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Godon O.,Institute Pasteur Paris | Fontaine H.,French Institute of Health and Medical Research | Kahi S.,French Institute of Health and Medical Research | Meritet J.F.,Virology Unit | And 4 more authors.
Molecular Therapy | Year: 2014

A substudy of a phase I/II, prospective, multicenter clinical trial was carried out to investigate the potential benefit of therapeutic vaccination on hepatitis B e antigen-negative patients with chronic hepatitis B (CHB), treated efficiently with analogues. Patients were randomized in 2 arms, one receiving a hepatitis B virus (HBV) envelope DNA vaccine, and one without vaccination. At baseline, HBV-specific interferon (IFN)-γ-producing T cells were detected in both groups after in vitro expansion of peripheral blood mononuclear cells. Vaccine-specific responses remained stable in the vaccine group, whereas in the control group the percentage of patients with HBV-specific IFN-γ-producing T cells decreased over time. The vaccine-specific cytokine-producing T cells were mostly polyfunctional CD4+ T cells, and the proportion of triple cytokine-producer T cells was boosted after DNA injections. However, these T-cell responses did not impact on HBV reactivation after stopping analogue treatment. Importantly, before cessation of treatment serum hepatitis B surface antigen (HBsAg) titers were significantly associated with DNA or HBsAg clearance. Therapeutic vaccination in CHB patients with persistent suppression of HBV replication led to the persistence of T-cell responses, but further improvements should be searched for to control infection after treatment discontinuation. © The American Society of Gene & Cell Therapy.

Memish Z.A.,Preventive Medicine | Assiri A.M.,Ministry of Health | Hussain R.,Virology Unit | Alomar I.,Administration of Laboratories and Blood Banks | Stephens G.,Preventive Medicine Directorate
Journal of Travel Medicine | Year: 2012

Background. The objectives of this study were to determine whether pilgrim attendance at the Hajj was associated with an increased risk of acquiring influenza, and other respiratory viruses, and to evaluate the compliance of pilgrims with influenza vaccination and other recommended preventive measures. Methods. A cross-sectional survey was conducted among pilgrims as they arrived at the King Abdulaziz International Airport in Jeddah for the 2009 Hajj and as they departed from the same airport during the week after the Hajj. Nasopharyngeal and throat swabs were tested for 18 respiratory virus types and subtypes using the xTAG Respiratory Viral Panel FAST assay. Results. A total of 519 arriving pilgrims and 2,699 departing pilgrims were examined. Their mean age was 49 years and 58% were male. In all, 30% of pilgrims stated that they had received pandemic influenza A(H1N1) vaccine before leaving for the Hajj and 35% of arriving pilgrims reported wearing a face mask. Only 50% of arriving pilgrims were aware of preventive measures such as hand hygiene and wearing a mask. The prevalence of any respiratory-virus infection was 14.5% (12.5% among arriving pilgrims and 14.8% among departing pilgrims). The main viruses detected (both groups combined) were rhinovirus-enterovirus (N = 414, 12.9%), coronaviruses (N = 27, 0.8%), respiratory syncytial virus (N = 8, 0.2%), and influenza A virus (N = 8, 0.2%) including pandemic influenza A(H1N1) (N = 3, 0.1%). The prevalence of pandemic influenza A(H1N1) was 0.2% (N = 1) among arriving pilgrims and 0.1% (N = 2) among departing pilgrims. The prevalence of any respiratory virus infection was lower among those who said they received H1N1 vaccine compared to those who said they did not receive it (11.8% vs 15.6%, respectively, p = 0.009). Conclusion. We found very low pandemic influenza A(H1N1) prevalence among arriving pilgrims and no evidence that amplification of transmission had occurred among departing pilgrims. © 2011 International Society of Travel Medicine.

Revello M.G.,Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo | Lazzarotto T.,University of Bologna | Guerra B.,University of Bologna | Spinillo A.,Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo | And 13 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: Congenital infection with human cytomegalovirus (CMV) is a major cause of morbidity and mortality. In an uncontrolled study published in 2005, administration of CMV-specific hyperimmune globulin to pregnant women with primary CMV infection significantly reduced the rate of intrauterine transmission, from 40% to 16%. METHODS: We evaluated the efficacy of hyperimmune globulin in a phase 2, randomized, placebo-controlled, double-blind study. A total of 124 pregnant women with primary CMV infection at 5 to 26 weeks of gestation were randomly assigned within 6 weeks after the presumed onset of infection to receive hyperimmune globulin or placebo every 4 weeks until 36 weeks of gestation or until detection of CMV in amniotic fluid. The primary end point was congenital infection diagnosed at birth or by means of amniocentesis. RESULTS: A total of 123 women could be evaluated in the efficacy analysis (1 woman in the placebo group withdrew). The rate of congenital infection was 30% (18 fetuses or infants of 61 women) in the hyperimmune globulin group and 44% (27 fetuses or infants of 62 women) in the placebo group (a difference of 14 percentage points; 95% confidence interval, -3 to 31; P = 0.13). There was no significant difference between the two groups or, within each group, between the women who transmitted the virus and those who did not, with respect to levels of virus-specific antibodies, T-cell-mediated immune response, or viral DNA in the blood. The clinical outcome of congenital infection at birth was similar in the two groups. The number of obstetrical adverse events was higher in the hyperimmune globulin group than in the placebo group (13% vs. 2%). CONCLUSIONS: In this study involving 123 women who could be evaluated, treatment with hyperimmune globulin did not significantly modify the course of primary CMV infection during pregnancy. Copyright © 2014 Massachusetts Medical Society.

