Streptorix - Vacuna experimental reduce significativamente los casos de otitis media en lactantes
Dr. Manuel Rodríguez Lanza
Revisión: 08/03/2006
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PUBLICIDAD
PUBLICIDAD
Los resultados de un ensayo clínico de fase III realizado por investigadores de la Universidad de Defense (República Checa) indican que una nueva vacuna desarrollada podría reducir a la mitad los casos de infección del oído medio en niños pequeños.
En el estudio, la vacuna redujo los casos de otitis media en un 30% en aquellos lactantes que habían sido vacunados durante los primeros 6 meses de vida, tal como publican en 'The Lancet'.
Los autores explican que la infección del oído medio causa fiebre, dolor y a veces disminuye la capacidad auditiva. La vacuna experimental se ha ensayado en un grupo de casi 5.000 lactantes, distribuidos para recibir tres dosis de la nueva vacuna, llamada comercialmente Streptorix, y una dosis de recuerdo a los 15 meses, o bien recibieron la vacuna contra la hepatitis A como grupo control.
Los resultados muestran una disminución estadísticamente significativa y clínicamente relevante de los episodios de otitis media aguda.
Se prevé pedir la autorización de la nueva vacuna en Europa en el año 2007.
La empresa GlaxoSmithKline (GSK)
planea invertir 18.000 millones de dólares en los próximos cinco
años en el desarrollo de cinco vacunas, aunque todavía las
autoridades norteamericanas no han fijado fecha para
comercializar su vacuna para el cáncer cervical, informó hoy la
compañía.
El laboratorio espera introducir en el año 2010 sus vacunas para
el cáncer cervical, 'Cervarix' y 'Rotarix'; para el rotavirus, 'Streptorix';
para el neumococo; su vacuna mejorada frente a la gripe y la
combinada para la meningitis.
GSK prevee que el mercado global de estas vacunas alcanzará de
11.000 a 18.000 millones de dólares en cinco años. Las vacunas
suponen un 6 por ciento de los 20.000 millones de dólares que
facturó el laboratorio el año pasado.
Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study
Enlaces de interes:
Streptorix - Going Beyond Prevnar
van Heerbeek N, Straetemans M, Wiertsema SP, Ingels KJ, Rijkers GT, Schilder AG, Sanders EA, Zielhuis GA. Pediatrics. 2006 Mar;117(3):603-8.
Department of Otorhinolaryngology, Radboud University Nijmegen Medical Centre, PO Box 9101, Nijmegen 6500 HB, The Netherlands. n.vanheerbeek@kno.umcn.nl
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.
Laval CB, de Andrade AL, Pimenta FC, de Andrade JG, de Oliveira RM, Silva SA, de Lima EC, Fabio JL, Casagrande ST, Brandileone MC. Clin Microbiol Infect. 2006 Jan;12(1):50-5.
Communicable Disease Surveillance, Secretariat of Health of the Municipality of Goiania, Brazil.
Nasopharyngeal carriage of Streptococcus pneumoniae is a key factor in the development of invasive disease and the spread of resistant strains within the community. A single nasopharyngeal swab was obtained from 648 unvaccinated children aged <5 years, either healthy or with acute respiratory tract infection or meningitis, during the winters of 2000 and 2001. The overall pneumococcal carriage rate was 35.8% (95% CI 32.1-39.6). The pneumococcal serotypes found most frequently in the nasopharynx were 14, 6B, 6A, 19F, 10A, 23F and 18C, which included five of the seven serotypes in the currently licensed seven-valent conjugate vaccine (PCV7); serotypes 4 and 9V were less common. Serotypes 1 and 5 were isolated rarely from the nasopharynx. A comparison of 222 nasopharyngeal isolates with 125 invasive isolates, matched for age and time to the carrier isolates, showed a similar prevalence of penicillin non-susceptible pneumococci (PNSp) (19.8% and 19.2%, respectively). PNSp serotypes were similar (6B, 14, 19F, 19 A, 23B and 23F) for carriage and invasive disease isolates. The coverage of PCV7 for carriage isolates (52.2%) and invasive isolates (62.4%) did not differ significantly (p 0.06); similarly, there was no significant difference in PCV7 coverage for carriage isolates (34.5%) and invasive isolates (28.2%) of PNSp. These data suggest that PCV7 has the potential to reduce pneumococcal carriage and the number of carriers of PNSp belonging to vaccine serotypes.
Billal DS, Hotomi M, Tasnim S, Fujihara K, Yamanaka N. ORL J Otorhinolaryngol Relat Spec. 2006 Jan 30;68(3):135-138
Department of Otolaryngology-Head and Neck Surgery, Wakayama Medical University, Wakayama, Japan.
The increasing difficulty in the management of pneumococcal acute otitis media in parallel with increases in antimicrobial-resistant strains has led to much interest in pneumococcal capsular types for the adoption of effective prevention by vaccines. This study shows that multiplex polymerase chain reaction is a valuable and expeditious method for the capsular typing of pneumococci. The multiplex polymerase chain reaction method accurately detects the majority of serotypes and serogroups frequently isolated from pediatric patients with acute otitis media, allowing the characterization of the colonization patterns for further implications of pneumococcal vaccines. Copyright (c) 2006 S. Karger AG, Basel.