4599 articles - 10.09.10
1: Vaccine. 2010 Sep 1; [Epub ahead of print]
Kung HC, Huang KC, Kao TM, Lee YC, Chang FY, Wang NC, Liu YC, Lee WS, Liu HJ, Chen CI, Chen CH, Huang LM, Hsieh SM.
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
We conducted a multi-center, randomized, laboratory-blinded clinical trial in 185 healthy adults (<60 years) and 107 elders (>60 years) to examine the immunogenicity and safety of different doses of an inactivated, monovalent, non-adjuvanted, split vaccine against the 2009 pandemic influenza A (H1N1) virus. The 186 adults were assigned to three treatment groups, i.e., one 15mug hemagglutination (HA) antigen dose, two 15mug or 30mug HA doses in 3 weeks apart, and the 107 elders were treated with two 15mug or 30mug doses in 3 weeks apart. Prior to the vaccination, 4.8% subjects had hemagglutination-inhibition (HAI) antibody titers of 1:40 or more. By day 21 post-vaccination of one dose of 15mug HA, the seroprotective rate was 95.1% and 75.5% in subjects <60 and >65 years of age, respectively; by day 21 post the second 15mug HA dose, the seroprotective rates were 93.2% and 73.1%, respectively. The seroprotective rates for recipients of 30mug HA antigen by day 21 were 95.2% for subjects <60 years and 81.1% for subjects >65 years of age, that was boosted to 98.3% and 80.4%, respectively with a second dose of 30mug HA antigen. No vaccine-related serious adverse events occurred. The data indicated a single 15mug HA dose of the vaccine induced a protective immune response in most adults, including the elders >60 years of age, and a booster dose at the third week did not render a higher level of antibody response. Copyright (c) 2010 Elsevier Ltd. All rights reserved.
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PMID: 20817013 [PubMed - as supplied by publisher]2: J Infect Dis. 2010 Sep 2; [Epub ahead of print]
Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia D, Cohn DL, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM.
Division of Infectious Diseases, Weill Cornell Medical College, 2Laser Surgery Care, 3Albert Einstein College of Medicine and 4Albert Einstein Cancer Center, Montefiore Medical Center, New York, New York; 5University of Arkansas for Medical Sciences, Little Rock; 6Boston University Medical Center, Boston, Massachusetts; 7University of California at San Francisco, San Francisco, 8University of California at Los Angeles, Los Angeles; 9Virginia Mason Medical Center and 10University of Washington, Seattle, Washington; 11Denver Public Health, University of Colorado Denver Health Sciences Center, Denver; and 12Merck Laboratories, Whitehouse Station, New Jersey.
Background. Human immunodeficiency virus type 1 (HIV-1)-infected men are at increased risk for anal cancer. Human papillomavirus (HPV) vaccination may prevent anal cancer caused by vaccine types. Methods. AIDS Malignancy Consortium Protocol 052 is a single-arm, open-label, multicenter clinical trial to assess the safety and immunogenicity of the quadrivalent HPV (types 6, 11, 16, and 18) vaccine in HIV-1-infected men. Men with high-grade anal intraepithelial neoplasia or anal cancer by history or by screening cytology or histology were excluded. Men received 0.5 mL intramuscularly at entry, week 8, and week 24. The primary end points were seroconversion to vaccine types at week 28, in men who were seronegative and without anal infection with the relevant HPV type at entry, and grade 3 or higher adverse events related to vaccination. Results. There were no grade 3 or greater adverse events attributable to vaccination among the 109 men who received at least 1 vaccine dose. Seroconversion was observed for all 4 types: type 6 (59 [98%] of 60), type 11 (67 [99%] of 68), type 16 (62 [100%] of 62), and type 18 (74 [95%] of 78). No adverse effects on CD4 counts and plasma HIV-1 RNA levels were observed. Conclusions. The quadrivalent HPV vaccine appears safe and highly immunogenic in HIV-1-infected men. Efficacy studies in HIV-1-infected men are warranted. Clinical trials registration. NCT 00513526 .
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PMID: 20812850 [PubMed - as supplied by publisher]3: Am J Trop Med Hyg. 2010 Sep;83(3):582-4.
Wang X, Hunter PR.
