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    <recommendedItem id="20100101_19_432"
                     title="Short Needle May Short HBV Protection for Obese (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/Pediatrics/Vaccines/tb/18348?impressionId=1265800465286"
                     
      &lt;p&gt;Obese adolescents and young adults may not generate an adequate immune response to hepatitis B (HBV) vaccine because the needles used to vaccinate them are too short, a randomized study suggests.&lt;/p&gt;
&lt;p&gt;Immunization with a 1.5-inch needle was associated with 80% higher anti-HBV titers than a 1.0-inch needle, researchers reported online in &lt;em&gt;Pediatrics.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;The difference persisted in analyses performed to correct for imbalances in the study population.&lt;/p&gt;
&lt;p&gt;&quot;This supports the hypothesis that inadequate muscle penetration is responsible, at least in part, for lower immune response to HBV vaccine among obese adolescent and adult vaccine recipients,&quot; Amy Middleman, MD, of Baylor College of Medicine in Houston, and colleagues concluded.&lt;/p&gt;
&lt;p&gt;Several studies have shown that adolescents and adults with a higher body mass index (BMI) have lower antibody titers after HBV vaccination. The observations have taken on new significance, given that an increasing number of vaccines target a population that has a rising BMI, the authors wrote.&lt;/p&gt;
&lt;p&gt;Researchers hypothesize that standard-length needles do not penetrate through the deltoid fat and into the muscle of obese adolescents and adults. Because of its less abundant blood supply, adipose tissue may delay antigen presentation to B and T cells responsible for immune response, the authors continued.&lt;/p&gt;
&lt;p&gt;To test the hypothesis, Middleman and colleagues conducted a randomized, clinical trial involving adolescents and adults ages 14 to 24 with no prior exposure to HBV vaccine. Eligibility criteria included weight &amp;gt;90 kg for female patients and &amp;gt;120 kg for male patients.&lt;/p&gt;
&lt;p&gt;Patients were randomized to receive the HBV vaccine series with a standard one-inch needle or a 1.5-inch needle. Patients younger than 19 received 0.5-mL injections, and older patients received 1.0-mL injections.&lt;/p&gt;
&lt;p&gt;Investigators used a standardized injection procedure: insertion of the needle at a 90&amp;#176; angle to the deltoid muscle, leaving 2 to 3 mm of needle visible between the skin and the hub.&lt;/p&gt;
&lt;p&gt;Patients received three doses of vaccine at baseline, one month, and four months. Blood samples were obtained at baseline and two months after the final injection.&lt;/p&gt;
&lt;p&gt;The two groups did not differ significantly with respect to median age (21), BMI (~40), deltoid skinfold (41 mm), triceps skinfold (~40 mm), days between vaccine doses one and three (~135), and days from third vaccine dose to titer assessment (65).&lt;/p&gt;
&lt;p&gt;At the end of the study, 24 patients had completed the immunization protocol, 10 in the one-inch group and 14 in the 1.5-inch group.&lt;/p&gt;
&lt;p&gt;Patients vaccinated with a one-inch needle had a median antibody titer of 189.8 mIU/mL compared with 345.4 mIU/mL for patients vaccinated with the 1.5-inch needle (&lt;em&gt;P&lt;/em&gt;=0.03).&lt;/p&gt;
&lt;p&gt;The between-group difference remained significant in analyses that excluded an outlier from the 1.5-inch group (&lt;em&gt;P&lt;/em&gt;=0.047) and that excluded the only two male patients in the study (&lt;em&gt;P&lt;/em&gt;=0.035).&lt;/p&gt;
&lt;p&gt;&quot;As we continue to experience high rates of obesity in the U.S. and throughout the world, additional evidence-based research on optimizing the effective delivery of immunizations to adolescents and young adults will be critical,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;Following updated needle length recommendations will be a first step toward improving the health of our youth and young adults by preventing vaccine-preventable diseases.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by federal grants and awards. GlaxoSmithKline provided the vaccine.&lt;/p&gt;&lt;p&gt;The authors had no disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_349"
                     title="Motavizumab Reduces Preemie Lung Infections (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/Pediatrics/Vaccines/tb/18232?impressionId=1265800465286"
                     
      &lt;p&gt;Premature babies who received preventative treatment with motavizumab (Medi-524) suffered fewer outpatient respiratory infections than those taking palivizumab (Synagis), the current standard of treatment, a large new trial found.&lt;/p&gt;
&lt;p&gt;Compared with children who received palivizumab, those treated with motavizumab had similar rates of hospitalization for respiratory syncytial virus, or RSV (RR 0.74; 95% CI 0.503 to 1.083) and a 50% reduction in outpatient, RSV-specific, medically attended lower respiratory tract infection, or MALRI (2.0% vs 3.9%; &lt;em&gt;P&lt;/em&gt;=0.005), according to a report in the January issue of &lt;em&gt;Pediatrics&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;&quot;Although not better than palivizumab in reducing RSV-associated hospitalizations, motavizumab did demonstrate a significant reduction in outpatient MALRI compared with palivizumab,&quot; Xavier Carbonell-Estrany, MD, PhD, of Hospital Cl&amp;#237;nic, in Barcelona, Spain, and colleagues wrote.&lt;/p&gt;
