A Randomized Controlled Phase 3 Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India

Condition:   Rotavirus Infection of Children Interventions:   Biological: TV P2-VP8;   Biological: Rotarix Sponsors:   PATH;   Bill and Melinda Gates Foundation;   SK Bioscience Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials

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Purpose of review Gastroenteritis results in substantial morbidity and mortality worldwide, especially in young children in low-and-middle-income settings. Rotavirus and norovirus are the leading causes of viral gastroenteritis. Although introduction of rotavirus vaccines into childhood immunization programmes has reduced disease burden, vaccine effectiveness remains low in developing countries. Norovirus is replacing rotavirus as the most common cause of diarrhea hospitalization in settings where rotavirus vaccines are highly effective. Genetically determined host factors, such as expression of histo blood group antigen...
Source: Current Opinion in Infectious Diseases - Category: Infectious Diseases Tags: GASTROINTESTINAL INFECTIONS: Edited by Gagandeep Kang and Eric R. Houpt Source Type: research
Abstract Celiac disease is a complex autoimmune enteropathy of the small intestine that commonly occurs in genetically predisposed individuals due to intake of gluten and related proteins. Gluten consumption, duration of breast-feeding, various infections, especially frequent intestine infections, vaccinations and use of antibiotics can be linked to celiac disease. It is predicted that it affects 1% of the global population and its incidence rate is increasing. Celiac disease is closely related to Turner's syndrome, type I diabetes mellitus, Down's syndrome, and other autoimmune conditions and most people with the...
Source: Current Pharmaceutical Biotechnology - Category: Biotechnology Authors: Tags: Curr Pharm Biotechnol Source Type: research
Abstract The Developing Countries Vaccine Manufacturers Network (DCVMN) convened vaccine manufacturing experts and leaders from local and global public health organizations for its 19th Annual General Meeting. Lectures and panel discussions centered on international cooperation for better access to vaccines, and partnerships in areas ranging from vaccine research and process development, to clinical studies, regulatory, supply chain and emergency preparedness and response. Global vaccine market trends and changes that will impact vaccine financing and procurement methods were discussed as well as capital sources, ...
Source: Vaccine - Category: Allergy & Immunology Authors: Tags: Vaccine Source Type: research
CONCLUSION: Although the sensitivity and specificity of IC differ by brand type, generally, IC is not as sensitive as RT-PCR. Despite the VEs remain higher by IC, it looks comparable with that of RT-PCR in severe cases implying that VEs evaluated by IC against severe illness remain useful for VE-monitoring. PMID: 31451325 [PubMed - as supplied by publisher]
Source: Vaccine - Category: Allergy & Immunology Authors: Tags: Vaccine Source Type: research
Rotavirus vaccination has substantially reduced the incidence of rotavirus-associated gastroenteritis (RVGE) in high-income countries, but vaccine impact and estimated effectiveness are lower in low-income countries for reasons that are poorly understood. We used mathematical modeling to quantify rotavirus vaccine impact and investigate reduced vaccine effectiveness, particularly during the second year of life, in Malawi, where vaccination was introduced in October 2012 with doses at 6 and 10 weeks. We fitted models to 12 years of prevaccination data and validated the models against postvaccination data to evaluate the mag...
Source: Science Translational Medicine - Category: Biomedical Science Authors: Tags: Research Articles Source Type: research
Abstract Diarrhea remains one of the top five causes of disease and death among young children in developing nations. Fortunately, scientists are making progress developing vaccines against enterotoxigenic E. coli (ETEC) and Shigella, two of the leading diarrhea pathogens. As vaccine developers start to consider field efficacy trials of these vaccines, they should be aware of the importance of evaluating not only vaccine direct effects on the immunized, but also the herd effects that vaccination can afford to the unimmunized in a community. In a workshop held at the conference titled "Vaccines against Shigell...
Source: Vaccine - Category: Allergy & Immunology Authors: Tags: Vaccine Source Type: research
K. C. Jere et al.
Source: Emerging Infectious Diseases Journal - Category: Infectious Diseases Source Type: research
by Joseph A. Lewnard, Benjamin A. Lopman, Umesh D. Parashar, Aisleen Bennett, Naor Bar-Zeev, Nigel A. Cunliffe, Prasanna Samuel, M. Lourdes Guerrero, Guillermo Ruiz-Palacios, Gagandeep Kang, Virginia E. Pitzer Cohort studies, randomized trials, and post-licensure studies have reported reduced natural and vaccine-derived protection against rotavirus gastroenteritis (RVGE) in low- and middle-income countries. While susceptibility of children to rotavirus is known to vary within and between settings, impli cations for estimation of immune protection are not well understood. We sought to re-estimate naturally-acquired protect...
Source: PLoS Computational Biology - Category: Biology Authors: Source Type: research
(SENeo) y del Comité Asesor de Vacunas de la Asociación Española de Pediatría (CAV-AEP) Abstract Rotavirus (RV) is the leading cause of severe acute gastroenteritis in infants worldwide. Most children are infected by RV by the age of 5years, and especially in the first 2years. Two oral attenuated vaccines against RV are licensed in industrialised countries, which have proven to be safe and effective against the disease. The main objective of these vaccines has been to reproduce the natural history of infection and protect against severe disease in the first months of life. Preterm infan...
Source: Anales de Pediatria - Category: Pediatrics Authors: Tags: An Pediatr (Barc) Source Type: research
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