Abstract
Objetivo
Evaluar la efectividad de la vacunación antineumocócica 23-valente en la prevención de infecciones neumocócicas graves en población mayor de 50 años.
Diseño
Estudio de casos y controles.
Emplazamiento
Atención primaria de salud (Región Sanitaria de Tarragona).
Participantes
Un total de 270 pacientes >50 años con una enfermedad neumocócica grave (incluidas la enfermedad invasiva y las neumonías neumocócicas no bacteriémicas) y un total de 540 controles seleccionados aleatoriamente en los registros de usuarios de los centros de salud de referencia de los casos (tras aparejamiento por edad, sexo, médico de cabecera y estrato de riesgo para neumonía).
Mediciones principales
Como medida del efecto se usará la odds ratio (OR), realizándose un análisis multivariante de regresión logística para el control de los posibles factores de confusión, estimándose unas OR ajustadas y calculándose la efectividad vacunal (EV) mediante la fórmula: EV = 1 – OR. Se discriminará la efectividad de la vacuna para los diferentes grupos de edad y en cada uno de los estratos de riesgo. Finalmente, se evaluará también la efectividad vacunal mediante un análisis de cohortes indirectas, considerando como casos los episodios causados por serotipos vacunales y como controles los episodios causados por serotipos no incluidos en la vacuna.
Discusión
El estudio podrá dar una respuesta en términos de efectividad de la vacuna para diferentes estratos etarios y de riesgo, y contribuirá a una toma de decisiones respecto al controvertido tema de la indicación sistemática o no de esta vacuna en las personas mayores.
Palabras clave: Efectividad, Vacuna antineumocócica, Casos y controles, Enfermedad neumocócica invasiva, Neumonía neumocócica
Abstract
Objective
To assess the effectiveness of 23- valent polysaccharide vaccine in preventing severe pneumococcal infections in adults over 50 years old.
Design
Case-control study.
Setting
Primary Health Care Service, Tarragona, Spain.
Patients
A total of 270 patients >50 with severe pneumococcal disease (invasive pneumococcal disease and non-bacteraemic pneumococcal pneumonia) and 540 control patients randomized from the primary care Centres of the case patients. Case and control patients will be matched for age, sex, family physician, and level of risk for pneumonia.
Main measurements
Odds ratio (OR) will be used to measure the vaccine effect. Multivariate logistical regression, adjusted for age, sex, and comorbidity, will be conducted. Vaccine effectiveness (VE) will be calculated by the formula, VE=1-OR. Vaccine effectiveness will be distinguished for the various age groups and at each risk stratum. It will also be estimated by means of indirect cohort analysis, taking as cases the infection caused by vaccine serotypes and as controls infection caused by nonvaccine serotype.
Discussion
The study will give an answer in terms of effectiveness of the vaccine for several age and risk strata. It will contribute to taking a decision regarding the controversial question of the systematic indication, or otherwise, of this vaccine for the elderly.
Key words: Effectiveness, Pneumococcal vaccine, Case-control, Invasive pneumococcal disease, Pneumococcal pneumonia
Bibliografía
- 1.Fine M.J., Smith M.A., Carson C.A., Meffe F., Sankey S.S., Weissfeld L.A. Efficacy of pneumococcal vaccination in adults. A meta-analysis of randomized controlled trials. Arch Intern Med. 1994;154:2666–2677. doi: 10.1001/archinte.1994.00420230051007. [DOI] [PubMed] [Google Scholar]
- 2.Puig-Barberá J., Belenguer A., Goterris M., Brines M.J. Efectividad de la vacuna frente al neumococo en el anciano. Revisión sistemática y meta-análisis. Aten Primaria. 2002;30:269–282. doi: 10.1016/S0212-6567(02)79027-6. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Dear K., Holden J., Andrews R., Tatham D. Vaccines for preventing pneumococcal infection in adults. Cochrane Database Syst Rev. 2003;(4) doi: 10.1002/14651858.CD000422. CD000422. [DOI] [PubMed] [Google Scholar]
