Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors
A Pilot Study of Influenza Vaccine Efficacy in Patients With Central Nervous System Tumors
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. The primary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in hemagglutinin inhibition (HI) titers from the pre-vaccination baseline.
SECONDARY OBJECTIVES:
I. A secondary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40.
II. The secondary objectives of this pilot study include an assessment of the relationship between a variety of clinical factors and seroconversion following influenza vaccination.
III. Subgroup analyses will include an investigation of seroconversion and treatment (actively receiving chemotherapy, radiation therapy or both), disease status (active treatment vs long term followup), and use and dose of glucocorticoids.
TERTIARY OBJECTIVES:
I. An additional area of interest which will be further explored in this pilot study is an assessment of the relationship between serologic markers of immune function and response to vaccination.
OUTLINE:
Patients receive trivalent influenza vaccine intramuscularly (IM) on day 0.
After completion of study treatment, patients are followed up at 14 days, 21 days, and 3 and/or 6 months.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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North Carolina
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest University Health Sciences
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients must have a clinical diagnosis of a primary central nervous system tumor
- Patients must be eligible to receive the influenza vaccine
- Patients must be able to provide written informed consent
Exclusion Criteria:
- Patients unable to receive the influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillan-Barré syndrome, or other contraindication to the vaccine
- Patients who have received the 2011-2012 annual influenza vaccine prior to being considered for enrollment on this study
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Supportive care (vaccine therapy)
Patients receive trivalent influenza vaccine IM on day 0.
|
Korrelativa studier
Givet IM
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in HI titers from the pre-vaccination baseline
Tidsram: 6 months
|
Seroconversion rate will be defined as the percentage of patients with at least a four-fold increase in HI antibodies between baseline and follow up.
Seroprotection rate will be defined as the percentage of patients with a serum HI antibody of at least 1:40.
The relationship between seroconversion and various clinical variables including therapy status (active vs longterm follow-up), glucorticoid dose and immune function will be measured.
Seroconversion and seroprotection rate comparisons will be made to publish normative data for the general population.
|
6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40
Tidsram: 6 months
|
6 months
|
|
Relationship between a variety of clinical factors and seroconversion following influenza vaccination
Tidsram: 6 months
|
6 months
|
|
Relationship between serologic markers of immune function and response to vaccination
Tidsram: 6 months
|
6 months
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00018422
- NCI-2011-03033 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- CCCWFU 98411 (Annan identifierare: Wake Forest University Health Sciences)
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