School of Medicine, Health Policy, and Practice, University of East Anglia, Norwich, UK. X.Wang@uea.ac.uk
The aim of this study was to identify whether there was a relationship between the distance that people have to carry water home and ill health. We conducted a systematic review for papers that reported on the association between diarrheal risk and distance. Six papers were identified for inclusion in the meta-analysis. These were all observational studies, and only two reported effect sizes that adjusted for possible confounding. Multiple different types of water sources supplied the study communities. The combined odds ratio (OR) showed a significant increase in illness risk in people living farther away from their water source (OR = 1.45; 95% confidence interval [CI] = 1.04-1.68). There is a need for better designed studies to further elucidate the health impacts on having to carry water home.
Publication Types: Research Support, Non-U.S. Gov't
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PMID: 20810824 [PubMed - in process]4: J Infect Dis. 2010 Oct 1;202(7):1114-25.
Crum-Cianflone NF, Huppler Hullsiek K, Roediger M, Ganesan A, Patel S, Landrum ML, Weintrob A, Agan BK, Medina S, Rahkola J, Hale BR, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group.
Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, National Naval Medical Center, Bethesda, Maryland 92134-1005, USA. nancy.crum@med.navy.mil
BACKGROUND: The risk of pneumococcal disease persists, and antibody responses to revaccination with the 23-valent polysaccharide vaccine (PPV) are low among human immunodeficiency virus (HIV)-infected adults. We determined whether revaccination with the 7-valent pneumococcal conjugate vaccine (PCV) would enhance these responses. METHODS: In a randomized clinical trial, we compared the immunogenicity of revaccination with PCV ( n = 131) or PPV (n = 73) among HIV-infected adults (median CD4 cell count, 533 cells/mm(3)) who had been vaccinated with PPV 3-8 years earlier. HIV-uninfected adults (n = 25) without prior pneumococcal vaccination received 1 dose of PCV. A positive response was defined as a >or=2-fold increase (from baseline to day 60) in capsule-specific immunoglobulin G, with a postvaccination level >or=1000 ng/mL for at least 2 of the 4 serotypes. RESULTS: HIV-infected persons demonstrated a higher frequency of positive antibody responses to PCV than to PPV (57% vs 36%) (P = .004) and greater mean changes in the immunoglobulin G concentration from baseline to day 60 for serotypes 4, 9V, and 19F (P < .05, for all), but not for serotype 14. However, by day 180, both outcomes were similar. Responses to PCV were greater in frequency and magnitude for all serotypes in HIV-uninfected adults, compared with those in HIV-infected adults. CONCLUSIONS: Among persons with HIV infection, revaccination with PCV was only transiently more immunogenic than PPV, and responses were inferior to those in HIV-uninfected subjects with primary vaccination. Pneumococcal vaccines with more robust and sustained immunogenicity are needed for HIV-infected adults. Clinical trial registration. ClinicalTrials.gov identifier NCT00622843.
Publication Types: Research Support, N.I.H., Extramural Research Support, U.S. Gov't, Non-P.H.S.
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PMID: 20795819 [PubMed - in process]5: Vaccine. 2010 Aug 20; [Epub ahead of print]
Keiser PB, Gibbs BT, Coster TS, Moran EE, Stoddard MB, Labrie JE 3rd, Schmiel DH, Pinto V, Chen P, Zollinger WD.
Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD, USA.
This phase 1 clinical trial assessed the safety and immunogenicity of a native outer membrane vesicle (NOMV) vaccine prepared from a lpxL2(-) synX(-) mutant of strain 44/76 with opcA expression stabilized. Thirty-four volunteers were assigned to one of the three dose groups (25mcg, 25mcg with aluminum hydroxide adjuvant, and 50mcg) to receive three intramuscular injections at 0, 6 and 24 weeks. Specific local and systemic adverse events (AEs) were solicited by diary and at visits on days 1, 2, 7 and 14 after each vaccination and at the end of the study at 30 weeks. Blood chemistries, complete blood count, and coagulation studies were measured on each vaccination day and again two days later. Blood for antibody measurements and bactericidal assays were drawn 0, 14, and 42 days after each vaccination. The proportion of volunteers who developed a fourfold or greater increase in serum bactericidal activity (SBA) to the wild-type parent of the vaccine strain with high opcA expression at 2 weeks after the third dose was 13/24 (0.54, 95% confidence interval 0.34-0.74). Antibody levels to OpcA were significantly higher in vaccine responders than in non-responders (p=0.008), and there was a trend for higher antibody levels to the lipooligosaccharide (LOS) (p=0.059). Bactericidal depletion assays on sera from volunteers with high-titer responses also indicate a major contribution of anti-OpcA and anti-LOS antibodies to the bactericidal response.These results suggest that genetically modified NOMV vaccines can induce protection against group B meningococcus. Copyright (c) 2010. Published by Elsevier Ltd.
