BACKGROUND:Otitis media with effusion (OME) is very common during childhood. Because Streptococcus pneumoniae is one of the most common bacterial pathogens involved in OME, pneumococcal vaccines may have a role in the prevention of recurrent OME. OBJECTIVE: We sought to assess the effect of combined pneumococcal conjugate and polysaccharide vaccinations on the recurrence of OME. METHODS: A randomized, controlled trial was performed with 161 children, 2 to 8 years of age, with documented persistent bilateral OME. All subjects were treated with tympanostomy tubes (TTs). One half of the subjects were assigned randomly to additional vaccination with a 7-valent pneumococcal conjugate vaccine 3 to 4 weeks before and a 23-valent pneumococcal polysaccharide vaccine 3 months after tube insertion. Blood samples were drawn at the first vaccination, at the time of TT placement, and 1 and 3 months after the second vaccination. Levels of IgA and IgG serum antibody against the 7-valent pneumococcal conjugate vaccine serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F were measured with enzyme-linked immunosorbent assays. All children were monitored for recurrence of OME for 6 months after spontaneous extrusion of the TTs. RESULTS: The overall recurrence rate of bilateral OME was 50%. Pneumococcal vaccinations induced significant 4.6- to 24.4-fold increases in the geometric means of all conjugate vaccine serotype antibody titers but did not affect recurrence of OME. CONCLUSIONS:Combined pneumococcal conjugate and polysaccharide vaccination does not prevent recurrence of OME among children 2 to 8 years of age previously known to have persistent OME. Therefore, pneumococcal vaccines are not indicated for the treatment of children suffering from recurrent OME.
RCT Entities:
BACKGROUND:Otitis media with effusion (OME) is very common during childhood. Because Streptococcus pneumoniae is one of the most common bacterial pathogens involved in OME, pneumococcal vaccines may have a role in the prevention of recurrent OME. OBJECTIVE: We sought to assess the effect of combined pneumococcal conjugate and polysaccharide vaccinations on the recurrence of OME. METHODS: A randomized, controlled trial was performed with 161 children, 2 to 8 years of age, with documented persistent bilateral OME. All subjects were treated with tympanostomy tubes (TTs). One half of the subjects were assigned randomly to additional vaccination with a 7-valent pneumococcal conjugate vaccine 3 to 4 weeks before and a 23-valent pneumococcalpolysaccharide vaccine 3 months after tube insertion. Blood samples were drawn at the first vaccination, at the time of TT placement, and 1 and 3 months after the second vaccination. Levels of IgA and IgG serum antibody against the 7-valent pneumococcal conjugate vaccine serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F were measured with enzyme-linked immunosorbent assays. All children were monitored for recurrence of OME for 6 months after spontaneous extrusion of the TTs. RESULTS: The overall recurrence rate of bilateral OME was 50%. Pneumococcal vaccinations induced significant 4.6- to 24.4-fold increases in the geometric means of all conjugate vaccine serotype antibody titers but did not affect recurrence of OME. CONCLUSIONS: Combined pneumococcal conjugate and polysaccharide vaccination does not prevent recurrence of OME among children 2 to 8 years of age previously known to have persistent OME. Therefore, pneumococcal vaccines are not indicated for the treatment of children suffering from recurrent OME.
Authors: Jeroen D Langereis; Thijs M A van Dongen; Kim Stol; Roderick P Venekamp; Anne G M Schilder; Peter W M Hermans Journal: Med Microbiol Immunol Date: 2013-06-18 Impact factor: 3.402
Authors: Aly M N El-Makhzangy; Naema M Ismail; Salma B Galal; Tamer S Sobhy; Amal A Hegazy Journal: Eur Arch Otorhinolaryngol Date: 2012-03-03 Impact factor: 2.503
Authors: Thuy-My Le; Maroeska M Rovers; Reinier H Veenhoven; Elisabeth A M Sanders; Anne G M Schilder Journal: Eur J Pediatr Date: 2006-12-30 Impact factor: 3.183
Authors: Kim Stol; Suzanne J C Verhaegh; Kees Graamans; Joost A M Engel; Patrick D J Sturm; Willem J G Melchers; Jacques F Meis; Adilia Warris; John P Hays; Peter W M Hermans Journal: Int J Pediatr Otorhinolaryngol Date: 2013-01-29 Impact factor: 1.675