Safety of high dose trivalent inactivated influenza vaccine in pediatric patients
with acute lymphoblastic leukemia.
Author(s): McManus M(1), Frangoul H, McCullers JA, Wang L, O'Shea A, Halasa N.
Affiliation(s): Author information:
(1)Department of Pediatrics, Division of Hematology/BMT, University of Utah School
of Medicine/Primary Children's Hospital, Salt Lake City, Utah.
Publication date & source: 2014, Pediatr Blood Cancer. , 61(5):815-20
BACKGROUND: Although children with acute lymphoblastic leukemia (ALL) mount
immune responses after vaccination with the trivalent influenza vaccine (TIV),
these responses are lower compared to controls. Recently, a high dose (HD) TIV
was found to increase the level of antibody response in elderly patients compared
to the standard dose (SD) TIV. We hypothesized that the HD TIV would be
well-tolerated and more immunogenic compared to the SD TIV in pediatric subjects
with ALL.
PROCEDURE: This was a randomized, double-blind, phase I safety trial comparing
the HD to the SD TIV in children with ALL. Our secondary objective was
immunogenicity. Subjects were randomized 2:1 to receive either the HD (60 µg) or
the SD (15 µg) TIV. Local and systemic reactions were solicited, hemagglutinin
inhibition titers to influenza virus antigens were measured, and monitoring labs
were collected prior to and/or after each vaccination.
RESULTS: Fifty subjects were enrolled (34 HD, 16 SD). Mean age was 8.5 years; 63%
were male, and 80% were in maintenance therapy. There were no significant
differences reported in local or systemic symptoms. No severe adverse events were
attributed to vaccination. No significant differences between the HD and SD TIV
groups were noted for immune responses.
CONCLUSIONS: No differences were noted between the HD and SD TIV groups for
solicited systemic and local reactions. Since this study was not powered for
immunogenicity, a phase II trial is needed to determine the immunogenicity of HD
versus SD TIV in the pediatric ALL population.
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