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

N/ACompletedNCT03061955

Wake Forest University Health Sciences28 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Influenza Virus Vaccine Adverse Reaction (Disorder)Influenza Malignancy

Interventions

influenza vaccinationBIOLOGICAL

administration of influenza vaccination

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Number of participants with confirmed influenza infection as assessed by influenza rapid antigen A and B testing, nose swab.

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

Secondary Outcomes

Number of participants with adverse events and grading of adverse event as measured by the adverse events toxicity scale.

participants with adverse events

Time frame: October 1st 2016 to March 31st 2017

Number of participants requiring hospitalizations for adverse events or influenza infection.

participants requiring hospitalizations

Time frame: October 1st 2016 to March 31st 2017

Number of participants with seroconversion as assessed by influenza A and B IgM and IgG titers.

participants with seroconversion

Time frame: October 1st 2016 to March 31st 2017