Kabat WB, Picard D, Read JS, Shin K, Watson S, Scott GB, Mitchell CD, Florez C, Jordan S, Belzer M, Flores N, Salata C, Tucker D, Douglas SD, Rutstein RM, Vincent CA, Coburn PC, Bettica L, Monti L, Johnson J, Dieudonne A, McMullen-Jackson C, Buschur S, Paul ME, Shearer WT, Jurgrau A, Silva G, Bonilla SV, Viani RM, Manning J, Stangl L, Darcey A, Swetnam J, Hassett MJ, Donnelly M, Giner J, Borkowsky W, Deygoo S, Akleh S, Kaul A, Zeichner S, Thompson D, Thomas C, Ganesan K, Melvin A, Frenkel L, Thomas J, Venema-Weiss C, Ferraro D, Infanzon E, Kelly M, Beneri C, Rongkavilit C, Moore E, Hancock U, Walters A, Rathore M, Mirza A, Maraqa N, Thoma K, McAuley JB, Boyer KM, McNichols M, Haerr P, Deveikis A, Chen T, Batra J, Michalik D, Utech J, Lott L, Discenza S, Patel N, Burchett S, Mao C, Kneut C, Karthas N, Keller MA, Hayes J, Gonzalez Y, Wettgen S, Homans J, Kovacs A, Spencer L, Neely M, Van Dyke RB, Alchediak T, Bradford SR, Turner OR.
Source
Pediatric, Adolescent, and Maternal AIDS Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA. siberryg@mail.nih.gov
Abstract
BACKGROUND:
Human immunodeficiency virus (HIV)-infected children are at increased risk of meningococcal infection and poor response to quadrivalent meningococcal conjugate vaccine (MCV4), but MCV4 has not been studied in preadolescent HIV-infected children.
METHODS:
The P1065 trial enrolled 2- to 10-year-old HIV-infected children with CD4 ≥ 25% to receive MCV4 at entry and at week 24. Rates of response (≥ 4-fold increase in rabbit serum bactericidal antibody) against each meningococcal serogroup (A, C, Y, W-135), geometric mean titers, and rates of seroprotection (rabbit serum bactericidal antibody titer ≥ 1:128) were determined from sera obtained at entry and weeks 4, 24, 28, and 72. Adverse events were assessed for 6 weeks after each MCV4 dose.
RESULTS:
At entry, 47% of the 59 participants were male, 56% black, 31% Latino, median age was 6 years, 88% were receiving antiretroviral therapy, and 75% had viral load <400 copies/mL. There were no serious adverse events within 6 weeks after MCV4 doses; all vaccination reactions were mild. Response after a single MCV4 dose was high to serogroup A (92%) and W-135 (98%); responses improved after a second dose for serogroup C (43%-80%) (P < 0.0001) and Y (76%-84%) (P = 0.38). By week 72, seroprotection rates were 93%, 91%, 78%, and 46% for serogroups W-135, Y, A, and C, respectively.
CONCLUSIONS:
Two doses of MCV4 were safe and immunogenic in 2- to 10-year-old HIV-infected children. The second dose increased the proportion of children who made a response to serogroup C. Seroprotection waned substantially for serogroups A and C within 1 year of last MCV4 dose.