Comparison of two clinical severity scoring systems in two multi-center, developing country rotavirus vaccine trials in Africa and Asia.

Background: Clinical severity scoring systems are used in rotavirus vaccine efficacy and effectiveness studies to define the primary endpoint, severe rotavirus gastroenteritis (RVGE). Understanding how scoring systems perform in diverse settings is critical for proper design and interpretation. This investigation aims to understand how the Vesikari scoring system (VSS) and Clark scoring system (CSS) categorize severe disease among children under 2 years of age using data from two Phase III efficacy trials conducted in five developing countries in Africa and Asia.

Molecular characterization of rotavirus strains detected during a clinical trial of a human rotavirus vaccine in Blantyre, Malawi.

The human, G1P[8] rotavirus vaccine (Rotarix™) significantly reduced severe rotavirus gastroenteritis episodes in a clinical trial in South Africa and Malawi, but vaccine efficacy was lower in Malawi (49.5%) than reported in South Africa (76.9%) and elsewhere.

Immunogenicity of the pentavalent rotavirus vaccine among infants in two developing countries in Asia, Bangladesh and Vietnam.

Background: We evaluated the immunogenicity of the pentavalent rotavirus vaccine (PRV) in two GAVI-eligible Asian countries, Bangladesh and Vietnam, nested in a larger randomized, double-blind, placebo-controlled efficacy trial conducted over a two-year period from 2007 through 2009.

Methods: 2036 infants were randomly assigned, in a 1:1 ratio, to receive three oral doses of PRV or placebo approximately at 6, 10, and 14 weeks of age. Concomitant use of EPI vaccines, including oral poliovirus vaccine (OPV) and diphtheria-tetanus-whole cell pertussis (DTwP) vaccine, was encouraged in accordance to the local EPI schedule.

Expanding the recommendations for annual influenza vaccination to school-age children in the United States.

Background: Despite long-standing recommendations to vaccinate children who have underlying chronic medical conditions or who are contacts of high-risk persons, vaccination coverage among school-age children remains low. Community studies have indicated that school-age children have the highest incidence of influenza and are an important source of amplifying and sustaining community transmission that affects all age groups.

Methods: A consultation to discuss the advantages and disadvantages of a universal recommendation for annual influenza vaccination of all children age ≥6 months was held in Atlanta, Georgia, in September 2007.

Monitoring influenza activity in the United States: a comparison of traditional surveillance systems with Google Flu Trends.

Background: Google Flu Trends was developed to estimate US influenza-like illness (ILI) rates from internet searches; however ILI does not necessarily correlate with actual influenza virus infections.

Methods And Findings: Influenza activity data from 2003-04 through 2007-08 were obtained from three US surveillance systems: Google Flu Trends, CDC Outpatient ILI Surveillance Network (CDC ILI Surveillance), and US Influenza Virologic Surveillance System (CDC Virus Surveillance). Pearson's correlation coefficients with 95% confidence intervals (95% CI) were calculated to compare surveillance data.

Influenza vaccine for pregnant women in resource-constrained countries: a review of the evidence to inform policy decisions.

Seasonal influenza is responsible for three to five million severe cases of disease annually, and up to 500,000 deaths worldwide. Pregnant women and infants suffer disproportionately from severe outcomes of influenza. The excellent safety profile and reliable immunogenicity of inactivated influenza vaccine support WHO recommendations that pregnant women be vaccinated to decrease complications of influenza disease during pregnancy.

Outpatient upper respiratory tract viral infections in children with malaria symptoms in Western Kenya.

A cross-sectional study was performed in children 5 through 10 years of age presenting to outpatient clinics in Nyanza Province, Kenya, in which nasal swab and blood specimens were collected during the high malaria transmission season. Patients presenting with malaria-like symptoms within 4 days of fever onset were enrolled in the study. Plasmodium parasitemia was determined by blood smear microscopy.

Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial.

Background: Rotavirus vaccine has proved effective for prevention of severe rotavirus gastroenteritis in infants in developed countries, but no efficacy studies have been done in developing countries in Asia. We assessed the clinical efficacy of live oral pentavalent rotavirus vaccine for prevention of severe rotavirus gastroenteritis in infants in Bangladesh and Vietnam.

Methods: In this multicentre, double-blind, placebo-controlled trial, undertaken in rural Matlab, Bangladesh, and urban and periurban Nha Trang, Vietnam, infants aged 4-12 weeks without symptoms of gastrointestinal disorders were randomly assigned (1:1) to receive three oral doses of pentavalent rotavirus vaccine 2 mL or placebo at around 6 weeks, 10 weeks, and 14 weeks of age, in conjunction with routine infant vaccines including oral poliovirus vaccine.

Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial.

