Phase 1 Safety and Immunogenicity of Meningococcal Vaccine
Completed
The purpose of this study is to determine whether a vaccine based on outer membrane vesicles (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a vaccine. If so, the NOMV in this vaccine will be combined with NOMV from two other genetically modified strains as a potentially globally effective vaccine against group B meningococcus.
Gender:
ALL
Ages:
Between 18 years and 45 years
Trial Updated:
12/15/2017
Locations: Clinical Trials Center, WRAIR, Silver Spring, Maryland
Conditions: Meningococcal Infection, Group B
Aldesleukin With or Without Vaccine Therapy in Treating Patients With Stage IV Melanoma
Completed
RATIONALE: Aldesleukin may stimulate the white blood cells to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Giving aldesleukin together with vaccine therapy may kill more tumor cells. It is not yet known whether aldesleukin is more effective with or without vaccine therapy in treating melanoma. PURPOSE: This randomized phase II trial is studying how well aldesleukin works when given with or without vaccine therapy in treating patients with... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
12/03/2017
Locations: Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota
Conditions: Stage IV Melanoma
Influenza Vaccine Post Allogeneic Transplant
Terminated
Study Design: This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.
Gender:
ALL
Ages:
6 months and above
Trial Updated:
12/03/2017
Locations: Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota
Conditions: Hematopoietic Stem Cell Transplant, Hematologic Malignancy
Safety, Immunogenicity and Efficacy Study of Inactivated Whole Cell Shigella Flexneri 2a Vaccine With and Without dmLT in Adults
Withdrawn
This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC) and an adjuvant called dmLT. Sf2aWC is a killed vaccine that is being made to prevent disease from Shigella., which causes bloody, watery diarrhea. An adjuvant is something that is added to a vaccine to make it work better. The purpose of the study is to see if the vaccine will protect people from Shigella infection with or without an adjuvant called dmLT. Abo... Read More
Gender:
ALL
Ages:
Between 18 years and 45 years
Trial Updated:
11/16/2017
Locations: Center for Vaccine Development (CVD), University of Maryland School of Medicine, Baltimore, Maryland
Conditions: Shigella Sonnei Dysenteries
Gemcitabine Hydrochloride, Cisplatin, and AGS-003-BLD in Treating Patients With Muscle-Invasive Bladder Cancer Undergoing Surgery
Withdrawn
This pilot clinical trial studies how well gemcitabine hydrochloride, cisplatin, and AGS-003-BLD work in treating patients with bladder cancer that has spread to the muscle and who are undergoing surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from a person's tumor cells may help the body bui... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
11/14/2017
Locations: Mayo Clinic, Rochester, Minnesota
Conditions: Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma
Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A
Completed
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
11/10/2017
Locations: GSK Investigational Site, Little Rock, Arkansas +10 locations
Conditions: Herpes Zoster
A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART
Completed
GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases. The first phase is the vaccination phase, where patients are vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen. The second phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12 week period approximately 8 weeks following the la... Read More
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
11/09/2017
Locations: The University of Alabama at Birmingham Alabama Vaccine Research Clinic, Birmingham, Alabama +2 locations
Conditions: HIV-1 Infection
Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12
Terminated
The purpose of this study is to test the safety of an investigational Dendritic Cell/Tumor Fusion vaccine given with IL-12 for patients with breast cancer. RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Interleukin-12 may stimulate the white blood cells to kill tumor cells. Giving vaccine therapy together with interleukin-12 may kill more tumor cells. PURPOSE: This phase I/II trial is studying... Read More
Gender:
FEMALE
Ages:
18 years and above
Trial Updated:
10/12/2017
Locations: Beth Israel Deaconess Medical Center, Boston, Massachusetts
Conditions: Breast Cancer
Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults
Completed
The primary objective of this study is to retrospectively characterize the safety of Flublok in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent inactivated influenza vaccines (IIVs), using a methodological approach designed to query the database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern California (KPNC), a large medical care organization (MCO).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
10/11/2017
Locations: Kaiser Permanente Vaccine Study Center, Oakland, California
Conditions: Human Influenza
Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
Completed
This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant. Secondary objectives of the study include: * Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo. * Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvan... Read More
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
10/06/2017
Locations: University of Alabama Vaccine Research Unit, Birmingham, Alabama +15 locations
Conditions: Genital Herpes Simplex Type 2
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
Completed
This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. Objectives: * To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: * Time to first clinical and/or virologic recurrence after Dose 3 (Day 43) * Proportion of subjects who are recurrence free at 6 and... Read More
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
10/06/2017
Locations: University of Alabama Vaccine Research Unit, Birmingham, Alabama +15 locations
Conditions: Genital Herpes Simplex Type 2
Jet Injection for Influenza
Completed
The purpose of this study is to determine if the administration of a seasonal flu vaccine using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and syringe administration, as measured by laboratory tests of immune response.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
09/29/2017
Locations: Poudre Valley Hospital, Fort Collins, Colorado +2 locations
Conditions: Influenza, Human