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

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

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.

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)