Influenza Virus Vaccine Adverse Reaction (Disorder)NCT03061955
Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
An observational study of Influenza Virus Vaccine Adverse Reaction (Disorder) and Influenza, run by Wake Forest University Health Sciences.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza Virus Vaccine Adverse Reaction (Disorder), Influenza, Malignancy
- What is being tested?
- influenza vaccination
- Type of treatment
- Vaccines
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 26 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years or older or are receiving either nivolumab or pembrolizumab who have no yet received the influenza vaccine.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
About this study
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.
- Being tested
- influenza vaccination
- Medical subject headings
- Influenza, Human, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza vaccinationBiological
administration of influenza vaccination
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
participants with adverse events
Measured: October 1st 2016 to March 31st 2017
Number of participants requiring hospitalizations for adverse events or influenza infection.
participants requiring hospitalizations
Measured: October 1st 2016 to March 31st 2017
Number of participants with seroconversion as assessed by influenza A and B IgM and IgG titers.
participants with seroconversion
Measured: October 1st 2016 to March 31st 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Oct 2016
- Primary completion31 Mar 2017
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Influenza Virus Vaccine Adverse Reaction (Disorder)Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061955
- Sponsor's protocol ID
- 6443
- Status last verified
- Jul 2019
- First submitted
- 9 Feb 2017
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19628174Mariotti 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.
PubMed 22540245Pollyea 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.
PubMed 20385981Preventing 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.
PubMed 21576285Mulder 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.
PubMed 21712444Monkman 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.
PubMed 21663502Yri 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.
PubMed 22058114Weber 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.
PubMed 22130166
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
- ClinicalTrials.gov ID
- NCT03061955
- Acronym / sponsor ID
- 6443
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or older or are receiving either nivolumab or pembrolizumab who have no yet received the influenza vaccine.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| influenza vaccinationadministration of influenza vaccination | Biological | – |
Primary outcome
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.
3 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
Number of participants requiring hospitalizations for adverse events or influenza infection.
Time frame: October 1st 2016 to March 31st 2017
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 19628174Kunisaki 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.
- Background: PubMed 22540245Mariotti 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.
- Background: PubMed 20385981Pollyea 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.
- BackgroundPreventing Infections in Cancer Patients. 2015. (Accessed June 22, 2016, at https://www.cdc.gov/cancer/flu/.)
- Background: PubMed 21576285Rousseau 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.
- Background: PubMed 21712444Mulder 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.
- Background: PubMed 21663502Monkman 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.
- Background: PubMed 22058114Yri 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.
- Background: PubMed 22130166Weber 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Virus Vaccine Adverse Reaction (Disorder) and Influenza, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061955, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.