title: Randomized, double-blind comparison of standard-dose vs. high-dose trivalent inactivated influenza vaccine in pediatric solid organ transplant patients.
abstract: Children who have undergone SOT mount a lower immune response after vaccination with TIV compared to healthy controls. HD or SD TIV in pediatric SOT was given to subjects 3-17 yr and at least six months post-transplant. Subjects were randomized 2:1 to receive either the HD (60 μg) or the SD (15 μg) TIV. Local and systemic reactions were solicited after each vaccination, and immune responses were measured before and after each vaccination. Thirty-eight subjects were enrolled. Mean age was 11.25 yr; 68% male, 45% renal, 26% heart, 21% liver, 5% lung, and 5% intestinal. Twenty-three subjects were given HD and 15 SD TIV. The median time since transplant receipt was 2.2 yr. No severe AEs or rejection was attributed to vaccination. The HD group reported more tenderness and local reactions, fatigue, and body ache when compared to the SD cohort, but these were considered mild and resolved within three days. Subjects in the HD group demonstrated a higher percentage of four-fold titer rise to H3N2 compared to the SD group. HD influenza vaccine was well tolerated and may have increased immunogenicity. A phase 2 trial is needed to confirm.
authors.affiliation: Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: GiaQuinta
authors.forename: Marian G
authors.initials: MG
authors.lastname: Michaels
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: McCullers
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.forename: Christopher
authors.initials: C
authors.lastname: Fonnesbeck
authors.forename: Alice
authors.initials: A
authors.lastname: O'Shea
authors.forename: Michael
authors.initials: M
authors.lastname: Green
authors.forename: Natasha B
authors.initials: NB
authors.lastname: Halasa
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053122:Influenza A Virus, H3N2 Subtype; D007252:Influenza Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D016377:Organ Transplantation; D061214:Patient Safety; D011446:Prospective Studies; D018401:Sample Size; D066027:Transplant Recipients; D016896:Treatment Outcome; D014611:Vaccination / Q000009:adverse effects
chemical_list: D007252:Influenza Vaccines
keywords: influenza; solid organ transplant; vaccine