Alessandro Maida

Safety and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared to Those of a 7-Valent Pneumococcal Conjugate Vaccine Given as a Three-Dose Series with Routine Vaccines in Healthy Infants and Toddlers

ABSTRACT A 13-valent pneumococcal conjugate vaccine (PCV13) has been developed to improve protection against pneumococcal disease beyond that possible with the licensed 7-valent vaccine (PCV7). This study compared the safety and immunogenicity of PCV13 with those of PCV7 when given as part of the pediatric vaccination schedule recommended in Italy. A total of 606 subjects were randomly assigned to receive either PCV13 or PCV7 at 3, 5, and 11 months of age; all subjects concomitantly received diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type B (DTaP-HBV-IPV/Hib) vaccine. Vaccine reactions were monitored. Antibody responses to DTaP-HBV-IPV/Hib antigens, serotype-specific anticapsular polysaccharide IgG responses, and antipneumococcal opsonophagocytic assay (OPA) activity were measured 1 month after the two-dose primary series and 1 month after the toddler dose. Overall, the safety profile of PCV13 was similar to that of PCV7. The response to DTaP-HBV-IPV/Hib antigens was substantially the same with both PCV13 and PCV7. PCV13 elicited antipneumococcal capsular IgG antibodies to all 13 vaccine serotypes, with notable increases in concentrations seen after the toddler dose. Despite a lower immunogenicity for serotypes 6B and 23F after the primary series of PCV13, responses to the seven common serotypes were comparable between the PCV13 and PCV7 groups when measured after the toddler dose. PCV13 also elicited substantial levels of OPA activity against all 13 serotypes following both the infant series and the toddler dose. In conclusion, PCV13 appeared comparable to PCV7 in safety profile and immunogenicity for common serotypes, demonstrated functional OPA responses for all 13 serotypes, and did not interfere with immune responses to concomitantly administered DTaP-HBV-IPV/Hib vaccine.

Pretreatment Antibiotic Resistance in Helicobacter pylori Infection: Results of Three Randomized Controlled Studies

Background. Although combinations of antibiotics and antisecretory drugs are useful for treatment of Helicobacter pylori infection, treatment failure is common. The aim of this study was to evaluate the relation between pretreatment antibiotic resistance and outcome by using six different treatment regimens for H. pylori infection.

Amoxycillin resistance is one reason for failure of amoxycillin-omeprazole treatment of Helicobacter pylori infection

The efficacy of omeprazole and amoxycillin dual therapy to treat Helicobacter pylori infection has been inconsistent, suggesting the presence of host or bacterial factors influencing treatment success. The aim of this study was to assess the role of pre‐treatment amoxycillin resistance in the efficacy of omeprazole and amoxycillin dual therapy.

Prevalence and viral load of oncogenic human papillomavirus types associated with cervical carcinoma in a population of North Italy

A cross‐sectional study was carried out in a population of North Italy to determine the prevalence of eight oncogenic human papillomavirus (HPV) types most commonly found in cervical carcinoma and to study the relationship between HPV DNA loads and severity of disease. A total of 597 cervical samples obtained from patients with pathological findings (n = 472) and from women with normal cytology (n = 125) were analyzed by means of normalized Real‐time PCR assays to quantify HPV‐16, ‐18, ‐31, ‐45, and ‐33 group (including ‐33, ‐52, ‐58, ‐67); the normalization of oncogenic HPV viral load was carried out by quantitation of a single copy gene. The two most common oncogenic HPV types found were 16 and 31 (24.3% and 22.9% of pathological samples, respectively); multiple infections were demonstrated in 22% of pathological samples. Overall, the HPV total viral load was found to increase with increasing severity of associated lesions, although a stronger association was observed only for HPV‐31 and HPV‐16 (γ = 0.49 and 0.41, respectively) as compared to HPV‐18 and ‐33 group (γ = 0.19 and 0.02, respectively). However, we found that high levels of HPV‐31 or 33 group DNA could be prognostic of minor oncogenic risk for high‐grade squamous intraepithelial lesions (H‐SIL) (age adjusted odds ratio [AORs] = 1.57 and 1.26, respectively) than HPV‐16 and HPV‐18 (AORs = 30 and 8, respectively). The AORs also increased with HPV total viral load and reached a maximum of AORs = 15.7. Thus, HPV load is a type‐dependent risk marker for the development of H‐SIL. J. Med. Virol. 81:278–287, 2009.

