Safety and tolerability of Meningococcus B vaccine in patients with chronical medical conditions (CMC).

BACKGROUND: Invasive meningococcal disease is a serious global health threat in the world; in 2016, the European Centre for Disease Control and Prevention reported 3280 confirmed cases (including 304 deaths) of Invasive Meningococcal Diseases in Europe. In Italy, in 2017 were reported 200 cases 41% of which due to menB serogroup. From January 2013 the European Medicines Agency (EMA) has authorized the marketing of the meningococcal B vaccine 4CMenB. METHODS: The study aimed to evaluate and complement the safety profile of 4CMenB in high risk children accessing the vaccine service of the Bambino Gesù Children's Hospital. All individuals aged six weeks or more receiving the meningococcal 4CMenB (Bexsero®) vaccine that approached the vaccine Centre at the Bambino Gesù Children's Hospital in Rome, were asked to participate. All parents or caregivers of vaccinated individuals in the study period, were recruited and requested to answer to a questionnaire on adverse events following immunization (AEFI) observed after 7 days, starting from the date of vaccination. RESULTS: During the study period (October 2016-October 2017), we collected 157 completed questionnaires (out of 200 distributed). Of those 132 were first doses and 25 were booster administered doses. The median age of the study population was 4.5 years (range 0.29 to 26.8 years), the majority of subjects were high-risk individuals (64%) with chronic health conditions. Overall, 311 adverse events were reported in the 7 days after vaccine administration. In particular 147 events (47%) after administration of first dose and 58 (19%) after the booster doses. A large majority of those events, were of little clinical importance and concentrated in the 24 h after vaccine administration. No hospitalizations or Emergency Department access were reported. CONCLUSIONS: Results of our study demonstrated that the Bexsero® vaccine is almost well tolerated, with a low incidence of severe AEFIs. Our results also shown that the occurrence of AEFIs is similar within healthy and high risk children.

Pregnancy in a methylmalonic acidemia patient with kidney transplantation: a case report.

Presently pregnancy is no more exceptional in women with metabolic diseases. However, it still poses significant medical problems both before and after childbirth. The challenge is even greater if the mother has undergone organ transplantation, because of her metabolic disease. We report on a case of pregnancy in a patient 29-year-old with methylmalonic acidemia cblA type (OMIM 251100) who received a renal transplantation at the age of 17 for end-stage renal disease (ESRD) caused by her primary disease. During pregnancy neither metabolic crises nor renal function changes were observed in the mother, with the only exception of a mild increase of her systemic blood pressure. To the fetus pregnancy was uneventful and during the first 30 months after birth the baby's neuropsychomotor development was normal and there were no episodes of metabolic derangement. This is evidence that methylmalonicacidemia cblA, even when treated with renal transplantation for inherent ESRD, is no contraindication to pregnancy. It is even possible that a functioning transplanted kidney contributes to improve metabolic parameters.

Comparison of times of intervention during pediatric CPR maneuvers using ABC and CAB sequences: a randomized trial.

BACKGROUND: The proposed introduction of the CAB (circulation, airway, breathing) sequence for cardiopulmonary resuscitation has raised some perplexity within the pediatric community. We designed a randomized trial intended to verify if and how much timing of intervention in pediatric cardiopulmonary resuscitation is affected by the use of the CAB vs. the ABC (airway, breathing, circulation) sequence. PATIENTS AND METHODS: 340 volunteers, paired into 170 two-person teams, performed 2-rescuer healthcare provider BLS with both a CAB and ABC sequence. Their performances were audio-video recorded and times of intervention in the two scenarios, cardiac and respiratory arrest, were monitored. RESULTS: The CAB sequence compared to ABC prompts quicker recognition of respiratory (CAB vs. ABC=17.48 ± 2.19 vs. 19.17 ± 2.38s; p<0.05) or cardiac arrest (CAB vs. ABC=17.48 ± 2.19 vs. 41.67 ± 4.95; p<0.05) and faster start of ventilatory maneuvers (CAB vs. ABC=19.13 ± 1.47s vs. 22.66 ± 3.07; p<0.05) or chest compressions (CAB vs. ABC=19.27 ± 2.64 vs. 43.40 ± 5.036; p<0.05). CONCLUSIONS: Compared to ABC the CAB sequence prompts shorter time of intervention both in diagnosing respiratory or cardiac arrest and in starting ventilation or chest compression. However, this does not necessarily entail prompter resumption of spontaneous circulation and significant reduction of neurological sequelae, an issue that requires further studies.

Environmental surveillance of poliovirus in Italy: pilot study.

