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Biomedical subjects

Luis Jodar

Publications and source records attributed to Luis Jodar.

8 recordsLinked to original sources
PubMed2006

Implementation of good clinical practice guidelines in vaccine trials in developing countries.

The practicalities when applying the ICH GCPs (International Conference on Harmonization 1996 Good Clinical Practices [EU, MHLW, FDA. International Conference on Harmonization Guideline for Good Clinical Practice; 1997] in less developed countries (ldcs) are seldom discussed and we found no guidelines as how to "adapt" them. Below we illustrate how ICH GCP principles can be implemented in different settings. We have recently conducted in Asia (Hechi, China; Karachi, Pakistan; Hue, Vietnam; North Jakarta, Indonesia and Kolkata, India) large-scale cluster-randomized effectiveness evaluations of the Vi polysaccharide typhoid fever vaccine (Vi PS project) among approximately 200,000 individuals(1)[Acosta CJ, Galindo CM, Ali M, Abu-Elyazeed R, Ochiai RL Danovaro-Holliday MC et al. A multi-country cluster randomized controlled effectiveness evaluation to accelerate the introduction of Vi polysaccharide typhoid vaccine in developing countries in Asia: rationale and design. TMIH 2005;10(12):1219-1228]. There is no doubt on the importance of ICH GCP in its contribution to ethical and scientifically sound clinical research. However, when the ICH GCP is implemented in ldcs some considerations must be made in order to adequately tailor them. Vaccine trials in ldcs are a frequent setting for such challenges because of the increased global interest conducting health research in such countries. The ICH GCP principles are discussed below within the framework of this recent typhoid fever vaccine study experience.

Developing Countries↗
PubMed2006

Haemophilus influenzae type B meningitis among children in Hanoi, Vietnam: epidemiologic patterns and estimates of H. Influenzae type B disease burden.

From March 2000 to February 2002, a population-based study of Haemophilus influenzae type b (Hib) meningitis was conducted among children less than five years of age in Hanoi, Vietnam. Children with suspected bacterial meningitis were referred to hospitals and each patient underwent standardized clinical examination and microbiologic testing. In Hanoi, 580 children were evaluated for bacterial meningitis and 23 (4%) had confirmed or probable Hib meningitis. The incidence of all Hib meningitis was 12/100,000 child-years less than five years of age and 26/100,000 child-years less than two years of age. Nationally, an estimated 1,005 children less than five years of age are hospitalized for Hib meningitis and 5,107 are hospitalized for Hib pneumonia. Among children with Hib meningitis, at least 100 will develop severe neurologic sequelae and 40 will die. These data suggest there is a substantial burden of Hib disease in Vietnam. National leaders will be provided with these data to facilitate development of national vaccination policies for children in Vietnam.

Child, Preschool↗
PubMed2005

Introducing new vaccines into developing countries: obstacles, opportunities and complexities.

Infectious diseases are thought to account for nearly 25% of all deaths worldwide, and extract a disproportionate toll in developing countries. Moreover, infectious diseases are now appreciated to be major causes of the poverty and economic underdevelopment that characterize the world's poorest countries. Development and deployment of new vaccines to prevent infectious diseases in developing countries have therefore become high priorities in the global health agenda.

Developing Countries↗
PubMed2005

Salmonella paratyphi A rates, Asia.

Little is known about the causes of enteric fever in Asia. Most cases are believed to be caused by Salmonella enterica serovar Typhi and the remainder by S. Paratyphi A. We compared their incidences by using standardized methods from population-based studies in China, Indonesia, India, and Pakistan.

Adolescent↗
PubMed2004

Technologies that make administration of vaccines safer.

There is an ever-expanding technology that is aimed at making the administration of vaccines safer. Conventional ways of administering vaccines are being upgraded, modified or replaced by a wide variety of innovations. The paradigm of liquid vaccines, needles and syringes is slow to change, but already developments are occurring that will change for ever the way vaccines are administered and will improve the safety record of immunization. The oral route of vaccine administration has generally been thought of as safe, but until now only the polio vaccine has been widely used in this way. The conventional method of vaccine administration is by injection. Many ingenious devices have become available that now make injecting safer. Inventors are now looking imaginatively to alternative routes and technologies for delivering vaccines. Vaccines are generally manufactured to extremely high standards and rarely are shown to be the cause of safety issues. People remain the weakest safety link is vaccine administration. Technologies that bypasses the ability of man to make bad decisions or to behave incorrectly are of tremendous value. The vaccine world is in the middle of a radical re-think about how vaccines might best be administered. The presentation of the vaccine can be altered to fit new technologies such as powder jet guns, or skin patches. Even the conventional needle and syringe have evolved to much safer versions, and are set to continue this evolution. All this means even safer vaccines and their delivery.

Drug Compounding↗
PubMed2004

Translational research to assist policy decisions about introducing new vaccines in developing countries.

Few new-generation vaccines have found their way into public-health programmes for the poor in developing countries, and for those that have, delays of years or even decades after their licensure and introduction in industrialized countries have been the rule. Financial constraints and political obstacles have played major roles in delaying the introduction of the vaccines. Also contributing to this situation has been a dearth of needed research. While past analyses have identified inadequate support for conducting Phase 1 studies as an obstacle, other types of translational research are also needed. Vaccines may perform less well in impoverished populations in the developing world than in more affluent populations. Consequently, Phase 2 and Phase 3 trials of new vaccines in developing countries are a second essential type of translational research needed for the introduction of vaccines in developing countries. Moreover, even for vaccines that have performed well in pre-licensure human trials in developing countries, doubts often remain about whether the local disease burden justifies introduction of vaccine, whether the vaccine will be cost-effective, and whether introduction of vaccine will be programmatically feasible, acceptable, and financially sustainable. Because these residual doubts constitute obstacles to the introduction of vaccine, a third type of translational research is needed to provide this evidence required for policy. In this paper, these three types of translational research are illustrated with projects being undertaken in the Diseases of the Most Impoverished Programme. The Programme is conducting translational research to accelerate the rational introduction of new vaccines against cholera, shigellosis, and typhoid fever in developing countries affected by these diseases.

Clinical Trials as Topic↗