Effect of conjugate pneumococcal vaccine followed by polysaccharide pneumococcal vaccine on recurrent acute otitis media: a randomised study (original) (raw)
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International Journal of Pediatric Otorhinolaryngology, 2006
Background: Based on two clinical trials in healthy infants the American Academy of Pediatrics (AAP) advices immunization with a 7-valent pneumococcal conjugate vaccine in children with recurrent acute otitis media (AOM). Objective: To study the efficacy of a 7-valent pneumococcal conjugate vaccine on acute otitis media recurrences, its immunogenicity and impact on nasopharyngeal Streptococcus pneumoniae carriage in children with a history of frequent acute otitis media. Methods: In this double-blind, randomized study, 74 Belgian children, aged 1-7 years, with at least 2 clinically diagnosed episodes of acute otitis media in the previous year were enrolled. Children were immunized with either a 7-valent pneumococcal conjugate vaccine followed by a 23-valent pneumococcal polysaccharide booster or a control hepatitis A vaccine. Total follow-up was 26 months. Results: Despite adequate serum IgG responses to all conjugate vaccine pneumococcal serotypes, no reduction of acute otitis media episodes was observed in the pneumococcal vaccine group as compared to the control group (rate ratio: 1.16; 95% CI: 0.69-1.96). Overall nasopharyngeal pneumococcal carriage remained stable. § Parents or guardians who were willing to participate with their child in this study signed a consent form prior to enrolment of their child. This study was conducted in accordance with the European statements for Good Clinical Practice, which includes the provisions of the Declaration of Helsinki of 1989. The medical ethics committee of the Ghent University Hospital approved the study protocol.
Clinical Infectious Diseases, 2004
Background. We recently showed that vaccination with a 7-valent pneumococcal conjugate vaccine (PCV7) followed by a 23-valent pneumococcal polysaccharide vaccine (PPSV23) failed to prevent new episodes of acute otitis media (AOM) in previously unvaccinated toddlers and children with a history of recurrent AOM. We describe in detail the impact of pneumococcal vaccinations on nasopharyngeal carriage of S. pneumoniae in this study population. Methods. The impact of vaccination with PCV7 followed by PPSV23 on pneumococcal nasopharyngeal carriage was studied in a prospective, randomized trial involving 383 children (age range, 1-7 years) with previous AOM. Nasopharyngeal swab specimens were collected at the time of first vaccination and at 6-7-month intervals during the 26-month follow-up period. Results. Overall, pneumococcal carriage rates did not diminish, remaining at ∼50% in both PCV7/PPSV23 and control vaccinees. A significant shift from conjugate vaccine-to nonconjugate vaccine-type pneumococci was observed in children aged 1-2 years, who received the conjugate vaccine twice before the polysaccharide vaccine was administered. Conjugate vaccine serotype carriage was not influenced in older children, who received the conjugate vaccine once before receiving the polysaccharide booster. Conclusions. The administration of conjugate vaccines at least twice also after 2 years of age may be mandatory for reducing the carriage of conjugate vaccine serotypes in children with recurrent AOM. Polysaccharide booster vaccination did not affect nasopharyngeal colonization with serotypes not included in the conjugate vaccine.
