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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03061955
• Other study ID #: 6443
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: April 26, 2019

Study information

• Verified date: July 2019
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 26, 2019
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Influenza
• Influenza Virus Vaccine Adverse Reaction (Disorder)
• Influenza, Human
• Malignancy

Intervention

Biological:
• influenza vaccination
administration of influenza vaccination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Yri OE, Torfoss D, Hungnes O, Tierens A, Waalen K, Nordøy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of 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	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
Secondary	Number of participants requiring hospitalizations for adverse events or influenza infection.		October 1st 2016 to March 31st 2017
Secondary	Number of participants with seroconversion as assessed by influenza A and B IgM and IgG titers.		October 1st 2016 to March 31st 2017