&lt;p&gt;&quot;As such, motavizumab may offer an improved alternative for preventing serious RSV disease in high-risk infants and children.&quot;&lt;/p&gt;
&lt;p&gt;Most otherwise healthy patients recover within a week or two from RSV, which infects the lungs and breathing passages. However, the infection can be severe in people who are vulnerable, including premature infants and older children who were born prematurely. It&apos;s the most common cause of bronchiolitis and pneumonia in U.S. children in their first year of life, researchers noted.&lt;/p&gt;
&lt;p&gt;Palivizumab is a humanized monoclonal antibody recommended for prevention of RSV in children at high risk. Monthly treatments of high-risk youngsters have been found to reduce RSV-related hospitalizations by 50%, compared with placebo.&lt;/p&gt;
&lt;p&gt;Motavizumab, an investigational monoclonal antibody related to palivizumab, proved more potent at neutralizing the RSV virus in animal studies. Early trials indicated the drug was well-tolerated at treatment doses and reduced viral counts in the nasal aspirates of children hospitalized with RSV.&lt;/p&gt;
&lt;p&gt;Both drugs are manufactured by MedImmune, the sponsor of this phase III clinical trial.&lt;/p&gt;
&lt;p&gt;In the double-blind, multinational study, Carbonell-Estrany and colleagues randomly assembled 6,635 preterm infants (6 months and younger) and children (2 years and younger) suffering from chronic lung disease resulting from premature birth.&lt;/p&gt;
&lt;p&gt;They were randomized to five 15 mg/kg monthly doses of palivizumab or motavizumab between November 2004 and May 2006. The trial was conducted in 24 countries.&lt;/p&gt;
&lt;p&gt;The primary objective was to compare the efficacy of the two drugs at preventing a child from being hospitalized due to respiratory symptoms from an RSV infection, preventing a child already hospitalized from contracting a new infection, and preventing deaths from RSV.&lt;/p&gt;
&lt;p&gt;Of the 6,513 children who received full treatment with the drugs, 43 (1.4%) of those who received motavizumab and 59 (1.9%) of those who received palivizumab were hospitalized for RSV infections (95% CI 0.490 to 1.081).&lt;/p&gt;
&lt;p&gt;The study also compared the drugs&apos; efficacy at preventing RSV-specific outpatient MALRIs. Of the 2,283 outpatients who received full treatment with the drugs, 23 (2%) who received motavizumab and 45 (3.9%) who received palivizumab contracted RSV infections (&lt;em&gt;P&lt;/em&gt;=0.005).&lt;/p&gt;
&lt;p&gt;The authors noted that while the drugs had similar overall safety profiles, participants who took motavizumab had more cutaneous reactions.&lt;/p&gt;
&lt;p&gt;&quot;In this large, multinational, well controlled trial, motavizumab was shown to be noninferior to palivizumab for prevention of RSV hospitalization (primary end point) and was superior to palivizumab for reduction of RSV-specific outpatient MALRI (a secondary end point),&quot; the authors wrote.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was funded by MedImmune, the manufacturer of motavizumab.&lt;/p&gt;&lt;p&gt;Several of the authors reported being employees of MedImmune or receiving consulting and research services fees from MedImmune and Abbott International.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_310"
                     title="Rotavirus Vaccine Effective in Third World Nations (CME/CE)"
                     score="0.004"
                     href="http://www.medpagetoday.com/Pediatrics/Vaccines/tb/18174?impressionId=1265800465286"
                     
      &lt;p&gt;Vaccination against rotavirus appears to be highly effective in reducing death and serious gastrointestinal disease among young children in developing countries, according to two&lt;strong&gt; &lt;/strong&gt;publications in the Jan. 28 &lt;em&gt;New England Journal of Medicine.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;In Malawi and South Africa, a vaccination program significantly reduced infantile gastroenteritis associated with the pathogen, researchers said.&lt;/p&gt;
&lt;p&gt;In a companion paper, investigators reported that a rotavirus vaccination program in Mexico appears to have been the cause of a marked reduction in deaths from diarrhea among young children.&lt;/p&gt;
&lt;p&gt;Taken together, the two studies suggest that physicians have &quot;another powerful weapon&quot; to help prevent death from diarrhea among young children, according to Mathuram Santosham, MD, of the Johns Hopkins Bloomberg School of Public Health, who was not involved in the research.&lt;/p&gt;
&lt;p&gt;&quot;It is time to act to combat the 1.8 million unnecessary deaths from diarrhea that continue to occur each year,&quot; Santosham wrote in an accompanying editorial.&lt;/p&gt;
