Vaccines Treatment Options in Pennsylvania

The investigators hypothesize that the treatment of metastatic colorectal cancer (mCRC) patients with the combination of alpha-type-1-polarized dendritic cell (αDC1) vaccines and tumor-selective chemokine modulation (CKM) will promote the infiltration of vaccination-induced CD8+ CTLs to tumor lesions and subsequently tumor regression with improved patient survival. Read Less

Subjects will receive immunizations every other week for 8 immunizations prior to clinical and immunological evaluations. Patients will then receive immunizations every month up to one year. Cyclophosphamide will be administered intravenously 3 days prior to the first immunization, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations. Women and men \>= 18 years of age with refractory metastatic malignancies that express NY-ESO-1 by RT-PCR or immunohistochemistry. Alternatively, patients may be elected on the basis of serum anti-NY-ESO-!-antibodies as detected by ELISA. Primary Objective: To evaluate the toxicity profile of the regimens described in Section 1.6. Secondary Objective: To detect and quantitate immune responses induced by the proposed peptide vaccine or protein vaccine in association with CpG 7909 and cyclophosphamide. This endpoint will be assessed by an IFN-y ELISPOT assay of NY-ESO-1-specific tumor-reactive CD8 + T cells. We also will look for NY-ESO-1 tetramer CD8+ T cells, Delayed-type Hypersensitivity (DTH), and NY-ESO-1-specific CD4+ T cell responses with ELISPOT assays and cytokine-release-assays. Tertiary Objectives: To evaluate tumor response in terms of clinical tumor regression and progression-free interval. To evaluate the survival of patients treated with the regimens described in Section 1.6. The first 3 patients will be assigned treatment A. All three patients will be treated and observed for one month. If no DLTs are observed in the first 3 patients, accrual to arm A will be put on hold and accrual will continue with Arm B. However, if 1 DLT is observed in Arm A, up to 3 additional patients will be treated on Arm A, until either 2 DLTs have been observed, or 6 patients have been treated with just 1 DLT among them. If 2 DLTs are observed in Arm A, the study will terminate and all treatments will be deemed intolerable. The same principles apply to the cohorts treated on B-E: if the number of DLTs (after one month of treatment) is zero, accrual proceeds to the next treatment group; if it is 1, accrual continues with the same treatment for up to 3 additional patients; if it is 2, no patients will be treated on the remaining treatment arms. Read Less

Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to \< 60 months of age, with 28-day shedding follow-up and 180-day safety follow-up. Read Less

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). Read Less

The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults. Read Less

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age. Read Less

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group. Read Less

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years. Read Less

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 recognize 3 types of sugars called GM2, GD2 and GD3 that are found primarily on the surface of sarcoma cells. If the trivalent vaccine can stimulate the patient's immune system to develop antibodies which recognize and target the GM2, GD2 and GM3 sugars, then the patient's antibodies could attack and kill any remaining sarcoma cells potentially preventing the recurrence of sarcoma. Read Less

The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579). No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Read Less

The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine. Read Less

The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects. Secondary Objectives: Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination. Read Less