- 4.Fedson D.S., Lise C. Precise answers to the wrong question: prospective clinical trials and the meta-analyses of pneumococcal vaccine in elderly and high-risk adults. Vaccine. 2004;22:927–946. doi: 10.1016/j.vaccine.2003.09.027. [DOI] [PubMed] [Google Scholar]
- 5.Melegaro A., Edmunds W.J. The 23-valent pneumococcal polysaccharide vaccine. Part I. Efficacy of PPV in the elderly: comparison of meta-analyses. Eur J Epidemiol. 2004;19:353–363. doi: 10.1023/b:ejep.0000024701.94769.98. [DOI] [PubMed] [Google Scholar]
- 6.Vila A., Ochoa O., Hospital I., Marín M.L., Guinea I., Álvarez M. Efectividad de la vacuna antineumocócica en pacientes mayores de 65 años. Medifam. 2003;13:297–304. [Google Scholar]
- 7.Jackson L.A., Neuzil K.M., Yu O., Benson P., Barlow W.E., Adams A.L. Effectiveness of pneumococcal polysaccharide vaccine in older adults. N Engl J Med. 2003;348:1747–1755. doi: 10.1056/NEJMoa022678. [DOI] [PubMed] [Google Scholar]
- 8.Andrews R., Counahan M., Hogg G., McIntyre P. Effectiveness of a publicy funded pneumococcal vaccination program against invasive pneumococcal disease among the elederly in Victoria, Australia. Vaccine. 2004;23:132–138. doi: 10.1016/j.vaccine.2004.06.016. [DOI] [PubMed] [Google Scholar]
- 9.Vila-Córcoles A., Ochoa-Gondar O., Llor C., Hospital I., Rodríguez T., Gómez A. Protective effect of pneumococcal vaccine against death by pneumonia in elderly subjects. Eur Respir J. 2005;26:1086–1095. doi: 10.1183/09031936.05.00030205. [DOI] [PubMed] [Google Scholar]
- 10.Benin A.L., O’Brien K.L., Watt J.P., Reid R., Zell E.R., Katz S. Effectiveness of the 23-valent polysaccharide vaccine against invasive pneumococcal disease in Navajo adults. J Infect Dis. 2003;188:81–89. doi: 10.1086/375782. [DOI] [PubMed] [Google Scholar]
- 11.Domínguez A., Salleras L., Fedson D.S., Inquierdo C., Ruiz L., Ciruela P. Effectiveness of pneumococcal vaccination for elderly people in Catalonia, Spain. Clin Infect Dis. 2005;40:1250–1257. doi: 10.1086/429236. [DOI] [PubMed] [Google Scholar]
- 12.Gaillat J., Zmirou D., Mallaret M.R., Rouhan D., Bru J.P., Stahl J.P. Clinical trial of an anti-pneumococcal vaccine in elderly people living in institutions. Rev Epidemiol Sante Publique. 1985;33:437–444. [PubMed] [Google Scholar]
- 13.Wagner C., Popp W., Posch M., Vlasich C., Rosenberger-Spitzy A. Impact of pneumococcal vaccination on morbidity and mortality of geriatric patients: a case-controlled study. Gerontology. 2003;49:246–250. doi: 10.1159/000070405. [DOI] [PubMed] [Google Scholar]
- 14.Vila Corcoles A., Ochoa Gondar O., Llor C. Methodology of observational studies of pneumococcal polysaccharide vaccine. Lancet Infec Dis. 2004;4:71. doi: 10.1016/S1473-3099(04)00922-3. [DOI] [PubMed] [Google Scholar]
- 15.Rosón B., Fernández-Sabé N., Carratalá J., Verdaguer R., Dorca J., Manresa F. Contribution of a urinary antigen assay (Binax Now) to the early diagnosis of pneumococcal pneumonia. Clin Infect Dis. 2004;38:222–226. doi: 10.1086/380639. [DOI] [PubMed] [Google Scholar]
- 16.Fine M.J., Auble T.E., Yealy D.M., Hanusa B.H., Weissfeld L.A., Singer D.E. A prediction rule to identify low-risk patients with community-adquired pneumonia. N Engl J Med. 1997;336:243–250. doi: 10.1056/NEJM199701233360402. [DOI] [PubMed] [Google Scholar]
- 17.Lim W.S., Van der Eerden M.M., Laing R., Boersma W.G., Karalaus N. Defining community acquired pneumonia severity on presentation to hospital: an international derivation and validation estudy. Thorax. 2003;58:377–382. doi: 10.1136/thorax.58.5.377. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Broome C.V., Facklam R.R., Fraser D. An alternative method to estimate the efficacy of pneumococcal vaccine. N Engl J Med. 1980;303:549–552. doi: 10.1056/NEJM198009043031003. [DOI] [PubMed] [Google Scholar]
- 19.Álvarez M.J., Mayer M.A. El dilema sobre el coste efectividad de la vacuna antineumocócica sigue abierto. Medifam. 2001;3:115–121. [Google Scholar]
- 20.Aller A.I., Garjón F.J., Buisán M.J., Palacín J.C. ¿Está justificada la vacunación contra el neumococo en mayores de 65 años? Aten Primaria. 2002;7:433–437. doi: 10.1016/S0212-6567(02)70601-X. [DOI] [PMC free article] [PubMed] [Google Scholar]