Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
Completed
Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or Days 0, 56 and 121).
Gender:
ALL
Ages:
Between 18 years and 55 years
Trial Updated:
07/28/2020
Locations: Central Kentucky Research Associates, Lexington, Kentucky
Conditions: Plague Vaccine
Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59
Completed
The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains. The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvan... Read More
Gender:
ALL
Ages:
Between 18 years and 49 years
Trial Updated:
06/30/2020
Locations: Central Kentucky Research Associates Inc, Lexington, Kentucky
Conditions: Influenza A Virus, H5N1 Subtype
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children
Completed
This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.
Gender:
ALL
Ages:
Between 6 months and 17 years
Trial Updated:
08/22/2018
Locations: GSK Investigational Site, Lexington, Kentucky
Conditions: Influenza
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
Completed
The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
Gender:
ALL
Ages:
Between 6 weeks and 12 weeks
Trial Updated:
08/22/2018
Locations: GSK Investigational Site, Bardstown, Kentucky +1 locations
Conditions: Infections, Meningococcal
Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)
Completed
This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
08/22/2018
Locations: GSK Investigational Site, Lexington, Kentucky
Conditions: Influenza
HerpeVac Trial for Young Women
Completed
The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected. The study will enroll approximately 7550 healthy women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine (experimental group) or hepatitis A vaccine (control group). Participants will receive their assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and additional unscheduled visits for an evalua... Read More
Gender:
FEMALE
Ages:
Between 18 years and 30 years
Trial Updated:
07/26/2018
Locations: GSK Investigational Site, Bardstown, Kentucky +2 locations
Conditions: Herpes Simplex Infection
Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
Completed
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.
Gender:
FEMALE
Ages:
Between 18 years and 45 years
Trial Updated:
05/31/2018
Locations: GSK Investigational Site, Lexington, Kentucky
Conditions: Respiratory Syncytial Virus Infections
Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy Adults
Completed
This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, has an impact on delivery location. The secondary objective is to evaluate delivery with fasting versus fed status.
Gender:
MALE
Ages:
Between 18 years and 49 years
Trial Updated:
05/29/2018
Locations: Scintipharma, Inc., Lexington, Kentucky
Conditions: Seasonal Influenza Preventative Vaccine Pharmacodynamics
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
Completed
Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective immune response to kill tumor cells. The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial definitive therapies.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
03/11/2018
Locations: Commonwealth Cancer Center, Danville, Kentucky +3 locations
Conditions: Non-Small Cell Lung Cancer
Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age
Completed
The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.
Gender:
ALL
Ages:
50 years and above
Trial Updated:
09/26/2017
Locations: Central Kentucky Research Associates, Lexington, Kentucky
Conditions: Influenza
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
Completed
Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) \[a mostly T cell-independent humoral response\] and meningococcal polysaccharide dipht... Read More
Gender:
ALL
Ages:
Between 18 years and 55 years
Trial Updated:
05/01/2017
Locations: Research Site, Lexington, Kentucky
Conditions: Relapsing Forms of Multiple Sclerosis
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
Completed
RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells may make the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
Gender:
ALL
Ages:
Between 18 years and 80 years
Trial Updated:
03/30/2017
Locations: Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky
Conditions: Lung Cancer