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PMID: 20732470 [PubMed - as supplied by publisher]6: Pediatr Infect Dis J. 2010 Aug 18; [Epub ahead of print]
Diez-Domingo J, Flores SA, Martin JC, Klopfer SO, Schodel FP, Bhuyan PK.
From the *CSISP, Centro Superior de Investigacion en Salud Publica (Center for Public Health Research), Valencia, Spain; and daggerMerck & Co., Inc, West Point, PA.
This open-label, randomized study challenged 4- to 8-year-old children from Spain (N = 1478) with a single dose of hepatitis B vaccine to estimate anamnestic responses. At the time of preimmunization, 15.9% to 51.2% of subjects had antibody values >/=10 mIU/mL. One month postimmunization, 91.6% to 97.3% of subjects had antibody titers >/=10 mIU/mL. There were no serious, vaccine-related, adverse experiences, and no discontinuations as a result of adverse experience.
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PMID: 20724955 [PubMed - as supplied by publisher]7: Vaccine. 2010 Aug 16; [Epub ahead of print]
Kawakami K, Ohkusa Y, Kuroki R, Tanaka T, Koyama K, Harada Y, Iwanaga K, Yamaryo T, Oishi K.
Department of Respiratory Medicine, Nagasaki Kawatana Medical Center, Japan.
To determine the clinical efficacy and cost-saving effect of pneumococcal polysaccharide vaccine (PPV) against community-acquired pneumonia (CAP), an open-label, randomized clinical trial was conducted involving 786 Japanese subjects older than 65 years of age receiving a routine influenza vaccine during the 2-year period. Study subjects were randomly assigned to either a PPV group (n=394) or to a non-PPV group (n=392). The incidence, admission and the medical cost for all-cause pneumonia were compared between these two groups. PPV vaccination significantly reduced the incidence of admission for all-cause pneumonia for subjects older than 75 years of age (41.5%, P=0.039) and for those who had difficulty walking (62.7%, P=0.005), but not for all study subjects older than 65 years of age (P=0.183), for the 2-year period. The Kaplan-Meier survival curves for subjects who had difficulty walking free from all-cause pneumonia demonstrated a significant difference (P=0.0146) between the two groups. PPV vaccination significantly reduced medical costs for all study subjects during the first year period (P=0.027). Our present data demonstrated that PPV was effective for all-cause pneumonia for study subjects older than 75 years of age, although the effect was not significant for all study subjects older than 65 years of age. Copyright (c) 2010. Published by Elsevier Ltd.
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PMID: 20723631 [PubMed - as supplied by publisher]8: Vaccine. 2010 Aug 17; [Epub ahead of print]
Jacobsen KH, Wiersma ST.
Department of Global & Community Health, George Mason University, 4400 University Drive MS 5B7, Fairfax, VA 22030, USA.
OBJECTIVE: To estimate current age-specific rates of immunity to hepatitis A virus (HAV) in world regions by conducting a systematic review and meta-analysis of published data. The estimation of the global burden of hepatitis A and policies for public health control are dependent on an understanding of the changing epidemiology of this viral infection. METHODS: Age-specific IgG anti-HAV seroprevalence data from more than 500 published articles were pooled and used to fit estimated age-seroprevalence curves in 1990 and 2005 for each of 21 world regions (as defined by the Global Burden of Disease 2010 Study). FINDINGS: High-income regions (Western Europe, Australia, New Zealand, Canada, the United States, Japan, the Republic of Korea, and Singapore) have very low HAV endemicity levels and a high proportion of susceptible adults, low-income regions (sub-Saharan Africa and parts of South Asia) have high endemicity levels and almost no susceptible adolescents and adults, and most middle-income regions have a mix of intermediate and low endemicity levels. CONCLUSION: Anti-HAV prevalence estimates in this analysis suggest that middle-income regions in Asia, Latin America, Eastern Europe, and the Middle East currently have an intermediate or low level of endemicity. The countries in these regions may have an increasing burden of disease from hepatitis A, and may benefit from new or expanded vaccination programs. Copyright (c) 2010 Elsevier Ltd. All rights reserved.
