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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest University Health Sciences
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Supportive care (vaccine therapy)
Patients receive trivalent influenza vaccine IM on day 0.
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Études corrélatives
Compte tenu de la messagerie instantanée
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 6 months
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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.
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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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
Délai: 6 months
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6 months
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Relationship between a variety of clinical factors and seroconversion following influenza vaccination
Délai: 6 months
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6 months
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Relationship between serologic markers of immune function and response to vaccination
Délai: 6 months
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6 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00018422
- NCI-2011-03033 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- CCCWFU 98411 (Autre identifiant: Wake Forest University Health Sciences)
Informations sur les médicaments et les dispositifs, documents d'étude
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