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, Milford, Massachusetts
Conditions: Respiratory Syncytial Virus Infections
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
Completed
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
05/21/2018
Locations: The Fenway Institute, Boston, Massachusetts
Conditions: Genital Herpes Simplex Type 2
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, Boston, Massachusetts
Conditions: Herpes Zoster
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
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: The Fenway Institute, Boston, Massachusetts
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: The Fenway Institute, Boston, Massachusetts
Conditions: Genital Herpes Simplex Type 2
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: ActivMed Practices & Research, Methuen, Massachusetts
Conditions: Influenza
Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Terminated
This randomized phase II trial studies how well docetaxel and prednisone with or without vaccine therapy works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and prednisone, 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 an antigen may help the body build an effective i... Read More
Gender:
MALE
Ages:
18 years and above
Trial Updated:
08/21/2017
Locations: Beth Israel Deaconess Medical Center, Boston, Massachusetts
Conditions: Hormone-Resistant Prostate Cancer, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer
A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Completed
This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
07/11/2017
Locations: Dana Farber Cancer Institute, Boston, Massachusetts
Conditions: Rheumatoid Arthritis
Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Terminated
The prognosis for children and adults with acute lymphoblastic leukemia (ALL) has improved significantly over the years. Nevertheless, patients who experience disease relapse or induction failure along with patients having unfavorable genetics \[t(4;11) or t(9;22)\] have dismal prognosis. For these patients, novel therapeutic approaches such as immunotherapy are needed. In this clinical trial, investigators evaluate whether it is feasible to make a vaccine from leukemia cells and whether this va... Read More
Gender:
ALL
Ages:
All
Trial Updated:
06/19/2017
Locations: Massachusetts General Hospital Cancer Center, Boston, Massachusetts +1 locations
Conditions: Leukemia
An Intervention Study To Improve Human PapillomaVirus ( HPV) Immunization in Haitian and African American Girls
Completed
In the United States, Black women are more likely to die of cervical cancer than White women. In developing countries and globally, Haitian immigrant women are more likely to die of cervical cancer than any other women in the world. Studies have shown a disparity in parental acceptance of the HPV vaccine with parents of Black adolescent girls being less likely to accept and comply with HPV immunization schedules than Whites. The objective of this study is to increase HPV immunization rates in Ha... Read More
Gender:
FEMALE
Ages:
Between 11 years and 15 years
Trial Updated:
04/11/2017
Locations: Boston Medical Center, Boston, Massachusetts
Conditions: Cervical Cancer
Trivalent Ganglioside Vaccine With Immunological Adjuvant or Immunological Adjuvant Alone in Metastatic Sarcoma Patients Who Are Rendered Disease Free
Completed
Sarcoma patients are at high risk for their cancer to recur even when the sarcoma has been removed surgically or treated with radiation or chemotherapy. The patients in the study will be randomized (like flipping a coin) to receive either a vaccine that is combined with an immune system stimulant or the immune system stimulant alone. The immune system stimulant is called OPT-821 and is an immunological booster. The trivalent vaccine is being developed to teach the patient's immune system to reco... Read More
Gender:
ALL
Ages:
16 years and above
Trial Updated:
03/14/2017
Locations: Dana Farber Cancer Institute, Boston, Massachusetts
Conditions: Sarcoma