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PMID: 20723630 [PubMed - as supplied by publisher]9: Vaccine. 2010 Aug 14; [Epub ahead of print]
Elbasha EH, Dasbach EJ.
Health Economic Statistics, Biostatistics and Research Decision Sciences, Merck Research Laboratories, Merck & Co., Inc., UG1C-60, PO Box 1000, North Wales, PA 19454-1099, United States.
We assessed the public health impact and value of vaccinating boys and men with the quadrivalent HPV vaccine in the United States. We used mathematical population models, accounting for both the direct and indirect protective effects of vaccination. Inputs for the models were obtained from public data sources, published literature, and analyses of clinical trial data. Compared with a program of vaccinating girls and women only, including boys and men 9-26 years of age would further decrease the cumulative mean number of genital wart cases, cervical intraepithelial neoplasia 2/3 cases, cancer cases, and cancer deaths by 5,146,000, 708,000, 116,000, and 40,000, respectively, within 100 years. The mean cost-effectiveness ratio (2008 US $) of this strategy was $25,700 (range: 13,600-48,800) per QALY gained if vaccination protects against all HPV 6/11/16/18-associated diseases, and $69,000 (range: 37,700-152,300)/QALY if it only protects against diseases currently in the vaccine indication. Vaccinating boys and men age 9-26 against all HPV 6/11/16/18-associated diseases provides substantial public health benefits and is cost-effective at commonly cited thresholds. Copyright (c) 2010 Elsevier Ltd. All rights reserved.
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PMID: 20713101 [PubMed - as supplied by publisher]10: Pediatr Infect Dis J. 2010 Aug 12; [Epub ahead of print]
Kalu SU, Ataya RS, McCormick DP, Patel JA, Revai K, Chonmaitree T.
From the Departments of *Pediatrics and daggerPathology, University of Texas Medical Branch at Galveston, Galveston, TX.
BACKGROUND:: Acute otitis media (AOM) often occurs as a complication of upper respiratory tract infection (URI). OBJECTIVE:: To describe otoscopic findings during URI, the full clinical spectrum of AOM, and outcome of cases managed with watchful waiting. METHODS:: In a prospective study of 294 healthy children (6 months-3 years), characteristics of AOM complicating URI were studied. Otoscopic findings were categorized by tympanic membrane (TM) position, color, translucency, and mobility. Otoscopic score was assigned based on McCormick otoscopy scale (OS)-8 scale. RESULTS:: During days 1 to 7 of URI, otoscopic findings at 1114 visits were consistent with AOM in 22%; myringitis (inflamed TM, no fluid) was diagnosed in 7%. In AOM episodes diagnosed within 28 days of URI onset, TM position was described as: nonbulging (19%), mild bulging (45%), bulging (29%), and TM perforation occurred in (6%). OS-8 scale showed mild TM inflammation (OS, 2-3) in 6%, moderate (OS, 4-5) in 59%, and severe (OS, 6-8) in 35%. In 54% of 126 bilateral AOM episodes, inflammation of both TMs was at different stages. Of 28 cases of nonsevere AOM managed with watchful waiting, 4 progressed and 3 later required an antibiotic. CONCLUSIONS:: AOM is a spectrum of infection that may present at various stages, even in the same child with bilateral disease. During URI, otoscopic changes are observed from the first day of onset. Understanding the wide clinical spectrum of AOM is needed to help with future clinical trial design and development of a scoring system to establish treatment criteria that will minimize antibiotic use.
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PMID: 20711085 [PubMed - as supplied by publisher]11: Sex Transm Dis. 2010 Aug 12; [Epub ahead of print]
Biraro S, Mayaud P, Morrow RA, Grosskurth H, Weiss HA.