&lt;p&gt;Two oral, live attenuated vaccines against rotavirus have been shown to prevent the associated gastroenteritis  --  GlaxoSmithKline&apos;s Rotarix and Merck&apos;s RotaTeq, according to Nigel Cunliffe, MBChB, PhD, of the University of Liverpool in England, and colleagues.&lt;/p&gt;
&lt;p&gt;But trials of those drugs mainly occurred in more developed countries, the researchers noted, so the World Health Organization  --  fearing they might not work as well among the very poor  --  suggested additional trials in the Third World.&lt;/p&gt;
&lt;p&gt;To fill the knowledge gap, Cunliffe and colleagues conducted a randomized, placebo-controlled trial in Malawi and South Africa, enrolling 4,939 healthy infants.&lt;/p&gt;
&lt;p&gt;They were assigned to get either three doses of placebo (at six, 10, and 14 weeks of age), two doses of the Rotarix vaccine and one of placebo to maintain blinding, or three doses of the vaccine.&lt;/p&gt;
&lt;p&gt;The researchers found: &lt;ul&gt; &lt;li&gt;Severe gastroenteritis caused by rotavirus occurred in 4.9% of the placebo group and in 1.9% of the pooled vaccine group, yielding a vaccine efficacy of 61.2%, which was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001. &lt;/li&gt; &lt;li&gt;Vaccine efficacy was lower in Malawi than in South Africa  --  49.4% versus 76.9%. But the vaccine prevented more cases of severe rotavirus gastroenteritis in Malawi  --  6.7 cases prevented per 100 infants vaccinated yearly versus 4.2.&lt;/li&gt; &lt;li&gt;Efficacy against all-cause severe gastroenteritis was 30.2%.&lt;/li&gt; &lt;li&gt;At least one serious adverse event was reported in 9.7% of the vaccinated infants and 11.5% of the placebo group, but only three were judged to be related to the vaccine.&lt;/li&gt; &lt;li&gt;There was a single case of intussusception -- a 6-month-old child in the three-dose vaccine group, who recovered after bowel resection.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The findings have led WHO to recommend that rotavirus vaccination be included in all national immunization programs, Cunliffe and colleagues noted.&lt;/p&gt;
&lt;p&gt;Mexico phased in rotavirus vaccination over slightly more than a year, from February 2006 through May 2007, according to Manish Patel, MD, of the CDC, and colleagues.&lt;/p&gt;
&lt;p&gt;To estimate the effect of the program, Patel and colleagues compared annual deaths from diarrhea before and after the immunization program began.&lt;/p&gt;
&lt;p&gt;Over the four years before the program started, the median annual number of diarrhea-related deaths among children younger than five was 1,793, the researchers found, for a mortality rate of 18.1 deaths per 100,000.&lt;/p&gt;
&lt;p&gt;In 2008, by contrast, there were 1,118 deaths, a reduction of 765, which yielded a mortality rate of 11.8 per 100,000 children, they reported in the journal.&lt;/p&gt;
&lt;p&gt;The rate reduction of 35% was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001, Patel and colleagues said.&lt;/p&gt;
&lt;p&gt;The findings come with some caveats, the researchers said. Among them: &lt;ul&gt; &lt;li&gt;It was not possible to pin down the reduction in deaths attributable to vaccination because precise vaccine coverage information is lacking. &lt;/li&gt; &lt;li&gt;Other changes, such as hygiene improvements, might also have affected the trend.&lt;/li&gt; &lt;li&gt;Because of difficulty obtaining fecal specimens, it wasn&apos;t possible to study trends in rotavirus deaths specifically.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;While the studies suggests that rotavirus vaccination would prevent much disease and many deaths, there are obstacles to introducing the vaccine to poorer countries, Santosham noted in the editorial.&lt;/p&gt;
&lt;p&gt;A key obstacle, he said, is that the vaccine requires more refrigeration  --  so-called &quot;cold-chain&quot; storage  --  than typical childhood vaccines.&lt;/p&gt;
&lt;p&gt;Also problematic, he said, is the current recommendation that the vaccines be given early in life to avoid age-dependent occurrence of intussusception, which led to an earlier vaccine being taken off the market.&lt;/p&gt;
&lt;p&gt;In many of the poorest countries, on-time vaccination is rare, which may impede the use of a rotavirus vaccine unless the time window for administration can be opened wider, he said.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The African study was supported by GlaxoSmithKline and the PATH Rotavirus Vaccine Program, a collaboration with the World Health Organization and the CDC with support from the Global Alliance for Vaccines and Immunization (GAVI). Cunliffe reported financial links with Sanofi Pasteur and GlaxoSmithKline.&lt;/p&gt;&lt;p&gt;For the Mexican study, the researchers did not report any external support or any conflicts.&lt;/p&gt;&lt;p&gt;Santosham reported financial links with GlaxoSmithKline and Merck, both of which make rotavirus vaccines.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_1_130"
                     title="Statins Appear to Reduce Risk of Sepsis"
                     score="-0.006"
                     href="