A pilot study on environmental surveillance of poliovirus included one hundred ninety-six samples (drinking water, surface water, seawater and sewage), collected between 1996 and 1998 in different regions of Italy. Samples were screened for the presence of poliovirus and other enteric viruses. Twelve polioviruses, 35 non polio enteroviruses (NPE) and 51 enteric non entero (NE) viruses were isolated. All poliovirus isolates, namely four type 1, four type 2 and four type 3, were characterised as Sabin-like strains. Thirty-one Coxsackie B and 4 Echo viruses were also detected. The presence of Sabin-like polioviruses in the environment is not unexpected since immunization with only oral poliovirus vaccine was performed in Italy until May 1999, when a sequential schedule consisting of two doses of inactivated polio vaccine (IPV) and two of oral polio vaccine (OPV) was adopted; in July 2002 a schedule consisting of four doses of IPV was adopted. Although this is only a pilot study and the number of samples analysed is limited, so far data from this study so far supports once again evidence of lack of circulating wild poliovirus and is in line with results from AFP surveillance in Italy and stool survey on healthy children.

[Evaluation of the immune status against poliomyelitis in a group of young immigrants]. / Valutazione dello stato immunitario verso la poliomielite in un campione di giovani immigrati.

The immunity state towards poliomyelitis has been evaluated in 506 young immigrants coming from European and extraeuropean countries without immunization history. Polioviruses 1, 2 and 3 antibodies were detected in 97% of the serum samples. 15 subjects did not have detectable antibodies at 1:2 dilution for one or two polioviruses. Out of these subjects, 6 (coming mostly from East European Region) were negative in the undiluted serum too. On the whole, GMTs for type 1 (43,29) and 2 (41,9) appeared higher than those for type 3 (33,6). Moreover there are differences among the origin countries; in fact, GMTs more elevated for type 1 and 3 (74,6 and 49,6 respectively) have been observed in the subjects coming from the African region, as well in those coming from the American region.

Enterovirus surveillance of Italian healthy children.

Surveillance of acute flaccid paralysis (AFP) is the golden strategy recommended by the WHO to verify the condition of polio eradication in a country. Because of the difficulty to detect all of the expected AFP cases and to reach the target incidence of 1/100,000 requested by WHO, the surveillance of enteroviruses in the population has been adopted by several countries as an important additional method to verify the absence of wild-poliovirus circulation. To complete the results of AFP surveillance set up in Italy in 1996, we have conducted a wild poliovirus surveillance by examining stool samples from 1551 healthy children aged less than 5 years, collected during the period January 1997 to January 1998. The children were from three cities (Parma, Rome and Bari) located in northern, central and southern Italy. Thirty-nine polioviruses, 72 non-polio enteroviruses and 50 enteric, nonentero (NE), viruses were isolated from stool specimens. Polioviruses identified were nine type 1, seven type 2 and twenty-three type 3. Characterization of isolates by both antigenic and molecular methods showed that all polioviruses were of vaccine origin. As expected, most polioviruses, especially types 2 and 3, presented retromutations known to be associated with loss of the Sabin attenuated phenotype. The results of this study support the data obtained from the active AFP surveillance conducted in Italy in the same period--on the absence of paralytic disease due to wild poliovirus--and altogether demonstrate the effectiveness of the vaccination program.

[Measurement of anti-HBs antibodies in a population of 18-year-olds 6 years after the primary vaccination series]. / Valutazione degli anticorpi anti-HBs in un campione di diciottenni a 6 anni dal ciclo vaccinale primario.

We have analized the persistence of vaccine-induced antibodies to hepatitis B surface antigen, in a cohort of 445 eighteen-year-old males, who had been immunized against hepatitis B six years earlier (when they were 12 years old, according to the Italian law). These young men were about to begin their military service and were going through the routine check-up. They came from two different towns Reggio Emilia and Mantova, in the north of Italy, and were divided into two groups (group A no 258 men, group B no 187 men) depending on where they had been vaccinated. The serologic results showed that 97% of subjects had anti-HBs and 94% anti-HBs protective levels (> or = 10 mIU/ml). Moreover 81% of responder subjects showed titles > or = 100 mIU/ml, and 25% showed titles even > or = 1000 mIU/ml. Anti-HBs GMT of the total responders was 367.1. Differences have been found in the anti-HBs levels of men vaccinated in the two different towns.

The prevalence of HCV infection in a cohort of pregnant women, the related risk factors and the possibility of vertical transmission.

