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Vaccines continue to play a central role in our ability to prevent disease, save lives, and improve health. The scientific community, including our own researchers, are driven by a shared purpose to improve vaccine technologies and bring the benefits of immunization to everyone, regardless of where they live – as soon as possible, especially when the medical need is considerable. Vaccine developers and manufacturers (sometimes referred to as "study sponsors" or "applicants") are exploring technological advancements to translate breakthrough discoveries into novel vaccines which have the potential to provide protection from life-threatening and debilitating infectious diseases. Developing new vaccines is a lengthy process regulated by guidance provided by independent organizations, National Regulatory Authorities (NRAs) and the World Health Organization. As most infectious diseases can span a considerable area of the world, clinical trials are often conducted across different countries and regions. Regulatory requirements for clinical trials (both Chemistry Manufacturing & Controls – CMC, nonclinical and clinical) vary significantly between the different countries and regions adding to the complexity of vaccine development and leading to significant delays in the development of novel vaccines and ultimately equitable access for populations to these innovations. Without progress in terms of regulatory convergence and harmonization the benefits from these scientific advancements will not be fully realized. There is an urgent need by global bodies such as WHO to partner with and the NRAs to establish and implement. 1. a common, global set of requirements for Clinical Trial Application (CTAs) per Phase of Development. 2. a parallel ethical committee and regulatory authority review rather than sequential reviews. 3. clear and transparent assessment timelines and commitment to these timelines. 4. a focus on reduced regulatory burden overall for NRAs, Ethics Committees (ECs) and vaccine developers. [ABSTRACT FROM AUTHOR]

Background: Recent epidemiologic data on travelers' diarrhea (TD) are essential for the evaluation of conventional and future prophylactic and therapeutic measures.Methods: To determine the epidemiology, including risk factors, impact and quality-of-life evaluation of TD, a cross-sectional survey was conducted over 12 months at the airports of Mombasa (Kenya), Goa (India), Montego Bay (Jamaica) and Fortaleza (Brazil) by distributing questionnaires to visitors just prior to their flying home. The study period was March 1996 to July 1998.Results: Overall, 73,630 short-term visitors completed a questionnaire. The total diarrhea attack rate varied between a high of 54.6% in Mombasa and a low of 13.6% in Fortaleza, but only between 31.5% and 5.4% of all travelers had classic TD. The 14-day incidence rates varied between 19.5% and 65.7%. Few travelers meticulously avoided potentially dangerous food items, although in India and Kenya most travelers avoided those considered most dangerous. Risk factors were stays exceeding 1 week, age between 15 and 30 years, and residence in the UK. The impact, measured as incapacity or quality-of-life scores, was very considerable.Conclusions: TD continues to affect vacationers and business travelers as frequently as it did some 20 years ago. Compliance with recommendations to reduce exposure to pathogens by avoiding dangerous food items is poor among travelers from all countries. Implementation of food safety education programs may be difficult to achieve. [ABSTRACT FROM AUTHOR]

Background: The etiological agents of hepatitis A, hepatitis B, and typhoid fever share similar patterns of global distribution, and cause significant disease burden in travelers to endemic countries. Combined vaccination against all three diseases, based on currently available vaccines, would promote compliance and convenience for travelers. This clinical study evaluated the feasibility of extemporaneously syringe-mixed hepatitis A and B vaccine (Twinrix) and a Vi polysaccharide vaccine (Typherix) in healthy adults, and compared this to concomitant administration of the vaccines in separate arms.Methods: The mixed dose of vaccine contained at least 720 enzyme-linked immunosorbent assay (ELISA) units of the inactivated hepatitis A antigen, 20 microg of the recombinant hepatitis B antigen and 25 microg of the Vi polysaccharide typhoid antigen in 1.5 mL. The study was conducted in 200 healthy 18- to 45-year-old volunteers.Results: Equivalence between the vaccines mixed before administration and the concomitantly administered vaccines was shown in terms of seroconversion and seroprotection. With the exception of local injection site soreness, which was higher in the mixed administration group, the reactogencity was similar for both groups. In both vaccination groups more than 95% of the subjects were anti-hepatitis A virus and anti-Vi seropositive 1 month after the first vaccination. With regard to hepatitis B, a strong response was achieved in both groups, with more than two-thirds of the subjects protected 2 months after the start of the immunization course.Conclusion: These results support the feasibility of extemporaneously syringe-mixed combined hepatitis A and B vaccine with a Vi polysaccharide typhoid vaccine, administered in healthy adults. [ABSTRACT FROM AUTHOR]