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

July 9, 2019 updated by: Sigrun Hallmeyer, MD, Advocate Health Care
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years or older or are receiving either nivolumab or pembrolizumab who have no yet received the influenza vaccine.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events and grading of adverse event as measured by the adverse events toxicity scale.
Time Frame: October 1st 2016 to March 31st 2017
October 1st 2016 to March 31st 2017
Number of participants requiring hospitalizations for adverse events or influenza infection.
Time Frame: October 1st 2016 to March 31st 2017
October 1st 2016 to March 31st 2017
Number of participants with seroconversion as assessed by influenza A and B IgM and IgG titers.
Time Frame: October 1st 2016 to March 31st 2017
October 1st 2016 to March 31st 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advocate Health Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

April 26, 2019

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on influenza vaccination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe