Clinical Research	Contact
Optimizing Vaccine Responsiveness in HIV-1 and HCV Infections by Identifying Determinants of Responsiveness: A Pilot Study.  PI: Cara Wilson, MD	Graham Ray, RN, MSN graham.ray@UCDenver.edu
Comparison of an investigational conjugated pneumococcal vaccine with the existing licensed pneumococcal vaccine in adults 70 and older. The trial looks at how well individuals tolerate a dose of the investigational pneumo vaccine a year after the individual has received a dose of the existing or the investigational vaccine.  PI: Edward Janoff, MD	Nancy Lang, RN nancy.lang@ucdenver.edu
Evaluation of change in effectiveness or safety of either the flu (TIV) vaccine or the investigational pneumococcal vaccine if these are given together. The study also examines the immune response when a second investigational pneumococcal vaccine is given five years after the first vaccine, in this 50‑59 year old group.    PI: Edward Janoff, MD	Nancy Lang, RN nancy.lang@ucdenver.edu
Novel Influenza Vaccine.  We are conducting a Phase II trial of a new vaccine that links a conserved influenza vaccine protein, M2e, to an innate immune adjuvant, flagellin, a TLR5 agonist.  The study collaboratively characterizes basic T and B cell responses to the vaccine over time in healthy adults by a variety of modalities.  PI: Edward N. Janoff, M.D.	Nancy Lang, RN nancy.lang@ucdenver.edu
A Phase II, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX® (varicella) in human immunodeficiency virus (HIV)-1-infected adults on potent combination ART with conserved immune function.    PI: Thomas Campbell, MD	Graham Ray, RN, MSN graham.ray@UCDenver.edu
A Phase III clinical trial to evaluate the efficacy, immunogenicity, safety and tolerability of ZOSTAVAX® (varicella) in subjects 50 to 59 Years of age.  PI: Myron Levin, MD	Nancy Lang, RN nancy.lang@ucdenver.edu
Long-term persistance of Zoster vaccine (ZOSTAVAX®) efficacy in subjects 60 years of age and older.  PI: Myron Levin, MD	Carol Workman, RN carol.workman@ucdenver.edu
A double-blind, randomized, controlled Phase III study to assess the prophylactic efficacy and safety of gD-Alum/MPL vaccine in the prevention of genital herpes disease in young women who are HSV-1 and HSV-2 seronegative.  PI: Myron Levin, MD	Carol Workman, RN carol.workman@ucdenver.edu Nancy Lang, RN nancy.lang@ucdenver.edu
A phase I/II, double-blind, randomized, controlled, dose-range study to assess the safety and immunogenicity of an HPV-16/18/31/45 VLP/ASO4 vaccine administered intramuscularly according to a 3-dose schedule (0, 1, 6 month) in healthy adult females 18-25 years of age.  PI: Myron Levin, MD	Carol Workman, RN carol.workman@ucdenver.edu
A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of an HPV-16/18 VLP/ASO4 vaccine administered intramuscularly according to a 3-dose schedule (0, 1, 6 month) in healthy adult females aged 26 to 55 years.  PI: Myron Levin, MD	Carol Workman, RN carol.workman@ucdenver.edu
A phase IV, multi-year efficacy study of Fluzone high-dose trivalent influenza vaccine compared with Fluzone® vaccine in adults > 65 years of age.  PI: Mryon Levin, MD	Nancy Lang, RN nancy.lang@ucdenver.edu
Cationic liposome-DNA complexes (CLDC) as adjuvants for mucosal vaccines. CLDC's have been shown to be effective adjuvants for parenteral vaccines. This project is using mouse models to investigate the effectiveness of CLDC as mucosal vaccine adjuvants, their mechanism of action, and their potency relative to other mucosal vaccine adjuvants.  PI: Steven Dow, DVM, PhD	Steven Dow, DVM, PhD steven.dow@colostate.edu
Inhaled subunit vaccines for Burkholderia pseudomallei. In collaboration with Dr. Mark Estes at the UTMB, this project is evaluating the protective efficacy of 3 different B. mallei subunit vaccines for cross protection against B. pseudomallei infection.  Protective efficacy is being assessed in mice immunized by the i.n. route with recombinant antigens and CLDC adjuvant and then subjected to lethal inhalational challenge with B. pseudomallei.  PI: Steven Dow, DVM, PhD	Steven Dow, DVM, PhD steven.dow@colostate.edu
Mucosally-delivered cationic-DNA liposome complexes for induction of innate immune protection against pneumonic bacterial pathogens. Mucosal delivery of CLDC elicits strong local activation of innate immunity. We are evaluating the immunological mechanisms by which inhaled CLDC to elicit protection against acute challenge with bacterial pathogens including Francisella and Burkholderia.  PI: Steven Dow, DVM, PhD	Steven Dow, DVM, PhD steven.dow@colostate.edu
Orally delivered non-replicating subunit vaccine against Yersinia pestis. These studies are investigating the ability of CLDC to function as an adjuvant for oral delivery of protein antigen vaccine against Yersinia pestis.  Protective immunity following oral immunization is being assessed by lethal inhalational challenge with virulent Y. pestis.  PI: Steven Dow, DVM, PhD	Steven Dow, DVM, PhD steven.dow@colostate.edu