9 Clinical Trials for Various Conditions
This is an exploratory study in which the investigators will develop a way to identify the cell responses most strongly associated with protection against chlamydia infection. This study is not driven by a hypothesis.
This study may determine whether laboratory studies of people's blood cells, who have received vaccines against H5 influenza, or "bird flu," will help to decide if the vaccines are going to be prevent disease effectively. About 232 people, 18 years and older, enrolled in the studies "A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults" and "in Healthy Elderly Adults" will participate. Participants may be involved in this study for about 14 months. Procedures may include blood draws, physical exams, and medical history reviews.
To compare the performance of the QuantiFERON Monitor assay against existing methodology.
People with sarcoidosis, particularly those with significant lung and/or cardiac involvement, who become infected with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) are likely at increased risk of complications or death from COVID-19. While SARS-CoV-2 vaccines are highly efficacious in preventing COVID-19 in the general population, whether vaccination provides similar protection in people with sarcoidosis is unknown. The investigators hypothesize that people with sarcoidosis develop less robust antibody and cell-mediated immune responses to SARS-CoV-2 vaccination than healthy individuals, both as a consequence of the disease itself and due to treatment with immunosuppressive medications. This hypothesis will be examined by determining levels of anti-SARS-CoV-2 spike protein immunoglobulin G (IgG) antibody (Specific Aim 1) and measuring SARS-CoV-2-specific activation of peripheral blood T cells (Specific Aim 2) following SARS-CoV-2 vaccination in individuals with sarcoidosis treated and not treated with immunosuppressive medications, in comparison to age- and sex-matched healthy controls. For Specific Aim 1, a second-generation anti-SARS-CoV-2 spike IgG assay calibrated against an independent virus neutralization assay will be utilized. The results of this investigation will address a critical gap in the understanding of vaccine responses in people with sarcoidosis. In addition, the study will contribute knowledge needed to inform clinicians' recommendations to sarcoidosis patients regarding risk of infection after SARS-CoV-2 vaccination, and will help lay the basis for future trials to evaluate the possible benefit of vaccine boosters in individuals with poor immune responses to initial vaccination.
Background: COVID-19 is a disease caused by the SARS-CoV-2 virus. It infects the respiratory tract. Some people who get COVID-19 have only mild symptoms. But for others, infection leads to pneumonia, respiratory failure, and, in some cases, death. Researchers want to learn more about any effects that may persist after people recover from COVID-19. Objective: To learn about any long-term medical problems that people who have recovered from COVID-19 might have, and whether they develop an immune response to SARS-CoV-2 that provides protection against reinfection. Eligibility: People age 18 and older who have recovered from documented COVID-19 or were in close contact with someone who had COVID-19 but did not get the infection Design: Participants will be screened over 2 visits. During visit 1, they will answer questions about any symptoms they are having and will be tested for SARS-CoV-2 infection which will involve a nasal swab sample or other FDA approved test. If the test is negative, they will proceed to the second visit, which will include: Physical examination Medical history Mental health interview (which may be recorded if the participant agrees) Chest x-ray (for recovered COVID-19 participants only) Blood and urine tests Pregnancy test (if needed) Lung function test (for recovered COVID-19 participants only) 6-minute walk test (for recovered COVID-19 participants only) Questionnaires about their general and mental health Leukapheresis to collect white blood cells (optional). Participants will be put into 1 of 2 groups: the COVID-19 group or the close contact group. Participants will have study visits every 6 months for 3 years. They will repeat some of the screening tests. Participants in the COVID-19 group may have visits more often if they develop symptoms that suggest re-infection with SARS-CoV-2.
This study will collect blood samples from patients with non-infectious eye inflammatory diseases a spectrum of eye disorders that can produce sight-threatening vision loss. The blood will be analyzed for substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatments. Treatment is not offered under this protocol. Patients 6 years of age and older with an eye inflammatory disease, including non-infectious uveitis, ocular cicatricial pemphigoid, non-infectious scleritis, episcleritis, Stevens Johnson syndrome, Moorens ulcer, peripheral ulcerative keratitis and keratoconjunctivitis sicca, may be eligible for this study. Patients may or may not currently be participating in a treatment trial. Participants will have blood drawn through a needle in an arm vein. More samples may be collected if patients enrolled in another study are scheduled for additional visits. No more than 4 teaspoonfuls of blood will be collected at any one time.
This study will explore the responses of the immune system to infection with HIV and other pathogens and the changes in these responses over time. Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study. Prior to enrollment and yearly thereafter, vital signs, height and weight will be recorded. A medical history will be obtained if relevant to the laboratory research for which the sample will be used. A more extensive history and physical exam is not required but may be performed if deemed necessary by the VRC clinician. A complete blood count will be performed on the day of enrollment and yearly thereafter. Samples will be collected in the following manner: Blood will be drawn from a needle in an arm vein one or more times during the course of the study. From 20 to 150 cc (4 to 30 teaspoonfuls) of blood will be collected at a time. No more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period. Urine and saliva samples will be collected by the volunteer in private. Swab samples will be collected by a nurse or doctor, using a cotton swab to brush inside the mouth. Samples may be used for the following tests: * Hepatitis and other viral screening-This may include screening for different types of viral liver infections, such as hepatitis A, B, C, D, E, or G; for cytomegalovirus (related to the herpes virus); and for varicella zoster virus (responsible for chicken pox in children and shingles in adults). * Genetic testing-DNA in blood cells may be examined for genetic mutations (physical or chemical changes) or deletions (missing pieces) that affect substances involved in the body's ability to mount an inflammatory immune response. Alterations in the genes for some of these substances have been shown to influence HIV infection. * HLA testing-HLA type is a genetic marker of the immune system. Determining HLA type is necessary in order to do certain research studies. Some HLA types have been associated with an increased risk of diseases like arthritis and other rheumatologic problems. HLA testing may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions. * Other laboratory tests as clinically indicated or required for research needs. Some samples collected in this study may be stored for future research.They will be labeled without identifying information. Those with interesting or strongly positive immune responses may be asked to return to the VRC Clinic to provide samples of urine or oral secretions.
After immunization, particularly in older persons, some people are protected from disease by a vaccine and others are not. The investigators believe that this variable response may be due to overproduction of molecules that suppress development of immunity (antibodies and cell mediated immunity). Normally, these molecules are produced to make sure that immunity is regulated in just the right way for the body as a whole, and to prevent autoimmune disease. However, with aging, the immune system may have difficulty in proper immune regulation. Over production of immunosuppressive molecules after vaccination may interfere with the effects of a vaccine. For example when elderly individuals are immunized against zoster with a licensed vaccine, Zostavax, the vaccine is effective in only about 50 to 60%. The investigators will compare blood levels of antibodies, cellular immunity, and immunosuppressive molecules in recipients of Zostavax to see if there is a correlation between development low immunity and high levels of immunosuppressive molecules.
This is a Phase I/II study to determine the safety and immune response of the H1299 cell lysate vaccine mixed with Montanide(R) ISA-51 VG adjuvant, to be administered on the study in combination with Entinostat and Nivolumab in eligible participants with locally advanced esophageal cancers (EsC) following either neoadjuvant chemoradiation therapy (nCRT) or nCRT and surgery. Phase I of the protocol aims to determine the safe dose of the H1299 lung cancer cell lysate vaccine mixed with Montanide(R) ISA-51 VG adjuvant when it is administered in combination with Entinostat and Nivolumab. Phase II of the protocol will focus on assessing the level of immune response in participants receiving the study intervention when the H1299 cell lysate vaccine with Montanide(R) ISA-51 VG adjuvant is administered at the dose level determined in Phase I.