BLUEWILLOW BIOLOGICS INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

AbstractChlamydia trachomatis is the most commonly reported bacterial infection in the United States and in many other parts of the worldBecause untreated infection in women causes long term problems with reproduction such as infertility and ectopic pregnancychlamydia has been the focus of public health control programs over the last two decadesCurrent antibiotic treatments have not halted the increased incidence and Ctrachomatis infections now cost the US health system $billion per annumDespite mathematical modelling highlighting that even a partially effective vaccine could reverse the increasing incidence of infection and that the medical and research fields agree that a vaccine will be required to control the current epidemica human chlamydial vaccine trial has not occurred in overyearsNanoBio Corporation has developed NanoStatadjuvant technologythat allows for both intranasal and intramuscular vaccine administrationproduce balanced humoral and cell mediated immune responses and offers a protection from a challenge in number of studies that include RSVpandemic influenza and pertussisIn addition to the balanced THThimmune response NEadjuvanted vaccines elicit strong Thresponse and humoral immunity in several species including humansagainst many different antigens when delivered intranasallyUsing NanoStatwe have shown that intranasalINimmunization of mice with the chlamydial major outer membrane proteinMOMPreduces the duration of infection and greatly reduces inflammatory oviduct damage following genital chlamydia infectionAdditionallyintramuscular immunization with MOMP NEdemonstrated the efficacy of this vaccine in decreasing both infection and pathology in mouse modelDrMahony has recently developed a novel and improved type III secretionT SSbased chlamydial vaccine antigenBDthat has yielded very promising results by reducing bacterial shedding byand upper genital tract pathology bywhich should be able to offer protection from multiple chlamydia serovars based on the highly conserved nature of the T SS proteinsFurthermorethe Ctrachomatis mouse model developed in DrMahony s laboratory recapitulates infections seen in humans with Ctrachomatis and thus are more relevant for evaluating the efficacy of chlamydia vaccinesas compared to Cmuridarum mouse models that are routinely used for chlamydia studiesThe preliminary data support further evaluation of an NE adjuvanted chlamydia vaccine to demonstrate protection against both infection and pathologyIn this proposalwe will utilize this newly developed Ctrachomatis mouse model and both intranasal and intramuscular applications of nanoemulsion adjuvanted BDvaccine to further develop and demonstrate the importance of NanoStatTM in preventing chlamydial disease and establish proof of concept necessary to initiate human clinical trials of a chlamydia vaccineThis project will identify an effective vaccine composition regiment and provide proof of concept data to seek SBIR Phase II funding to support further development of safe and efficacious chlamydia vaccine Project Narrative Chlamydia trachomatis is the most commonly reported bacterial infection in the United States and in many other parts of the worldUntreated infections in women are one of the major causes of infertility and ectopic pregnanciesDespite wide scale roll out of chlamydia control programs in the United StatesCanadaand Scandinaviareported cases of chlamydia did not declineCurrentlythere is no approved vaccine for chlamydiaThereforethe proposed studies will develop a novel nanoemulsion based vaccine using a using multi component antigenBDconsisting of the N terminalamino acids of Ctrachomatis CopBCopDand full length CTto prevent both infection and pelvic inflammatory diseasePIDDevelopment of a safe and highly effective nanoemulsion based vaccine against Chlamydia trachomatis would have great medical value for prevention of infection and its complications in the United States and worldwide