The prevalence of antibodies for one or more HCV antigens was 2.3% of 1,347 mothers at childbirth. Compared with the principal factors studied, the presence of antibodies was more frequent in women who were carriers of HIV infection (3/3), in those who had suffered liver diseases (5/37) or who had had transfusion (3/25). This was as opposed to women who did not have any risk factor (p < 0.001). The prevalence of HCV-RNA was 1.3%; in relation to the antibody state, such a condition was more frequent in subjects with antibodies for 3 or 4 antigens (about 80%) compared with those who were positive for 1 or 2 antigens. HCV-RNA of the same genotype as the mother (type 1; 1a) was also found in the funicular blood of 2 of the 18 babies born to mothers who were positive for HCV-RNA. In the course of the follow-up (from the 3rd to the 18th month) the viral RNA was not found in any of the babies, nor was it found in the 2 who were positive at birth. Even the antibodies gradually disappeared, although slowly. At the 10th month, 91% of the babies resulted as having no antibodies and at the 18th month none of the babies resulted as having antibodies. Breast-feeding also appeared to have no influence on the transmission of the infection; out of 18 viremic mothers indeed 12 (67%) breast-fed their babies.

Antipoliomyelitis neutralizing antibodies in maternal and neonatal serum.

During 1993 blood samples were taken from 1251 women consecutively admitted to the Maternity Ward of the University of Parma. Samples were also taken from all the newborn babies. Absence of antipolio neutralizing antibodies in serum diluted 1/2 was shown in 6 mothers; 4 mothers for polio 1, 1 mother for polio 2 and 1 simultaneously for the poliovirus 1 and 3. If one considers only the cases of absence in undiluted serum, there were 2 negative subjects (0.16%). One of these was for antibodies against polio 1 and the other for antibodies against polio 2. In the cord blood samples the frequency of negative results in serum diluted 1/2 is higher: 42 in all with 13 babies negative for polio 1. 17 babies for polio 2, 8 for polio 3 and 2 babies simultaneously for polio 1 and polio 3. If one considers just the babies without antibodies even in undiluted serum, the fraction of seronegatives is 9 (0.7%) with 1 for polio 1, 6 for polio 2 and 1 for types 1 and 3. The Geometric Mean Titres of the antibodies are significantly higher in mothers born before 1964 (year of introduction of mass vaccination with OPV) compared with those born after that year. Likewise, the same phenomenon was observed in the respective children.

Antipoliomyelitis immunity status among a population that was regularly vaccinated 11-12 years before.

A study of poliomyelitis neutralizing antibodies was carried out on 165 samples of blood serum drawn from subjects aged 14-15 years who had completed vaccination with OPV 11 or 12 years ago. Two different methods of incubation of the serum-virus mixtures (1 hour at 37 degrees C; 6 hours at 37 degrees C and then 18 hours at 4 degrees C, respectively) and two different cell lines (RC-37 and Hep-2) for the inoculation of these mixtures were employed. The results were also evaluated in relation to different initial dilutions of the sera (from 1:4 to 1:1). With the 1:4 initial serum dilution the highest frequencies of sero-negativity were observed utilizing the short incubation time and inoculation in Hep-2 (42% for polio 1, 10% for polio 2, 32% for polio 3). These frequencies diminish significantly utilizing the RC-37 cell line and the long incubation respectively. Under all the experimental conditions the results were better when the 1:2 initial serum dilutions were employed and even better when undiluted sera were used. Neutralizing antibodies against the 3 types of poliovirus were detected in the undiluted sera of all the subjects utilizing the long incubation and inoculation in either the RC-37 or the Hep-2 cell lines. In three subjects lacking detectable antibodies at the 1:4 dilution of the sera, the administration of a dose of IPV produced after 5-7 days a high response which remained almost unchanged 30 days later.

[Salmonellae in the Parma River: 2 years of monitoring]. / Le salmonelle nel torrente Parma: due anni di monitoraggio.

During the period April 1987-February 1989 the contamination of Parma river by Salmonella was studied. These pathogens were almost constantly isolated all over the period of survey (91.7% of samples were positive). The concentration of Salmonella Spp, evaluated as MPN/1, appeared to be also remarkable, ranging from 1 to 92/l. The variety of serotypes appeared furthermore considerable either regarded on the whole (38 serotypes) or related to the single drawings (from 2 to 14 serotypes simultaneously present in 90.9% of samples). Some serotypes as: S. typhimurium, S. livingstone, S. brandenburg, S. panama, have been recovered from most of samples, some others as S. give, S. Stanleyville, S. agona have been recovered only in a few times.