Molecular methods for the detection of human papillomavirus infection: new insights into their role in diagnostics and epidemiological surveillance

Human papillomaviruses (HPVs) comprise more than 180 genotypes. HPV infection is mainly diagnosed by molecular methods. The aim of our study was to review the main molecular methods used to diagnose HPV infection, underscoring their characteristics. Several methods have been developed for molecular diagnosis of Papilloma infection, such as those based on PCR technique. Another commercial non-PCR based diagnostic method is Hybrid Capture test; it is the only commercially available HPV DNA detection test approved by the FDA. Several Authors have suggested that viral load and E6/E7 transcripts could be used as surrogate markers of persistent HPV infection, being more specific predictors of progressive disease than the simple presence of HPV DNA. Validating clinical sensitivity and specificity of each technique and improving the interpretation of the results are essential; consequently, there is a clear need for well characterized international quality control panels to compare the various diagnostic methods. HPV DNA testing could be useful both as a primary screening test, alone or in combination with a Pap smear, for the early detection of cervical cancer precursors, and as triage test to select women with minor cytological abnormalities who will need further follow-up and to predict possible treatment failure in women with diagnosed high-grade intraepithelial lesions who have undergone excisional therapy. In the next future surveillance for HPV infections, based on these molecular methods, could represent an important step for the development of primary and secondary prophylactic interventions, such as new vaccines targeted to genotypes who might replace those previously prevalent.

Cloriti e clorati nelle acque potabili della Sardegna centro-settentrionale

Introduzione: l’approvvigionamento idropotabile della Sardegna e basato quasi esclusivamente su acqua superficiale particolarmente esposta a contaminazione ambientale per il cui trattamento sono richiesti complessi sistemi di potabilizzazione. In questo contesto, l’utilizzo del biossido di cloro in sostituzione dell’ipoclorito di sodio, pur determinando la significativa riduzione dei THM, potrebbe generare ioni clorito e clorato potenzialmente dannosi per l’uomo. Obiettivi: e stata condotta un‘indagine al fine di valutare la presenza di cloriti e clorati e rilevare indicazioni utili al loro contenimento nelle acque in uscita dagli impianti di potabilizzazione della Sardegna centro-settentrionale. Materiali e metodi: in due distinte serie di campionamenti, sono stati rilevate sia concentrazioni di disinfettante in pre ed in post clorazione sia, mediante cromatografia liquida per scambio ionico secondo la procedura EPA Metodo 300.0, cloriti e clorati nei vari step della potabilizzazione di 12 impianti. Risultati: il dosaggio medio totale di ClO2 e stato di 4,63 mg/l (2,87 mg/l in preclorazione e 1,93 in postclorazione). La percentuale media di abbattimento dei cloriti da parte dei filtri a carbone attivo ha evidenziato un calo di efficacia, essendo passata da un 62,3% rilevato nel primo campionamento ad un 23,6% rilevato nel secondo campionamento. La concentrazione media di cloriti e clorati in uscita dagli impianti e stata rispettivamente di 1,66 mg/l (min. 0,72 mg/l, max. 2,98 mg/l, dev. st. 0,69) e di 1,05 mg/l (min. 0,47 mg/l, max. 1,58 mg/l, dev. st. 0,36). La concentrazione media di cloro residuo attivo libero (C.R.A.L.) e stata di 0,59 mg/l (min. 0,19 mg/l, max. 1,26 mg/l). Conclusioni: Le concentrazioni di cloriti rilevate appaiono piuttosto elevate rispetto al valore di parametro del D.L.vo 31/2001 e, unitamente alle concentrazioni dei clorati, sono indicative della necessita di adottare, quanto prima, articolati e specifici interventi per il loro contenimento.