The Clinical Core, located at the University of Washington Virology Research Clinic (UW-VRC), has been devoted to genital herpes simplex virus (HSV) research since it was founded neariy 40 years ago.
Specific Aims of the Clinical Core are 1) To recruit, enroll, and retain participants into research protocols from defined populations, including participants with mild and severe genital HSV-2 phenotypes for Projects 2 &3, and participants with primary genital HSV-1 infection for Project 4;2) To ensure integrity of data collected for Projects 2, 3, and 4 by adhering to study procedures and promoting the highest standards of human subjects research, including adherence to Good Clinical Pracfice;and 3) To obtain clinical specimens required for virologic and immunologic invesfigafions including swabs from mucosal sites for Projects 3 &4, genital biopsies for Projects 2 &3, and blood and detailed clinical histories for Projects 2, 3, &4. In addition, the Clinical Core will be responsible for training staff in Thika, Kenya, for Project 1. The Clinical Core has pioneered intensive genital specimen collecfion to define the natural history of HSV shedding and host-pathogen interactions. Our track record shows that we can retain participants in these intensive protocols which involve daily self-collected genital swabs. We have enrolled neariy 1000 participants in such studies. We have developed expertise in collection of genital biopsies, and we can safely collect serial genital biopsies from participants for detailed immunological and pathogenesis studies proposed in Scientific Projects. The Clinical Core collaborates closely with the Laboratory Core and the Statistical Core to evaluate new HSV testing methods, such as HSV PCR, and to answer novel questions in HSV research and we will continue to do so in this POI. The Clinical Core will also ensure that all clinical research is conducted with the highest ethical standards and with adherence to Good Clinical Practice (GCP).
The Clinical Core is located atthe University of Washington Virology Research Clinic (UW-VRC) and will be responsible for recruitment, enrollment and retenfion of participants into protocols described in Projects 2, 3, and 4, and training of staff in Kenya for Project 1. We will obtain detailed histories, blood samples, genital swabs, and genital biopsies, and we will ensure that Good Clinical Practice is followed in our studies.
|Magaret, Amalia S; Mujugira, Andrew; Hughes, James P et al. (2016) Effect of Condom Use on Per-act HSV-2 Transmission Risk in HIV-1, HSV-2-discordant Couples. Clin Infect Dis 62:456-61|
|Oseso, Linda; Magaret, Amalia S; Jerome, Keith R et al. (2016) Attitudes and Willingness to Assume Risk of Experimental Therapy to Eradicate Genital Herpes Simplex Virus Infection. Sex Transm Dis 43:566-71|
|Magaret, A; Dong, L; John, M et al. (2016) HLA Class I and II alleles, heterozygosity and HLA-KIR interactions are associated with rates of genital HSV shedding and lesions. Genes Immun 17:412-418|
|Jing, Lichen; Laing, Kerry J; Dong, Lichun et al. (2016) Extensive CD4 and CD8 T Cell Cross-Reactivity between Alphaherpesviruses. J Immunol 196:2205-18|
|Manguro, Griffins O; Masese, Linnet N; Deya, Ruth W et al. (2016) Genital HSV Shedding among Kenyan Women Initiating Antiretroviral Therapy. PLoS One 11:e0163541|
|Ramchandani, Meena; Kong, Marlene; Tronstein, Elizabeth et al. (2016) Herpes Simplex Virus Type 1 Shedding in Tears and Nasal and Oral Mucosa of Healthy Adults. Sex Transm Dis 43:756-760|
|Milman, Neta; Zhu, Jia; Johnston, Christine et al. (2016) In Situ Detection of Regulatory T Cells in Human Genital Herpes Simplex Virus Type 2 (HSV-2) Reactivation and Their Influence on Spontaneous HSV-2 Reactivation. J Infect Dis 214:23-31|
|Tjernlund, Annelie; Burgener, Adam; Lindvall, Jessica M et al. (2016) In Situ Staining and Laser Capture Microdissection of Lymph Node Residing SIV Gag-Specific CD8+ T cells--A Tool to Interrogate a Functional Immune Response Ex Vivo. PLoS One 11:e0149907|
|Nason, Martha C; Patel, Eshan U; Kirkpatrick, Allison R et al. (2016) Immunological Signaling During Herpes Simplex Virus-2 and Cytomegalovirus Vaginal Shedding After Initiation of Antiretroviral Treatment. Open Forum Infect Dis 3:ofw073|
|Bender Ignacio, Rachel A; Goldman, Jason D; Magaret, Amalia S et al. (2016) Patterns of human herpesvirus-8 oral shedding among diverse cohorts of human herpesvirus-8 seropositive persons. Infect Agent Cancer 11:7|
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