Improved immunogenicity of XXXX compared to standard-dose influenza vaccine in adult oncology @entity1 younger than 65 years receiving chemotherapy: A pilot randomized clinical trial.

@entity1 @entity168 @entity683 @entity2033
PURPOSE: @entity1 undergoing chemotherapy often fail to develop robust responses to influenza vaccination. Compared to standard-dose influenza vaccine ( @entity168 ), @entity683 ( @entity2033 ) has shown improved immunogenicity and protection against @entity683 in adults 65 years and older. This study compared the immunogenicity and tolerability of @entity2033 to @entity168 in adults younger than 65 years of age receiving chemotherapy. METHODS: This double-blind study randomized @entity1 receiving chemotherapy to vaccination with either @entity168 or @entity2033 influenza vaccine. Hemagglutination inhibition assays (HAI) were performed prior to and 4 weeks after vaccination. HAI were summarized as geometric mean titers (GMT), seroconversion rates, and seroprotection rates. RESULTS: A total of 105 subjects were enrolled in the trial (51 received @entity168 and 54 received @entity2033 ). Subjects were well matched for demographic and medical conditions. Both vaccines were well tolerated with no SAEs. Of the 100 subjects with evaluable data, seroconversion rates for all 3 influenza antigens _ post-vaccination GMTs for H3N2 _ B strains were significantly improved with @entity2033 compared to @entity168 . Seroprotection was excellent and equivalent in both groups. CONCLUSIONS: Trivalent @entity683 can be safely administered to @entity1 receiving chemotherapy with improved immunogenicity and seroconversion compared to standard-dose vaccine. Post-vaccination seroprotection rates were similar in both groups. A larger study is needed to show clinical benefits with @entity2033 in this population. This study was registered at ClinicalTrials.gov as NCT01666782.
