This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator. Influenza is a serious illness which occurs in epidemic fashion every year. The recent emergence of novel influenza virus strains (the A/H5N1 strain; also called the 'bird flu' or 'avian flu') in human populations has bolstered global efforts to develop pandemic preparedness plans. According to the World Health Organization, nearly 300 human cases of H5 bird flu have been identified over half of whom have died. Global spread of this disease would be catastrophic. Development and testing of an influenza vaccine against potential H5N1 pandemic strains is an international public health priority. Our research center has taken part in 4 NIH/DMID-sponsored clinical research studies to evaluate the sanofi pasteur inactivated, A/H5N1 influenza vaccine: 1) a primary study in healthy adults (10410-01[104]), 2) a booster study in healthy adults (10410-01[108]), 3) a study in healthy elderly adults (10410-01[106]), and 4) a study in healthy children 2-9 years of age (10410-01[105]). Clinical visits have been completed for all of these studies and data for some of the studies are now available. Published data from the adult study suggests that the vaccine is generally safe and immunogenic (produces an acceptable immune response or antibody level). Preliminary analyses of the safety and immune response data in children have shown that it is similar to that seen in adults. The multicenter pediatric study included a provision (as outlined in the protocol and consent form) that stated if the vaccine was found to be safe and immunogenic, children who received the placebo would be offered the chance to receive the A/H5N1 vaccine in a subsequent study. The purpose of this study is to now offer the A/H5N1 avian influenza vaccine to the placebo recipients from the previous pediatric trial. This study will enroll subjects who took part in DMID protocol 04-077 (LABioMed Project# 10410-01[105]). Nationally, the study will include up to 55 children from the prior study: 23 participants who received placebo and 32 participants who were incorrectly underdosed (given 1/10th of the vaccine dose specified in the protocol). At our site, we expect up to 22 children who were underdosed or received placebo to take part in this open label study.
Showing the most recent 10 out of 1232 publications
