Vaccines Treatment Options in Maryland

This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose. Read Less

The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for culture-confirmed) to those contained in the respective annual vaccine formulations. Primary Objective: * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined influenza-like-illnesses (ILI). Secondary Objectives: * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a modified Centers for Disease Control and Prevention (CDC)-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a modified CDC-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a respiratory illness. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a respiratory illness. Read Less

H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying intervals. Read Less

The purpose of this study is to see if cyclosporine, taken when a patient begins highly active antiretroviral therapy (HAART), increases the number of CD4 T-cells (blood cells that fight infection) in a patient's blood. This study also will explore the safety of briefly giving cyclosporine to patients starting HAART. Read Less

The purpose of this study is to compare a new higher-dose influenza virus vaccine to the standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect elderly against viral influenza but not as well as desired. It is expected that the higher doses vaccine can be given with little reaction, but this needs to be tested. Up to 410 people ages 65 years and older will be recruited from the community and from existing volunteer populations. Participants will receive either the high or standard dose injected in the muscle, remain in the clinic for 20 minutes afterward, and maintain a daily memory aid for 7 days. The memory aid will be reviewed by telephone 8-12 days after the injection and return to the clinic or contacted by telephone 6 months after the injection. Read Less

The purpose of this study is to determine the safety and effect of diluting smallpox vaccine, making a larger number of doses in case smallpox is released into the environment. A total of up to 927 healthy adults between the ages of 32 and 70 years who were already vaccinated against smallpox (but not since 1989) will volunteer for this study for up to 34 weeks and receive different strengths of vaccine. Some subjects may participate for longer if they choose to be revaccinated because the first vaccination does not take. The vaccine will be given by making small cuts in the skin and putting the vaccine into these cuts. After the screening visit, volunteers will be followed through study visits and follow up phone calls. Blood will be collected during some study visits to look at the immune system (body system that fights infection) response. Read Less

This protocol is to compare the immune response of different influenza vaccines given by two different routes of administration in healthy adults ages 18 to 64 years. Read Less

This study will evaluate the safety and effectiveness of a new vaccine, ALVAC-pp65, in boosting immunity to cytomegalovirus (CMV) infection in stem cell transplant donors. CMV is a member of the herpesvirus group, which includes herpes simplex virus types 1 and 2, varicella-zoster virus (which causes chickenpox), and Epstein-Barr virus (which causes infectious mononucleosis). Most adults are infected with CMV, but a healthy immune system keeps the virus in check, so that it does not cause harm. In people with a weakened immune system, such as transplant recipients, the virus can become reactivated. Medications for treating the infection may cause low blood counts and kidney damage, and, in some cases, the virus may cause death. The ALVAC-pp65 vaccine is intended to improve immunity against CMV in stem cell donors and thereby prevent its reactivation in recipients. It is made from a virus that ordinarily infects canaries. The virus is weakened so that it cannot infect the person who receives it, and it is modified to carry a copy of a CMV gene called pp65. This gene instructs cells to make CMV proteins that the vaccine recipient's immune system can produce antibodies to, thus conferring immunity to the disease. Persons 18 years of age or older who are scheduled to donate stem cells for a patient in an NIH protocol and who are not allergic to eggs, egg products, or other vaccines, may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests. Participants receive three vaccinations one week apart beginning at least 3 weeks before the scheduled stem cell donation. They are observed for 30 minutes after each vaccination to look for any immediate side effects of the vaccine. Approximately 3 tablespoons of blood are drawn before each vaccination and 1 week after the last vaccination to evaluate vaccine safety. Blood samples are also collected at the screening evaluation, 3 weeks after the start of vaccination, and 3 months after the last vaccination to check for CMV immunity. Participants keep a diary, recording any reactions to the vaccine and any change in medications. They are contacted by telephone for follow-up 3 months after the last vaccination to report any additional symptoms. Read Less

This study will determine the safety and effectiveness of an experimental vaccine in controlling the abnormal growth of cells in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and chronic myeloid leukemia (CML). It will test whether the vaccine can increase the number of immune cells responding to the cancer and thereby slow progression of the illness, improve blood counts, reduce the need for transfusions of blood and platelets, or even achieve a disease remission. The vaccine contains part of a protein that is produced in large amounts by cells of patients with these cancers and an added substance called Montanide that helps the immune system respond to the vaccine. Sargramostim, another substances that boosts the immune response, is also given. Patients 18 to 85 years of age with MDS, AML, ALL or CML may be eligible for this study. Candidates are screened with a medical history, physical examination, blood tests, chest x-ray and bone marrow biopsy. Women of childbearing age also have a pregnancy test. Participants undergo the following: * Chemotherapy entering the study. * Leukapheresis to collect large amounts of white blood cells for infusion before vaccine administration. * Participants may need placement of a central line (plastic tube, or catheter) in the upper part of the chest to be used for giving chemotherapy, blood or platelet transfusions, antibiotics and white blood cells, and for collecting blood samples. * Weekly vaccine injections for nine weeks, given in the upper arm, upper leg or abdomen. * Sargramostim injections following each vaccination. * Standard of care treatment for MDS, AML, ALL or CML, which may include blood or platelet transfusions, growth factors, and drugs to control underlying disease and potential side effects of the vaccine. * Weekly safety monitoring, including vital signs check, brief health assessment, blood tests and observation after the vaccination, on the day of each vaccination. * Follow-up evaluations with blood tests and chest x-ray 3 weeks after the last vaccine dose and with blood tests and bone marrow biopsy 7 weeks after the last vaccine dose. Read Less

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants. Read Less

The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential. Read Less

The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline, Boostrix®) and HPV vaccine (Merck \& Co., Inc., Gardasil®) when administered concomitantly with MenACWY are comparable to responses elicited by these vaccines when given alone. Read Less