Clinical trial NCT03061955: Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
Official title: Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Virus Vaccine Adverse Reaction (Disorder)
Influenza
Malignancy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with confirmed influenza infection as assessed by influenza rapid antigen A and B testing, nose swab.
timeFrame: October 1st 2016 to March 31st 2017
Secondary outcomes:
measure: Number of participants with adverse events and grading of adverse event as measured by the adverse events toxicity scale.
timeFrame: October 1st 2016 to March 31st 2017
measure: Number of participants requiring hospitalizations for adverse events or influenza infection.
timeFrame: October 1st 2016 to March 31st 2017
measure: Number of participants with seroconversion as assessed by influenza A and B IgM and IgG titers.
timeFrame: October 1st 2016 to March 31st 2017
Other outcomes:
Locations:
Study officials:
References:
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