Potential effect of PCV13 introduction on Emergency Department accesses for lower respiratory tract infections in elderly and at risk adults.

Liguria, an administrative region in northern Italy characterized by a decade of high PCV coverage in paediatric age group, has issued new PCV13 recommendations for free active immunization in adults with risk factors and subjects aged ≥ 70 years old. Main aims of this study are: (1) a descriptive epidemiology of the clinical burden of lower respiratory tract infections (LRTI) in adults ≥18 years of age; and (2) a crossover evaluation of the effect of introduction of PCV13 vaccination in adults aged ≥70 years old, in terms of ED accesses for LRTI, obtained by a Syndrome Surveillance System (SSS). The ED access, chief complaint based SSS will allow an active surveillance of a population cohort of >430 000 individuals resident in Genoa metropolitan area, aged ≥18 years old, for a period of 60 months. During pre-PCV period, annual cumulative incidence of ED accesses for LRTI was equal to 7/1000 and 2% in ≥65 and ≥85 year adults, respectively. In ≥65 years adults, more than 70% of subjects identified by the SSS has at least one risk condition, with a peak of 87% in ≥85 year cohort. New Ligurian PCV13 recommendations can potentially reach more than 75% of ED accesses for LRTI. Data highlights the heavy impact of LRTI in terms of ED accesses, especially in the elderly and subjects with chronic conditions and the usefulness of SSS tool for monitoring PCV vaccination effect.

Safety and tolerability of 13-valent pneumococcal conjugate vaccine in the elderly.

BACKGROUND: In September 2011 the European Medical Agency authorized the use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ≥50 years. The same occurred in the US in December 2011 when the Food and Drug Administration approved the use of PCV13 in the same target age-group with indication for the prevention of invasive pneumococcal diseases and community acquired pneumonia sustained by the serotypes contained in the vaccine. The Liguria Region, in Italy, implemented in 2013 an active and free of charge immunization strategy with PCV13 among adults affected by specific risk conditions and the elderly aged ≥70 years. METHODS: An observational study was performed in order to assess the safety and tolerability of PCV13 among elderly dwelling in the metropolitan area of Genoa, the capital city of Liguria Region. Eligible subjects, who received PCV13 following the public health immunization campaign at the Local Health Unit 3 of Genoa, provided a written informed consent to take part in the study. Eight-hundred-seventy-one subjects were enrolled between October 2013 and May 2014: all were monitored by qualified healthcare personnel for at least 30 min after vaccination at the outpatient clinics, in order to assess any possible sudden reaction. The occurrence of a series of local and systemic solicited reactions and of any unsolicited Adverse Events (AEs) was monitored using a self-administered clinical diary and by regular phone contacts up to 14 and 21 d following immunization, respectively. Moreover, a 6-months follow-up following vaccination was planned in order to monitor Severe Adverse Events (SAEs). RESULTS: No sudden reaction occurred in vaccinees at the outpatient clinics. Pain (27.4%) was the most frequent reaction reported by subjects at the injection site, while new muscle pain (13.6%), fatigue (10.7%), and headache (9.9%) resulted the most common systemic reactions. Rates of the main reactions reported in this on-field study resulted generally lower than those registered in clinical trials performed in the elderly. The incidence of fever (2.2%) following vaccination was low at values superimposable to that reported in previous studies. CONCLUSION: This observational study showed a good safety and tolerability of PCV13 among the elderly in routine clinical practice further confirming the evidence coming from clinical trials in the same age-group.

[Immunization campaign with 13-valent Pneumococcal Conjugate Vaccine in adults in Liguria Region, Italy: one year post-introduction preliminary results]. / Campagna di immunizzazione con vaccino antipneumococcico coniugato 13-valente nella popolazione adulta in Liguria: risultati preliminari a un anno dall'introduzione.

