections, and seroconversion rates.

Condition or Disease Intervention/Treatment Phase
  • Biological: influenza vaccination

Study Design

Study Type:
Observational
Actual Enrollment :
28 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
Actual Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Mar 31, 2017
Actual Study Completion Date :
Apr 26, 2019

Outcome Measures

Primary Outcome Measures

  1. Number of participants with confirmed influenza infection as assessed by influenza rapid antigen A and B testing, nose swab. [October 1st 2016 to March 31st 2017]

Secondary Outcome Measures

  1. Number of participants with adverse events and grading of adverse event as measured by the adverse events toxicity scale. [October 1st 2016 to March 31st 2017]

  2. Number of participants requiring hospitalizations for adverse events or influenza infection. [October 1st 2016 to March 31st 2017]

  3. Number of participants with seroconversion as assessed by influenza A and B IgM and IgG titers. [October 1st 2016 to March 31st 2017]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 18 years or older

  • Currently receiving immunotherapy with anti-PD-1 agents (Nivolumab or Pembrolizumab)

  • Have not received influenza vaccination prior to study entry date for the upcoming flu season 2016-2017

  • No previous contraindication to receiving influenza vaccination

  • Histologically proven cancer

  • Expected lifetime of at least 12 weeks

Exclusion Criteria:

  • Previous cancer

  • Autoimmune disease or immunosuppressive treatments

  • Corticosteroid treatment

  • Those who have a potential indication to change chemotherapy treatment in 42 days following start of treatment

  • History of clinically or virologically confirmed influenza infection in the previous six months

  • Previous contraindication to receiving influenza vaccination

  • Previous allergic/adverse reaction with influenza vaccination

  • Have received influenza vaccination prior to study entry date for upcoming 2016-2017 flu season

  • Positive anti influenza antibody titers as determined by the baseline blood determination (day 0)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Advocate Health Care

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sigrun Hallmeyer, MD, Hematologist Oncologist, Advocate Health Care
ClinicalTrials.gov Identifier:
NCT03061955
Other Study ID Numbers:
  • 6443
First Posted:
Feb 23, 2017
Last Update Posted:
Jul 10, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Influenza, Human

Study Results

No Results Posted as of Jul 10, 2019