NCT03061955
Completed
Not Applicable
Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Influenza Virus Vaccine Adverse Reaction (Disorder)
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 28
- Primary Endpoint
- Number of participants with confirmed influenza infection as assessed by influenza rapid antigen A and B testing, nose swab.
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
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
participants with confirmed influenza infection as assessed by influenza rapid antigen A and B testing, nose swab.
Secondary Outcomes
- 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)
- Number of participants requiring hospitalizations for adverse events or influenza infection.(October 1st 2016 to March 31st 2017)
- Number of participants with seroconversion as assessed by influenza A and B IgM and IgG titers.(October 1st 2016 to March 31st 2017)
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