Showing 101–125 of 200 documents
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GSK Clinical Trials
This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.
GSK Clinical Trials
This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative adults who have received treatment for TB disease (d…
Marco Salvetti, Professor, Giovanni Ristori, MD
The frequency of auto-immune diseases (including multiple sclerosis) is increasing in industrialised countries. According to an hypothesis which is receiving a wide international credit, this may be due to the fact that the populations of these countries are increasingly less ex…
GSK Clinical Trials
This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA…
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
This is a multicenter, double-blind, randomized (in 1:1 ratio) placebo-controlled study to assess the safety and protective efficacy of the subunit recombinant tuberculosis vaccine GamTBvac against the development of respiratory tuberculosis not associated with HIV infection in v…
GSK Clinical Trials
This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Clinical Trials
This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
Helen McShane, Paul Moss, Marc Lipman, Felicity Perrin
TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis.
Shabir A Madhi, PHD
Prospective, open-labelled study which will enrol 360 participants in four groups of 80 participants including: HIV-uninfected adults without evidence of TB; HIV-infected adults without any evidence of TB; HIV-uninfected adults with concurrent microbiologic confirmed TB, HIV-infe…
Gates MRI
The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents an…
Jaap van Dissel, MD, Prof.
The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB
Gates MRI
The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus infection (HIV).
Jaap van Dissel, MD, Prof.
The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.
Aleksey V. Kazakov, MD, Anastasia G. Samoylova, MD, Valentina A. Aksyonova, Prof.
The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity. Recombinant tuberculosis allergen (RTA) is a recombinant fusion protein CFP10-ESAT6 produce…
Mark Hatherill, MD
The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful completion of TB treatment with confirmed bacteriologic cure, in preparation for a future Phase 2b…
Gavin Churchyard, MD, PhD, Bernard Landry, MPH
This was a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site in South Africa. A total of 26 subjects were randomized 1:1 to receive 2 doses of either AERAS-402 at 3 x 10\^10 vp (N=13) or placebo (N=13) on Study Days 0 and 28. Dose-escalation to a se…
Statens Serum Institut
The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.
Ann M. Ginsberg, MD, PhD
The objective of this protocol is to obtain biological samples through leukapheresis and cryopreservation of cells for the future study, by in vitro assay, of immune responses after one dose of BCG in BCG-naïve healthy adults. This is an open-label protocol in 12 healthy adults …
JongHyun Kim, MD
The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants The study will be conducted in 2 Countries, Korea and Thailand. About 750 subjects will be enrolled to this study. This clinical trial consists of Part 1 to compare the efficacy and…
Helen McShane, Gregory Hussey
…f inducing T cells, e.g. protein/adjuvant combinations, DNA vaccines and recombinant viral vectors, when used alone these delivery systems induce only low-level responses. Heterologous prime-boost immunisation strategies involve immunizing with 2 two different vaccines, each expr…
Helen McShane
…ce strong cellular immune responses in humans using subunit vaccines. DNA vaccines, recombinant viral vectors and protein/adjuvant combinations all induce both CD4+ and CD8+ T cells, however none of these antigen delivery systems induce high levels of antigen specific T cells, wh…
Helen McShane
…-boost immunization strategies involve giving two different vaccines, each encoding the same antigen, several weeks apart. Using a DNA prime-recombinant modified vaccinia virus Ankara (MVA) boost induces higher levels of antigen specific CD4+ and CD8+ T cells than using homologou…
Helen McShane, Professor
The purpose of this study is to: 1. explore whether investigators can make BCG more effective by giving it in a different way. For this, aerosol inhaled BCG will be compared against the conventional BCG injection. 2. explore if there are differences in response to re-vaccination…
Stephen Gordon, MD
…uberculosis (TB). Efforts to come up with new and effective vaccines have not been successful. Partially, the lack of suitable disease models and protection correlates hinders the research of new vaccines. Controlled human infection model studies (CHIM) involve administering dise…
Mark Hatherill
…tries and we hypothesize that live attenuated mycobacterial vaccines will offer better protection to this naïve population compared to adults. The objective of this project is to demonstrate safety, immunogenicity and improved efficacy of the new live attenuated M. tuberculosis …