2003
To explore the effect of a pneumococcal conjugate vaccine on the risk of otitis media with effusion and to search for subgroups in which the vaccine had a higher or lower effect. Methods: Analyses were performed on data from the Finnish Otitis Media Vaccine Trial, a randomised controlled double-blind trial to evaluate the efficacy of pneumococcal conjugate vaccination against acute otitis media. Data on the vaccination effect against otitis media with effusion were obtained by means of symptom interview and pneumatic otoscopy during pre-scheduled follow-up visits at the age of 7 and 24 months. Two endpoint definitions were considered: otitis media/tube (otitis media or tympanostomy tube in situ (OM/T)) as the primary endpoint and otitis media with effusion as the secondary endpoint. No evidence was found of an age-dependent association with vaccination effect. Therefore, the final marginal logistic regression analyses were performed on the combined data from the two follow-up visits. Results: The risk of otitis media tended to be lower in the pneumococcal vaccine group. The odds ratio for otitis media/tube was 0.94 (95% confidence interval 0.77-1.14) and the odds ratio for otitis media with effusion was 0.90 (95% confidence interval 0.69-1.19). Presence of older siblings increased the risk of otitis media/tube and otitis media with effusion at 7 months of age. In addition, it appeared that children without older siblings and attending day-care at 24 months of age tended to benefit more from the pneumococcal conjugate vaccine. In this subgroup, the odds ratio for otitis media/tube was 0.81 (95% confidence interval 0.55-1.20) and for otitis media with effusion the odds ratio was 0.43 (95% confidence interval 0.22-0.86). Conclusion: The effect of pneumococcal conjugate vaccination on the risk of otitis media with effusion was concordant with the efficacy seen against acute otitis media, although not distinguishable from no effect in the overall analysis. In children without older siblings, vaccination appeared to reduce the point prevalence of otitis media with effusion; this effect was not apparent in children with older siblings.
Otitis Media in Fully Vaccinated Preschool Children in the Pneumococcal Conjugate Vaccine Era
Global pediatric health, 2017
Objectives. To evaluate the effect of pneumococcal conjugate vaccine (PCV13) on the burden of acute otitis media (AOM) and to evaluate the characteristics of AOM versus otitis media with effusion (OME) in the 2 PCV periods. Methods. A cohort of fully vaccinated children aged 18 to 60 months diagnosed with AOM from 2006 to 2015 was identified. Patients with otorrhea/bulging tympanic membrane were considered as true AOM, while those without bulging/otorrhea were considered to have OME. Burden of true AOM in the PCV7 and PCV13 periods and clinical features of true AOM versus OME were compared. Results. Of 393 episodes in our cohort, 50.8% occurred in PCV7 period. Burden of true AOM in the 2 PCV groups was similar: 26% in PCV7 versus 26.4% in PCV13 (odds ratio [OR] = 1.02, 95% confidence interval [CI] = 0.65-1.60). Factors significantly associated with OME were cold season (OR = 1.54, 95% CI = 1.04-2.4), fever (OR = 2.05, 95% CI = 1.29-3.3), and recurrence (OR = 2.24, 95% CI = 1.22-4.09...
Impact of Pneumococcal Conjugate Vaccination on Otitis Media: A Systematic Review
Clinical Infectious Diseases, 2012
Acute otitis media (AOM) is a leading cause of visits to physicians and of antibiotic prescriptions for young children. We systematically reviewed studies on all-cause AOM episodes and physician visits in which impact was attributed to pneumococcal conjugate vaccines, either as efficacy or effectiveness. Of 18 relevant publications found, most used the 7-valent pneumococcal conjugate vaccine (7vCRM). The efficacy of 7vCRM against all-cause AOM episodes or visits was 0%-9% in randomized trials and 17%-23% in nonrandomized trials. In observational database studies, physician visits for AOM were already declining in the 3-5 years before 7vCRM introduction (mean change, −15%; range, +14% to −24%) and continued to decline afterward (mean, −19%; range, +7% to −48%). This vaccine provides some protection against OM, but other factors have also contributed to the recent decline in OM incidence. Future effectiveness studies should thus use better-controlled methods to estimate the true impact of vaccination on AOM.
Efficacy of a Pneumococcal Conjugate Vaccine against Acute Otitis Media
New England Journal of Medicine, 2001
Background Ear infections are a common cause of illness during the first two years of life. New conjugate vaccines may be able to prevent a substantial portion of cases of acute otitis media caused by Streptococcus pneumoniae. Methods We enrolled 1662 infants in a randomized, double-blind efficacy trial of a heptavalent pneumococcal polysaccharide conjugate vaccine in which the carrier protein is the nontoxic diphtheria-toxin analogue CRM197. The children received either the study vaccine or a hepatitis B vaccine as a control at 2, 4, 6, and 12 months of age. The clinical diagnosis of acute otitis media was based on predefined criteria, and the bacteriologic diagnosis was based on a culture of middle-ear fluid obtained by myringotomy. Results Of the children who were enrolled, 95.1 percent completed the trial. With the pneumococcal vaccine, there were more local reactions than with the hepatitis B vaccine but fewer than with the combined whole-cell diphtheria-tetanus-pertussis and Haemophilus influenzae type b vaccine that was administered simultaneously. There were 2596 episodes of acute otitis media during the follow-up period between 6.5 and 24 months of age. The vaccine reduced the number of episodes of acute otitis media from any cause by 6 percent (95 percent confidence interval, ¡4 to 16 percent [the negative number indicates a possible increase in the number of episodes]), culture-confirmed pneumococcal episodes by 34 percent (95 percent confidence interval, 21 to 45 percent), and the number of episodes due to the serotypes contained in the vaccine by 57 percent (95 percent confidence interval, 44 to 67 percent). The number of episodes attributed to serotypes that are cross-reactive with those in the vaccine was reduced by 51 percent, whereas the number of episodes due to all other serotypes increased by 33 percent. Conclusions The heptavalent pneumococcal polysaccharide-CRM197 conjugate vaccine is safe and efficacious in the prevention of acute otitis media caused by the serotypes included in the vaccine. (N Engl J Med 2001;344:403-9.
BMC Infectious Diseases, 2012
Background: Several studies have investigated the impact of 7-valent pneumococcal conjugate vaccine (PCV7) on pneumococcal (Sp) and staphylococcal (Sa) nasopharyngeal (NP) carriage. Few have investigated the impact on Haemophilus influenzae (Hi) and Moraxella catarrhalis (Mc) carriage. We aimed to compare the NP carriage rates in young children with acute otitis media (AOM) before and after PCV7 implementation in France. Methods: Prior to PCV7 implementation, we performed 4 successive randomized trials with NP samples. These studies compared several antibiotic regimens for treating AOM in young children (6 to 30 months). After PCV7 implementation, to assess the impact of the vaccination program on NP flora, young children with AOM were enrolled in a prospective surveillance study. In each study, we obtained an NP sample to analyze the carriage rates of Sp, Hi, Mc and Sa and the factors influencing the carriage. Standardized history and physical examination findings were recorded; the methods used for NP swabs (sampling and cultures) were the same in all studies. Results: We enrolled 4,405 children (mean age 13.9 months, median 12.8). Among the 2,598 children enrolled after PCV7 implementation, 98.3% were vaccinated with PCV7. In comparing the pre-and post-PCV7 periods, we found a slight but non-significant decrease in carriage rates of pneumococcus (AOR = 0.85 [0.69;1.05]), H. influenzae (AOR = 0.89 [0.73;1.09]) and S. aureus (AOR = 0.92 [0.70;1.19]). By contrast, the carriage rate of M. catarrhalis increased slightly but not significantly between the 2 periods (AOR = 1.08 [0.95;1.2]). Among Sp carriers, the proportion of PCV7 vaccine types decreased from 66.6% to 10.7% (P < 0.001), penicillin intermediate-resistant strains increased from 30.3% to 43.4% (P < 0.001), and penicillin-resistant strains decreased greatly from 22.8% to 3.8% (P < 0.001). The proportion of Hi ß-lactamase-producing strains decreased from 38.6% to 17.1% (P < 0.001). Conclusion: The carriage rates of otopathogen species (Sp, Hi, Mc) and Sa did not significantly change in children with AOM after PCV7 implementation in France. However, we observed significant changes in carriage rates of PCV7 vaccine serotypes and penicillin non-susceptible Sp.