Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
NCT ID: NCT03061955
Last Updated: 2024-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
28 participants
OBSERVATIONAL
2016-10-01
2019-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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influenza vaccination
administration of influenza vaccination
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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References
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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.
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.
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.
Preventing Infections in Cancer Patients. 2015. (Accessed June 22, 2016, at https://www.cdc.gov/cancer/flu/.)
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.
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.
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.
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.
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.
Other Identifiers
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6443
Identifier Type: -
Identifier Source: org_study_id
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