From the *Medical Research Council (MRC)/Uganda Virus Research Institute (UVRI) Uganda Research Unit on AIDS, Entebbe, Uganda; daggerMRC Tropical Epidemiology Group, Infectious Disease Epidemiology Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom; double daggerClinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom; and section signDepartment of Laboratory Medicine, University of Washington, Seattle, WA.
BACKGROUND:: Several commercial type-specific serologic tests are available for herpes simplex virus type 2 (HSV-2). Poor specificity of some tests has been reported on samples from sub-Saharan Africa. METHODS:: To summarize the performance of the tests using samples from sub-Saharan Africa, we conducted a systematic review of publications reporting performance of commercially available HSV-2 tests against a gold standard (Western Blot or monoclonal antibody-blocking EIA). We used random-effects meta-analyses to summarize sensitivity and specificity of the 2 most commonly evaluated tests, Kalon gG2 enzyme-linked immunosorbent assay (ELISA), and Focus HerpeSelect HSV-2 ELISA. RESULTS:: We identified 10 eligible articles that included 21 studies of the performance of Focus, and 12 of Kalon. The primary analyses included studies using the manufacturers' cut-offs (index value = 1.1). Focus had high sensitivity (random effects summary estimate 99%, 95% confidence interval [CI]: 99%-100%) but low specificity (69%, 95% CI: 59%-80%). Kalon had sensitivity of 95% (95% CI: 93%-97%) and specificity of 91% (95% CI: 86%-95%). Specificity of Focus was significantly lower (P = 0.002) among HIV-positive (54%, 95% CI: 40%-68%) than HIV-negative individuals (69%, 95% CI: 56%-82%). When the cut-off optical density index was increased above the recommended value of 1.1 to between 2.2 and 3.5, the specificity of Focus increased to 85% (95% CI: 77%-92%). CONCLUSIONS:: Sensitivity and specificity of HSV-2 tests used in sub-Saharan Africa vary by setting, and are lower than reported from studies in the United States and Europe. Increasing the cut-off optical density index may improve test performance. Evaluation of test performance in a given setting may help deciding which test is most appropriate.
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PMID: 20706175 [PubMed - as supplied by publisher]12: J Infect Dis. 2010 Sep 1;202 Suppl:S93-100.
Steele AD, Reynders J, Scholtz F, Bos P, de Beer MC, Tumbo J, Van der Merwe CF, Delem A, De Vos B.
MRC Diarrhoeal Pathogens Research Unit, University of Limpopo, Pretoria, Republic of South Africa. dsteele@path.org
BACKGROUND: A phase II, randomized, double-blind, placebo-controlled study was conducted in South Africa during 2003-2004 to evaluate the safety, reactogenicity, and immunogenicity of 2 regimens of the live attenuated oral human rotavirus vaccine RIX4414 when coadministered with the Expanded Program on Immunization childhood vaccines, including oral polio vaccine. METHODS: Healthy infants were randomized (2:2:1) to receive either 2 doses of RIX4414 (n = 190; at 10 and 14 weeks, with placebo at 6 weeks), 3 doses of RIX4414 (n = 189; at 6, 10, and 14 weeks), or 3 doses of placebo (n = 96), all with concomitant routine vaccinations. The antirotavirus IgA seroconversion rate was assessed using enzyme-linked immunosorbent assay at 2 months after the last dose of RIX4414 or placebo. Antipolio types 1, 2, and 3 antibodies were measured using a virus neutralization assay. Solicited symptoms were recorded for 15 days after each dose. RESULTS: The antirotavirus IgA seroconversion rates were similar in the RIX4414 2- and 3-dose groups (44.3% and 44.4%, respectively; P = .544, by 1-sided Fisher exact test) and antirotavirus IgA geometric mean concentrations were also comparable. Seroprotection rates for antipolio types 1, 2, and 3 antibodies were high (93%-100%) and were not significantly different among groups. Solicited symptoms reported within 15 days after vaccination were similar in all groups. CONCLUSIONS: The immune seroconversion response to the RIX4414 vaccine with 3 doses was not superior to the 2-dose regimen. There was no interference by either regimen with antibody response to oral polio vaccine, and RIX4414 was well tolerated when given with routine vaccinations.
Publication Types: Clinical Trial, Phase II Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
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PMID: 20684724 [PubMed - indexed for MEDLINE]13: J Infect Dis. 2010 Sep 1;202 Suppl:S12-22.
Malek MA, Teleb N, Abu-Elyazeed R, Riddle MS, Sherif ME, Steele AD, Glass RI, Bresee JS.
Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. mmalek@cdc.gov
OBJECTIVE: Rotavirus is the leading cause of severe diarrhea among children worldwide, killing approximately 600,000 children annually, including 64,800 in the Eastern Mediterranean Region. Safe, effective rotavirus vaccines will be available soon, and accurate disease burden data will be needed to assess the burden of rotavirus and the value of new vaccines and monitor vaccine program impact. METHODS: To identify epidemiologic studies in which rotavirus diagnostics were applied to children with acute gastroenteritis, we performed a systematic literature review. We selected studies that met 4 criteria and extracted rotavirus data on prevalence estimates, strain identification, age distribution of patients, and seasonal trends. RESULTS: Of the 63 published studies with some rotavirus detection data, 29 met inclusion criteria. Among patients with diarrhea, rotavirus was detected in 40% of inpatients and 23% of outpatients. By 3 years of age, 75% of children experienced a documented rotavirus infection. Circulation of rotavirus occurred year-round, and no clear relationship between the timing of the rotavirus peak with either season or latitude was observed. Comparison of country-specific rotavirus detection rates indicated that the proportion of hospitalizations for rotavirus infection increased with income. CONCLUSION: This systematic review of studies of rotavirus diarrhea among children in the countries of the Eastern Mediterranean Region documents that rotavirus is one of the most significant causes of childhood diarrhea in the region. The findings of this review will be used to establish sentinel hospital surveillance in these countries, estimate disease burden, and characterize its epidemiology using common protocols and diagnostics.
Publication Types: Review
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PMID: 20684691 [PubMed - indexed for MEDLINE]14: Vaccine. 2010 Aug 3; [Epub ahead of print]
Nascimento E, Fernandes DF, Vieira EP, Campos-Neto A, Ashman JA, Alves FP, Coler RN, Bogatzki LY, Kahn SJ, Beckmann AM, Pine SO, Cowgill KD, Reed SG, Piazza FM.
Universidade Federal de Minas Gerais e Centro de Ensino e Pesquisa do Hospital Santa Casa de Belo Horizonte, MG, Brazil; Ambulatorio de Leishmaniose, Hospital Municipal de Januaria, MG, Brazil.
Forty-four adult patients with cutaneous leishmaniasis (CL) were enrolled in a randomized, double-blind, controlled, dose-escalating clinical trial and were randomly assigned to receive three injections of either the LEISH-F1+MPL-SE vaccine (consisting of 5, 10, or 20mug recombinant Leishmania polyprotein LEISH-F1 antigen+25mug MPL((R))-SE adjuvant) (n=27), adjuvant alone (n=8), or saline placebo (n=9). The study injections were given subcutaneously on Days 0, 28, and 56, and the patients were followed through Day 336 for safety, immunological, and clinical evolution endpoints. All patients received chemotherapy with meglumine antimoniate starting on Day 0. The vaccine was safe and well tolerated. Nearly all vaccine recipients and no adjuvant-alone or placebo recipients demonstrated an IgG antibody response to LEISH-F1 at Day 84. Also at Day 84, 80% of vaccine recipients were clinically cured, compared to 50% and 38% of adjuvant-alone and placebo recipients. The LEISH-F1+MPL-SE vaccine was safe and immunogenic in CL patients and appeared to shorten their time to cure when used in combination with meglumine antimoniate chemotherapy. Copyright (c) 2010 Elsevier Ltd. All rights reserved.
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PMID: 20688040 [PubMed - as supplied by publisher]15: Pediatr Infect Dis J. 2010 Jul 30; [Epub ahead of print]
Chandran A, Herbert H, Misurski D, Santosham M.
From the *Department of International Health, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD; and daggerGlaxoSmithKline, Global health Outcomes Vaccines, Philadelphia, PA.
