Premium
Randomized, double‐blind comparison of standard‐dose vs. high‐dose trivalent inactivated influenza vaccine in pediatric solid organ transplant patients
Author(s) -
GiaQuinta Sarah,
Michaels Marian G.,
McCullers Jonathan A.,
Wang Li,
Fonnesbeck Christopher,
O'Shea Alice,
Green Michael,
Halasa Natasha B.
Publication year - 2015
Publication title -
pediatric transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.457
H-Index - 69
eISSN - 1399-3046
pISSN - 1397-3142
DOI - 10.1111/petr.12419
Subject(s) - medicine , vaccination , immunogenicity , gastroenterology , randomization , titer , randomized controlled trial , influenza vaccine , cohort , surgery , immunology , immune system , antibody
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 AE s 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.