Aligning new interventions with developing country health systems: target product profiles, presentation, and clinical trial design.

Many new interventions are being created to address health problems of the developing world. However, many developing countries have fragile health systems and find it difficult to accommodate change. Consequently, it is essential that new interventions are well aligned with health systems and their users. Establishing target product profiles (TPPs) is a critical, early step towards tailoring interventions to suit both of these constituencies. Specific analyses can help identify and establish relevant TPP criteria such as optimal formulation, presentation and packaging. Clinical trials for a new intervention should be designed to address both TPP-specific questions and anticipated use of the intervention in target countries. Examples are provided from research on malaria vaccines that are also applicable to other new public health interventions.

Rotavirus burden among children in the newly independent states of the former union of soviet socialist republics: literature review and first-year results from the rotavirus surveillance network.

BACKGROUND: Data on rotavirus burden among children in the 15 newly independent states of the former Union of Soviet Socialist Republics, particularly contemporary data from poorer countries, are not widely available. These data are desired by policy makers to assess the value of rotavirus vaccination, especially since the GAVI Alliance approved financial support for the region's eligible countries. The Rotavirus Surveillance Network was established to provide these data. METHODS: We reviewed the region's literature on rotavirus burden. We established an active surveillance network for rotavirus and analyzed data from 2007 from 4 sentinel hospitals in 3 countries (Georgia, Tajikistan, and Ukraine) that were collected using standardized enrollment and stool sample testing methods. RESULTS: Specimens for rotavirus testing were collected before 1997 in most studies, and the majority of studies were from 1 country, the Russian Federation. Overall, the studies indicated that approximately 33% of hospitalizations for gastroenteritis among children were attributable to rotavirus. The Rotavirus Surveillance Network documented that 1425 (42%) of 3374 hospitalizations for acute gastroenteritis among children aged <5 years were attributable to rotavirus (site median, 40%). Seasonal peaks (autumn through spring) were observed. Genotype data on 323 samples showed that G1P[8] was the most common type (32%), followed by G9P[8] (20%), G2P[4] (18%), and G4P[8] (18%). Infections due to G10 and G12 and mixed infections were also detected. CONCLUSIONS: The burden of rotavirus disease in the newly independent states is substantial. Vaccines should be considered for disease prevention.

Health systems and immunization financing for human papillomavirus vaccine introduction in low-resource settings.

This descriptive qualitative study synthesizes health system and immunization financing assessments performed through formative research in India, Peru, Uganda, and Vietnam using a non-probability sample of national and sub-national stakeholders; and recommends appropriate and effective strategies for HPV vaccine delivery in low-resource settings. We conclude that maximum feasibility and acceptability and lowest cost for delivering HPV vaccine can be achieved by implementing through national immunization programs; by partnering with other sectors, such as education and maternal-child health; by strengthening existing human resources and cold chain infrastructures where needed; and finally, by considering schools for reaching the target population.

Country recommendations on the inclusion of HPV vaccines in national immunization programmes among high-income countries, June 2006-January 2008.

We analysed country recommendations and funding plans finalized through January 2008 for the inclusion of quadrivalent and bivalent human papillomavirus (HPV) vaccines in national immunization programmes. Fifteen industrialized countries have recommended HPV vaccine use based on careful review of scientific evidence and cost-effectiveness. There was a strong consensus among the guidelines regarding assessment of vaccine safety and efficacy, selection of primary target populations for vaccination, vaccine delivery strategies, and the need for vaccinated females to seek cervical cancer screening. The analysis informs ongoing discussions in several countries considering HPV vaccines for national immunization programmes and discussions at the World Health Organization about global recommendations for HPV vaccine use for national immunization programmes.

Impact of alternative approaches to accelerated measles control: experience in the African region, 1996-2002.

From 1996 to 2000, several African countries accelerated measles control by providing a second opportunity for measles vaccine through supplemental campaigns. Fifteen countries completed campaigns in children aged 9 months to 14 years. Seven countries completed campaigns in children aged 9-59 months. In almost all countries that conducted campaigns in children aged 9 months to 14 years, measles deaths were reduced to near zero. In six countries, near-zero measles mortality has been maintained for 4-6 years. Supplemental immunization in children <5 years old was only partially effective (range, 0-67%) in reducing mortality. Measles cases decreased by 50% when routine vaccination coverage increased from 50% to 80%. Initial measles campaigns in children aged 9 months to 14 years, follow-up campaigns in those aged 9-59 months every 3-5 years, and increased routine coverage to 80% will be needed to reduce and maintain measles deaths in African countries at near zero.