BACKGROUND:: Numerous sequelae have been noted in survivors of bacterial meningitis; however, few studies document sequelae for several years following a childhood episode of bacterial meningitis. In addition, studies generally focus on the more commonly found sequelae. To review the known information and highlight this gap, this article presents a comprehensive literature review of the long-term (>/=5 years of follow-up) sequelae of childhood bacterial meningitis. METHODS:: A systematic literature search was conducted between December 2009 and February 2010. English-language articles published between January 1970 and January 2010 were selected for screening. Articles were included if the subjects were between the ages of 1 month and <18 years at the time of diagnoses of meningitis. RESULTS:: A total of 1433 children who were survivors of childhood bacterial meningitis were evaluated for sequelae after the time of discharge. Of these children, 705 (49.2%) were reported to have 1 or more long-term sequelae. A majority of reported sequelae were behavioral and/or intellectual disorders (n = 455, 45.0%). Hearing changes accounted for 6.7% (n = 68) of sequelae and gross neurologic deficits accounted for 14.3% (n = 145). DISCUSSION:: A majority of childhood bacterial meningitis survivors with long-term sequelae that are documented in the literature have academic and behavioral limitations. While neurologic deficits may resolve over time, subtle behavioral deficits may not be appreciated initially and may continue to affect survivors for many years. Further studies are needed to quantify the true societal and economic burden of long-term sequelae as well as fully understand the breadth of types of sequelae that survivors experience.
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PMID: 20683377 [PubMed - as supplied by publisher]16: Am J Trop Med Hyg. 2010 Aug;83(2):351-6.
Velez I, Lopez L, Sanchez X, Mestra L, Rojas C, Rodriguez E.
Universidad de Antioquia, Medellin, Colombia. idvelez@pecet-colombia.org
Miltefosine is an oral agent used for cutaneous leishmaniasis treatment. An open-label, randomized, phase III clinical trial was carried out in the Colombian army population. Miltefosine, 50 mg capsule was taken orally three times per day for 28 days (N = 145) or meglumine antimoniate, 20 mg/kg body weight per day for 20 days by intramuscular injection (N = 143). The efficacy of miltefosine by protocol was 69.8% (85/122 patients) and 58.6% (85/145 patients) by intention to treat. For meglumine antimoniate, the efficacy by protocol was 85.1% (103/121 patients) and 72% (103/143 patients) by intention to treat. No association was found between drug efficacy and L. (V.) braziliensis or L. (V.) panamensis species of Leishmania responsible for infection. Adverse gastrointestinal events were associated with the use of miltefosine, the meglumine antimoniate treatment was associated with adverse effects on the skeletal musculature, fever, cephalea, and higher toxicity in kidney, liver, pancreas, and hematological system.
Publication Types: Clinical Trial, Phase III Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
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PMID: 20682881 [PubMed - indexed for MEDLINE]17: J Infect Dis. 2010 Sep 15;202(6):862-6.
Ray R, Meyer K, Banerjee A, Basu A, Coates S, Abrignani S, Houghton M, Frey SE, Belshe RB.
Department of Internal Medicine and Vaccine and Treatment Evaluation Unit, Saint Louis University, St. Louis, Missouri, USA. rayr@slu.edu
Hepatitis C virus (HCV) envelope glycoproteins E1 and E2 were used with MF59 adjuvant as a candidate vaccine for a phase 1 safety and immunogenicity trial. Ten of 41 vaccinee serum samples displayed a neutralization titer of > or =1:20 against vesicular stomatitis virus (VSV)-HCV pseudotype, 15 of 36 serum samples tested had a neutralization titer of > or =1:400 against human immunodeficiency virus (HIV)-HCV pseudotype, and 10 of 36 serum samples tested had a neutralization titer of > or =1:20 against cell culture-grown HCV genotype 1a. Neutralizing serum samples had increased affinity levels and displayed >2-fold higher specific activity levels to well-characterized epitopes on E1/E2, especially to the hypervariable region 1 of E2.
Publication Types: Clinical Trial, Phase I Research Support, N.I.H., Extramural
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20677942&dopt=ExternalLink
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PMID: 20677942 [PubMed - indexed for MEDLINE]18: Vaccine. 2010 Aug 31;28(38):6137-44. Epub 2010 Jul 29.
