WNPRC CENTRALIZED PROTOCOL IMPLEMENTATION (CPI) UNIT

University Of Wisconsin-Madison, Madison WI

Investigators

Linked publications & trials

Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Objective: To provide core, campus and non-host investigators with organized and efficient WNPRC and UW-Madison resources, protocol management and expertise. Progress and Concerns: Since March 2009, CPI has supported 43 different projects this year involving 24 investigators (14 WNPRC core scientists, 6 UW affiliates, 2 affiliates from other academic institutions, and 2 investigators from the private sector). There were changes in the types of projects as some ended and others began. In addition, different investigators left the UW and were replaced by other UW affiliates. There were 20 new projects this year: 11 WNPRC core scientists, 6 UW affiliates, 2 other academic affiliates, and the two private were also new: One of the two clients was testing new pharmaceuticals for dyslipidemia and used animals from the Aging Resource. The other, through two studies, was seeking to determine the neurovirulent effects resulting from the intra-thalamic administration of a live-attenuated Measles vaccine virus and a live-attenuated Rubella vaccine virus, both in development. In the first study, juvenile cynomolgus monkeys (Macaca fascicularis) were used to compare and contrast the pathology produced by these test vaccine viruses to commercial measles and rubella vaccines, and saline injected controls. Veterinary Services, Colony Management, Compliance &Training, and Central Protocol Implementation personnel collaborated to perform these GLP studies. In the second study, animals receiving the test vaccine virus and the reference vaccine were followed until Day 21 post-inoculation and the control animals were followed until Day 31 post-inoculation. Clinical observations and food intake values were documented on a daily basis. CBC, serum chemistry, and CSF data as well as serum and CSF antibody data was collected at scheduled intervals throughout the study. Full gross and histopathological data was collected on all animals enrolled in the study. The goal of these studies was to collect clinical data on these test vaccine viruses prior to the performance of toxicity studies at a contract research organization. The ultimate goal was to combine these vaccine viruses in a new, and safer trivalent vaccine for Measles, Rubella, and a third undetermined infectious organism. Since the total number of CPI projects remained similar, this may be an indication of the capabilities of support that the CPI unit and the primate resource are able to maintain at any one time. There were many new projects this year due to federal supplement funding as well as new and renewal projects replacing finished projects. In response to increasingly complex requests for NHP samples from investigators, CPI worked with Pathology to expand and rename the tissue distribution program to Nonhuman Primate Biological Materials Distribution (NHPBMD). Tissues collected under this program provide samples to researchers from animals that are available, but not requested on any specific UW research protocols. This program combines procedures for collection of both ante-mortem and/or postmortem samples for research purposes. By coordinating our efforts, we have increased customer service while reducing any redundant efforts. Future plans include providing a web-based application process for the NHPBMD program. CPI has provided access to ante-mortem tissue to 9 investigators through this program (2 UW, 3 non-UW, and 4 private sector). All of these included tissue as blood, serum, or semen and did not include any provision of organs. Allocation of Resource Access: Projects must fall within the mission of WNPRC, be approved by the director and executive committee, and WNPRC have the resources to provide support. In addition, CPI emphasized the defined three core areas (Aging and Metabolism, Immunology and Virology, Reproduction and Regenerative Medicine) that match the major research areas and resources at WNPRC and identify individual core scientists as potential co-investigators for consultation in the respective cores. Dissemination: In addition to the WNPRC web site, we have developed a brochure to disseminate at meetings and presentations. As well as relying on recommendations by core and affiliate scientists, we send CPI staff to annual scientific meetings to present what resources and techniques are available to the scientific members in attendance. Dr. Schultz-Darken has been involved with the ICTR program at the UW and has presented information to potential translational researchers. One UW researcher has submitted a grant for a project utilizing CPI services for the WNPRC resource as a result of this. Training: The veterinary head of CPI is responsible for all training of CPI personnel for the multitude of procedures cited above and utilizes other members of Veterinary Services and the university as needed. Written instruction as well as hands-on training and oversight of procedures to assure proficiency are utilized to provide a highly skilled technical staff to researchers. A manual with over 50 detailed SOPs is maintained by the unit to provide detailed guides for simple and complex procedures in the areas of reproduction, sample procurement, treatment, behavior, observation, training, imaging, processing and shipping. We continue to improve on our comprehensive system of technician training documentation to assure that our staff is appropriately cross-trained in as many research areas as possible. Publications: Virtually all publications relying on WNPRC resources in part or in full involved the use of the CPI Unit. However, most notably the following publication included CPI members as co-authors: Li Q, Estes JD, Schlievert PM, Duan L, Brosnahan AJ, Southern PJ, Reilly CS, Peterson ML, Schultz-Darken N, Brunner KG, Nephew KR, Pambuccian S, Lifson JD, Carlis JV, Haase AT. Glycerol monolaurate prevents mucosal SIV transmission. Nature. 2009;458(7241):1034-8.