Background: Rotavirus gastroenteritis causes many deaths in infants in sub-Saharan Africa. Because rotavirus vaccines have proven effective in developed countries but had not been tested in developing countries, we assessed efficacy of a pentavalent rotavirus vaccine against severe disease in Ghana, Kenya, and Mali between April, 2007, and March, 2009.

Methods: In our multicentre, double-blind, placebo-controlled trial, undertaken in rural areas of Ghana and Kenya and an urban area of Mali, we randomly assigned infants aged 4-12 weeks without symptoms of gastrointestinal disorders in a 1:1 ratio to receive three oral doses of pentavalent rotavirus vaccine 2 mL or placebo at around 6 weeks, 10 weeks, and 14 weeks of age.

Predictors of influenza vaccination in the Cystic Fibrosis Foundation patient registry, 2006 through 2007.

Background: Influenza vaccination is recommended for all persons with cystic fibrosis (CF). Despite this recommendation, no study has been performed to determine factors associated with receipt of influenza vaccination among persons with CF.

Methods: We conducted a 2-year cohort study from 2006 through 2007 using the CF Foundation (CFF) Patient Registry to assess predictors of influenza vaccination with logistical regression modeling.

Trivalent inactivated influenza vaccine (TIV) immunogenicity in children 6 through 23 months of age: do children of all ages respond equally?

We assessed the effect of age on immunogenicity to trivalent inactivated influenza vaccine (TIV) by comparing the immune responses to influenza vaccine antigens among three age cohorts of vaccine-naïve children aged 6-11 months, 12-17 months, and 18-23 months. In children 6-23 months of age, antibody responses to TIV appear to increase with increasing age. Despite this finding, TIV was immunogenic even in the youngest age group evaluated, further establishing its value as a tool to protect young children from influenza.

Safety of herpes zoster vaccine in the shingles prevention study: a randomized trial.

Background: The herpes zoster vaccine is effective in preventing herpes zoster and postherpetic neuralgia in immunocompetent older adults. However, its safety has not been described in depth.

Objective: To describe local adverse effects and short- and long-term safety profiles of herpes zoster vaccine in immunocompetent older adults.

Immunogenicity and safety of intradermal influenza vaccination in healthy older adults.

Background: Influenza vaccine immunogenicity is suboptimal in older persons. Intradermal (ID) vaccination may be a promising alternative to intramuscular (IM) vaccination.

Methods: This randomized trial compared the immunogenicity of 60% dose ID influenza vaccination to standard IM vaccination of full-dose or 60% dose vaccine.

Global impact of rotavirus vaccines.

The WHO has recently recommended the inclusion of rotavirus vaccine in the national immunization programs of all countries. In countries in the Americas, Europe and Australia that have adopted routine childhood immunization against rotavirus, significant reductions in the burden of severe childhood diarrhea have been observed. Besides protecting vaccinated children, disease rates also appear to be reduced in unvaccinated children, suggesting indirect benefits from vaccination (i.

Influenza vaccination rates of children in households with high-risk adults.

Objectives: Household contacts of people at high risk for influenza complications should receive yearly influenza vaccination to reduce potential viral transmission. We evaluated influenza vaccine coverage among children to determine whether or not living with a high-risk adult predicts the likelihood of being vaccinated.

Methods: Using the 2006 National Health Interview Survey, we examined influenza vaccination rates among children (aged 1-17 years) who did and did not reside in a household with an adult at high risk for influenza-related complications.

Effect of human rotavirus vaccine on severe diarrhea in African infants.

Background: Rotavirus is the most common cause of severe gastroenteritis among young children worldwide. Data are needed to assess the efficacy of the rotavirus vaccine in African children.

Methods: We conducted a randomized, placebo-controlled, multicenter trial in South Africa (3166 infants; 64.

Influenza-associated cystic fibrosis pulmonary exacerbations.

Background: Although cystic fibrosis (CF) is the most common inherited respiratory disease, the burden of influenza among individuals with CF is not well characterized.

Methods: We used the CF Foundation Patient Registry to determine the relationship between pulmonary exacerbation incidence rate and influenza virus season from July 2003 through June 2007. The outcome of interest, pulmonary exacerbation, was defined as treatment of a respiratory illness with IV antibiotics.

Evaluation of rotavirus vaccines in Asia--are there lessons to be learnt?

Rotavirus mortality is highest in the Asia-Pacific region and rotavirus vaccines could have enormous impact here. Yet, live-attenuated orally administered rotavirus vaccines have been evaluated in a small number of immunogenicity studies in some Asian countries, where the immune responses have been documented to be moderate in low-income countries with high diarrhoeal disease burden and mortality, and high in middle-/high-income countries with little reported rotavirus deaths. This review of these rotavirus clinical trials examines the results observed and attempts to draw lessons to inform decision-making, aid design of additional clinical trials and guide vaccine development by local manufacturers.