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Mucosal and Vaccine Research Colorado
 

Ongoing Research

Clinical, Pre-Clinical and Animal Studies


 

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

 

 Pre-Clinical / Animal Research  Contact

Development of flavivirus DNA vaccines. West Nile virus (WNV) and dengue viruses serotype 1 to 4 (DENV-1 to DENV-4) are important mosquito-borne viral pathogens for which there is a critical need for cost-effective human vaccines. Current tetravalent live-attenuated dengue virus vaccine candidates under clinical trials failed to stimulate balanced protective immune responses to each of the serotypes. Safety is a critical consideration for WNV vaccine because those most seriously affected by the disease are the immunologically suppressed or elderly. Our long term goal is to develop safe and cost-effective vaccines to prevent the health threat from dengue, West Nile and other emerging flaviviruses.  PI: Dr. Gwong-Jen J. Chang

Dr. Gwong-Jen J. Chang

gxc7@CDC.GOV

 

 

Development of Genetically Engineered Live Attenuated Tetravalent Dengue Vaccine. We have developed a candidate live attenuated tetravalent Dengue (DEN) vaccine consisting of a mixture of dengue serotype 2 virus (DENV-2) and three chimeric DENV strains (DENVax-1, DENVax-2, DENVax-3, and DENVax-4) that express the antigenic membrane and envelope proteins from each of the four DENV serotypes in the genetic background of the candidate DENV-2 PDK 53 vaccine virus. More... PI:  Claire Y.H. Huang 

Claire Y.H. Huang

yxh0@CDC.GOV

 

Development of Genetically Engineered Live Attenuated West Nile vaccine. We have also developed a candidate live attenuated West Nile virus (WNV) vaccine based on the same attenuated DENV-2 PDK-53 vaccine virus vector. This chimeric DENV-2/WNV virus expresses the membrane and envelope proteins of West Nile virus (WNV) in the DENV-2 background. The chimeric vaccine virus was further engineered to improve its genetic stability and fitness for growth in certified cells for vaccine production. More... PI: Claire Y.H. Huang

Claire Y.H. Huang

yxh0@CDC.GOV

 

Novel approaches for the development of live and inactivated viral vaccines. Currently, no vaccines exist for a significant number of historically important viral pathogens and newly emerging viral zoonotic diseases. In part, this situation results from the incompatibility of existing methodologies with the challenges posed by a wide array of emerging viruses. The extent of attenuation mediated by approaches such as serial passaging of viruses, viral recombination and directed molecular evolution is unpredictable and this characteristic contributes to the lengthy production times for many vaccines made using these strategies. Likewise, the safety of a number of live viral vaccines is compromised by their dependance on relatively few attenuation determinants. We aim to further define a novel strategy to intuitively construct live-attenuated viruses (LAV) that is applicable to the development of vaccines to a broad array of acute viral diseases.  PI: Aaron C. Brault, PhD

Aaron C. Brault, PhD

ABrault@CDC.GOV

 

 

  Mucosal and Vaccine Research Colorado

  12631 East 17th Avenue, Suite 7408 • Mail Stop 8205 • Aurora, CO 80045

Program Administrator:  Carola Hagenau  Phone: 303-724-8499 • Fax: 303-724-0802 • E-mail: MAVRC@ucdenver.edu                           

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