Esposito S, Marchisio P, Ansaldi F, Bianchini S, Pacei M, Baggi E, Trabattoni D, Icardi G, Principi N.
Department of Maternal and Pediatric Sciences, Universita degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Commenda 9, 20122 Milan, Italy.
This study evaluated the immunogenicity of a double dose of the seasonal virosomal-adjuvanted influenza vaccine (Inflexal V, Crucell, The Netherlands) in 65 previously unvaccinated children aged less than 3 years: 43 received double doses (two doses of 0.50 mL 4 weeks apart) and 22 standard doses (two doses of 0.25 mL 4 weeks apart). Both treatments evoked a response that satisfied the EMEA criteria for adequate immunogenicity for all three vaccine strains, but the double dose had a significantly greater effect on all of the studied parameters of humoral and cell-mediated immune response (p<0.05). This result was achieved without any increase in the incidence of local and systemic adverse events. This means that doubling the dose of the virosomal-adjuvanted influenza vaccine (i.e. administering the same dose as that usually given to older children) effectively and safely increases the immune response to inactivated influenza vaccine in unprimed children aged less than 3 years. (c) 2010 Elsevier Ltd. All rights reserved.
Publication Types: Research Support, Non-U.S. Gov't
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20670909&dopt=ExternalLink
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PMID: 20670909 [PubMed - in process]19: Vaccine. 2010 Aug 31;28(38):6159-63. Epub 2010 Jul 24.
Kao TM, Hsieh SM, Kung HC, Lee YC, Huang KC, Huang LM, Chang FY, Wang NC, Liu YC, Lee WS, Liu HE, Chen CI, Chen CH.
Department of Internal Medicine, National Taiwan University Hospital, Medical College of National Taiwan University, Taipei, Taiwan.
We conducted a multi-center, randomized and laboratory-blinded clinical trial with subgroup analyses, involving adults aged greater than 60 years old (range 61-86 years old), to investigate the immunogenicity and the potential factors affecting the immune response of a monovalent, unadjuvanted, inactivated, split-virus vaccine. A total of 107 subjects were randomized to receive 15 and 30 microg of hemagglutinin antigen in a 1:1 ratio. The immunogenicity was detected through hemagglutination inhibition (HAI) test of serum obtained before and 3 weeks after vaccination. By 3 weeks after vaccination, HAI titer >or=1:40 was observed in 75.5% and 81.1% of participants receiving 15 and 30 microg of hemagglutinin antigen, respectively. Positive seroconversion was observed in 71.7% and 81.1% of recipients of the 15 and the 30 microg, respectively. The GMTs increased by a factor of 10.7 and 17.4 in the groups of 15 and 30 microg, respectively. This study indicated that one dose of 15 microg hemagglutinin antigen without adjuvant induced protective immune response in the majority of elderly. Multivariate logistic regression analyses showed that gender, age and diabetes were statistically significant factors affecting the seroprotection rate (p=0.04, 0.01 and 0.01, respectively) and seroconversion rate (p=0.01, 0.01 and 0.01, respectively). (c) 2010 Elsevier Ltd. All rights reserved.
Publication Types: Research Support, Non-U.S. Gov't
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20659517&dopt=ExternalLink
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PMID: 20659517 [PubMed - in process]20: Vaccine. 2010 Aug 31;28(38):6128-36. Epub 2010 Jul 23.
O'Loughlin RE, Edmond K, Mangtani P, Cohen AL, Shetty S, Hajjeh R, Mulholland K.
London School of Hygiene and Tropical Medicine, London, UK. rosoloughlin@gmail.com
The use of the highly effective Haemophilus influenzae type b (Hib) conjugate vaccine has increased globally. We review the benefits and limitations of studies measuring Hib vaccine effectiveness (VE). We critically examine the case-control approach by assessing the similarities and differences in methodology and findings and discuss the need for future Hib VE studies. In the absence of good surveillance data, vaccine effectiveness studies can play an important role, particularly with the increasing use of pneumococcal vaccine that has not been well tested under field conditions in less developed countries. However, the effectiveness of Hib vaccine has been well documented so the need for future VE Hib studies is minimal. (c) 2010 Elsevier Ltd. All rights reserved.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20655402&dopt=ExternalLink
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PMID: 20655402 [PubMed - in process]