OBJECTIVE: To assess the impact of the immunization program with 13-valent Pneumococcal Conjugate Vaccine (PCV13) in adults, from October 2013 in Liguria, Italy, both in terms of effectiveness, and tolerability and safety. METHODS: First study: descriptive epidemiology of the clinical burden of lower respiratory tract infections (LRTI) and the role of risk factors or co-morbidity in adults >18 years of age. Second study: crossover evaluation of the effect of PCV13 introduction in adults aged ≥70 years, in terms of ED accesses for LRTI, obtained by a Syndrome Surveillance System (SSS) operating in Liguria from 2007. Third study: evaluation of safety and tolerability profile of PCV13 in terms of local and systemic solicited and unsolicited adverse events. RESULTS: During pre-PCV period, annual cumulative incidence of ED accesses for LRTI was equal to 7/1000 and 2% in ≥65 and ≥85 year adults, respectively. In ≥65 years adults, more than 70% of identified subjects has at least one risk condition. A significant reduction in the incidence of ED accesses for LRTI in the vaccinated population, compared to non-vaccinated subjects, has already been observed: the preventive fraction, adjusted for age and seasonality, was estimated to be nearly 20%. PCV13 had a good safety and tolerability profile: rates of local (32%) and systemic (22%) solicited reactions resulted generally lower than those registered in clinical trials previously performed in the elderly. CONCLUSIONS: Preliminary PCV13 assessments regarding safety and tolerability profile, together with the initial effects of the immunization program in terms of reduction of ED accesses for LRTI, confirmed the effectiveness of current Liguria Region recommendations for the prevention of pneumococcal disease in adult population.

Acceptance and safety of the intradermal influenza vaccine among the elderly in Italy: an on-field national study.

INTRODUCTION: An observational multicenter study was carried out in Italy, to evaluate the acceptability and safety of the new intradermal (ID) influenza vaccine (Intanza Sanofi Pasteur SA, Lyon, France) among subjects aged≥60 years, compared with that of other intramuscular (IM) influenza vaccines. Compliance with the use of the ID vaccine by healthcare professionals was also assessed. METHODS: A previously validated and self-administered questionnaire, Vaccinees' Perception of Injection (VAPI®), consisting of 21 questions, mainly focused on four dimensions (bother, arm movements, sleep, and acceptability), was administered to >1,600 individuals with spontaneous access to outpatient clinics, located in Northern, Central, and Southern Italy, to evaluate the acceptance of the vaccines. Occurrence of solicited and unsolicited side effects and of serious adverse events was assessed in a subset of subjects (n=500), using a clinical diary filled in by vaccinees following immunization. Compliance with the new ID vaccine by healthcare professionals was investigated using an ad-hoc questionnaire. RESULTS: A very favorable opinion concerning the acceptability of both the vaccines under survey, with the most positive answers ranging between 75.5% and 94.9%, was registered within the study population. Also the compliance by healthcare professionals (n=130) with the novel ID vaccine was favorable. No serious adverse event occurred during the 6-month follow-up period. The frequency of solicited systemic reactions was comparable between the two study groups, while solicited local reactions were significantly higher in the ID-vaccine group than in the IM-vaccine group, even if at values lower than those reported in phase 3 clinical trials (ranges=18.5-32.6% vs. 29.5-70.9%). These local events were mild and transient, thus without any clinical relevance. CONCLUSION: The novel ID influenza vaccine can be widely recommended in clinical practice, representing a useful tool to improve immunization coverage rates, and thus the control of influenza.

Universal childhood immunisation against Streptococcus pneumoniae: the five-year experience of Liguria Region, Italy.

Liguria was the first Italian Administrative Region, since 2003, to actively recommend free-of-charge immunisation, of all infants, with heptavalent Pneumococcal Conjugate Vaccine (PCV-7), within a research pilot-project. Vaccination coverage among infants rapidly increased from 42.8% in 2003 to 83.3% in 2004, progressively reaching levels of 93.4% in 2007. Two scientific projects have been carried out, aimed: (i) to assess the immunogenicity of PCV-7 and of a hexavalent vaccine Diphtheria-Tetanus-Trivalent Acellular Pertussis-Hepatitis B-Inactivated Polio Virus-Haemophilus influenzae type B (DTaP-HBV-IPV-Hib) when co-administered to healthy infants at 3, 5 and 11-12 months of age (routine schedule), and (ii) to evaluate the effect of the immunisation campaign in preventing pneumococcal-associated hospitalisations. Results in 151 infants showed the high immunogenicity of the vaccines, seroprotection rates, measured 1 month after the third dose, ranging between 97.3% (serotype 6 B) and 100% (serotypes 4 and 9 V) for PCV-7 and between 99.3% and 100% against common antigens of hexavalent vaccine. Monitoring nearly 70,000 children, aged 0-24 months, during the period 2000-2007, and comparing hospitalisation rates occurred in subjects belonging to birth cohorts before and after the introduction of widespread immunisation, a significant decline for all-cause and pneumococcal pneumonia and for acute otitis media was observed, with preventive fractions of 15.2%, 70.5% and 36.4%, respectively.