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

NCT03061955 | Completed

• 1 other identifier: 6443
• Study Type: observational
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza Virus Vaccine Adverse Reaction (Disorder); Influenza; Malignancy

Outcome Measures

Primary Outcomes (1)

• 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.

  October 1st 2016 to March 31st 2017

Secondary Outcomes (3)

• 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

Interventions

influenza vaccination BIOLOGICAL

administration of influenza vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Related Publications (9)

• Kunisaki KM, Janoff EN. Influenza in immunosuppressed populations: a review of infection frequency, morbidity, mortality, and vaccine responses. Lancet Infect Dis. 2009 Aug;9(8):493-504. doi: 10.1016/S1473-3099(09)70175-6.

  PMID: 19628174 BACKGROUND

• Mariotti J, Spina F, Carniti C, Anselmi G, Lucini D, Vendramin A, Pregliasco F, Corradini P. Long-term patterns of humoral and cellular response after vaccination against influenza A (H1N1) in patients with hematologic malignancies. Eur J Haematol. 2012 Aug;89(2):111-9. doi: 10.1111/j.1600-0609.2012.01793.x. Epub 2012 May 31.

  PMID: 22540245 BACKGROUND

• Pollyea DA, Brown JM, Horning SJ. Utility of influenza vaccination for oncology patients. J Clin Oncol. 2010 May 10;28(14):2481-90. doi: 10.1200/JCO.2009.26.6908. Epub 2010 Apr 12.

  PMID: 20385981 BACKGROUND

• Preventing Infections in Cancer Patients. 2015. (Accessed June 22, 2016, at https://www.cdc.gov/cancer/flu/.)

  BACKGROUND

• Rousseau B, Loulergue P, Mir O, Krivine A, Kotti S, Viel E, Simon T, de Gramont A, Goldwasser F, Launay O, Tournigand C. Immunogenicity and safety of the influenza A H1N1v 2009 vaccine in cancer patients treated with cytotoxic chemotherapy and/or targeted therapy: the VACANCE study. Ann Oncol. 2012 Feb;23(2):450-7. doi: 10.1093/annonc/mdr141. Epub 2011 May 16.

  PMID: 21576285 BACKGROUND

• Mulder SF, Jacobs JF, Olde Nordkamp MA, Galama JM, Desar IM, Torensma R, Teerenstra S, Mulders PF, Vissers KC, Punt CJ, de Vries IJ, van Herpen CM. Cancer patients treated with sunitinib or sorafenib have sufficient antibody and cellular immune responses to warrant influenza vaccination. Clin Cancer Res. 2011 Jul 1;17(13):4541-9. doi: 10.1158/1078-0432.CCR-11-0253. Epub 2011 Jun 28.

  PMID: 21712444 BACKGROUND

• Monkman K, Mahony J, Lazo-Langner A, Chin-Yee BH, Minuk LA. The pandemic H1N1 influenza vaccine results in low rates of seroconversion for patients with hematological malignancies. Leuk Lymphoma. 2011 Sep;52(9):1736-41. doi: 10.3109/10428194.2011.584003. Epub 2011 Jun 12.

  PMID: 21663502 BACKGROUND

• Yri OE, Torfoss D, Hungnes O, Tierens A, Waalen K, Nordoy T, Dudman S, Kilander A, Wader KF, Ostenstad B, Ekanger R, Meyer P, Kolstad A. Rituximab blocks protective serologic response to influenza A (H1N1) 2009 vaccination in lymphoma patients during or within 6 months after treatment. Blood. 2011 Dec 22;118(26):6769-71. doi: 10.1182/blood-2011-08-372649. Epub 2011 Nov 4.

  PMID: 22058114 BACKGROUND

• Weber JS, Hamid O, Chasalow SD, Wu DY, Parker SM, Galbraith S, Gnjatic S, Berman D. Ipilimumab increases activated T cells and enhances humoral immunity in patients with advanced melanoma. J Immunother. 2012 Jan;35(1):89-97. doi: 10.1097/CJI.0b013e31823aa41c.

  PMID: 22130166 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Neoplasms

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 23, 2017
• Study Start: October 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: April 26, 2019
• Last Updated: October 4, 2024

Record last verified: 2019-07