Gildea S.,Virology Unit | Arkins S.,University of Limerick | Walsh C.,Trinity College Dublin | Cullinane A.,Virology Unit
Vaccine | Year: 2011

Protection against equine influenza virus (EIV) relies largely on the production of circulating antibodies specific for the haemagglutinin (HA) glycoprotein. The objective of this study was to determine the antibody response of National Hunt horses in training to booster vaccination. The antibody response to the six equine influenza vaccines available in Ireland (three whole inactivated vaccines, two subunit vaccines and a canary pox recombinant vaccine), was monitored by single radial haemolysis (SRH) for six months post vaccination. There was no significant difference between antibody response induced following booster vaccination with any of the six vaccines. The antibodies peaked between two and four weeks post vaccination, decreased significantly by three months post vaccination and declined to their original levels by six months post vaccination. Peak antibody response to the canary pox recombinant vaccine was delayed in comparison to the other vaccines. Although analysis of the mean SRH levels of the horses suggested that they were clinically protected post booster vaccination, analysis of the individual responses suggested that there was potential for vaccination breakdown in a manner similar to that observed previously in racing yards in Ireland. There was a significant correlation between the SRH level at the time of vaccination and the antibody response. The findings of the study suggest that it would be advantageous to monitor SRH levels and to vaccinate strategically. The revaccination of horses with low antibody levels three months post booster vaccination may have been more effective in protecting horses in this yard than the annual vaccination of horses with high SRH levels. Eighteen of the 44 (41%) horses included in this study did not demonstrate a significant rise in SRH level to H3N8 following booster vaccination. It is presumed that annual revaccination is the minimum necessary to protect all horses against EI but this assumption needs to be systematically evaluated. It has been demonstrated that shorter intervals are required for optimum protection of young horses and it may be that longer vaccination intervals are sufficient for older horses with several years of vaccination history. Further investigations in a larger population of horses will be necessary to determine if the findings of this study are applicable to the population at large. © 2011 Elsevier Ltd.

Gildea S.,Virology Unit | Arkins S.,University of Limerick | Cullinane A.,Virology Unit
Influenza and other Respiratory Viruses | Year: 2010

Please cite this paper as: Gildea et al. (2010) A comparative antibody study of the potential susceptibility of Thoroughbred and non-Thoroughbred horse populations in Ireland to equine influenza virus. Influenza and Other Respiratory Viruses 4(6), 363-372. Background In Ireland, horses may be protected against equine influenza virus (EIV) as a result of natural exposure or vaccination. Current mandatory vaccination programmes are targeted at highly mobile horses. A correlation between antibody levels as measured by single radial haemolysis (SRH) and protective immunity against EIV has been established. Objectives The objective of this study was to determine the susceptibility of selected populations of horses by quantifying their antibodies to EIV. Methods Blood samples were collected from Thoroughbred weanlings, yearlings, racehorses and broodmares, teaser stallions and non-Thoroughbred horses. Antibodies against EIV H3N8 and H7N7 were measured by SRH. Results The order of susceptibility to Equine Influenza (EI) in the populations examined in Ireland was as follows: Thoroughbred weanlings>teasers>non-Thoroughbred horses and ponies>Thoroughbred yearlings>Thoroughbred horses in training>Thoroughbred broodmares. The H3N8 antibody levels of the weanlings, yearlings, broodmares and horses in training were similar to their H7N7 antibody levels, suggesting that their antibodies were primarily vaccinal in origin. The teasers and non-Thoroughbreds had higher H3N8 antibody levels than H7N7 antibody levels, suggesting that the majority of seropositive horses in these populations had been exposed to H3N8 by natural infection. Conclusions Weanlings, teasers and non-Thoroughbred horses were identified as most susceptible to EIV. The results suggest that it would be advisable that weanlings are vaccinated prior to attendance at public sales, that teaser stallions are vaccinated prior to each breeding season and that mandatory vaccination be implemented for participation in non-Thoroughbred events. © 2010 Blackwell Publishing Ltd.

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