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.

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Key information

Conditions

Influenza Virus Vaccine Adverse Reaction (Disorder) Infections Influenza Influenza, Human Malignancy Neoplasms Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Influenza vaccination

Biological

administration of influenza vaccination

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.

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

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

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

participants requiring hospitalizations
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

participants with seroconversion

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2019
First posted: Feb 23, 2017
Registry last updated: Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed