Vaccines Treatment Options in Pittsburgh, PA

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

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 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 study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine. Observational Objectives: * To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups. Read Less

To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to subjects ≥ 60 years of age. To compare the post-vaccination geometric mean titers of antibody (GMTs) to Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the post-vaccination GMTs to the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to subjects ≥ 60 years of age. Read Less

This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers. Primary Objectives: * To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine. * To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine. Observational Objectives: Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination\[s\]) in subjects in the study groups. Immunogenicity: - To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group. Read Less

This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two doses of Menactra® Vaccine. Read Less

Primary objective: To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment. Secondary objectives: Safety: To describe the safety profile in both treatment groups. Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response. Read Less