Showing 1–25 of 50 documents
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Zhou Xing, PhD, Fiona M Smaill, MD
The purpose of this Phase 1 study is to evaluate the safety and immune responses of a new tuberculosis vaccine, Ad5Ag85A, administered to healthy volunteers. 48 subjects will be recruited, 24 who have previously been vaccinated with BCG and 24 who have not received BCG vaccine. T…
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
The study is aimed to evaluate the safety and immunogenicity of the medicinal product "GamTBvac" - a recombinant subunit vaccine against the tuberculosis. The study is designed as a comparative placebo-controlled study with a two-fold increase of an applied dose among healthy vol…
Angelique Luabeya, MD
This is a Phase I, open-label, dose-escalation study with three study groups. This study will be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection (LTBI) and 8 of whom will not have LTBI at study enrollment. The investigational product is A…
Ian Toma, MD, PhD
Maternal infections affect the basal immune status of neonates. One of the possible mechanism is the fetomaternal microchimerism, in which some cells and active substances are exchanged bi-directionally between maternal and fetal circulation through placenta. Even in the absence …
Pere-Joan Cardona, MD, PhD, Joan Costa, MD, PhD
The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI) when administered to healthy adult volunteers, compared to placebo; and determine its safe dosage range. An initial evaluation of immune responses to the vaccine compared to placebo will …
Julio HR Croda, PhD
In the last decade, the incidence of tuberculosis (TB) has declined in much of the world, but has increased in Central and South America. Since 2000, the prison population in these localizations has grown by 206%, the highest increase in the world. In the same period, the reporte…
André S Nell, MD, Pere Joan Cardona, MD, PhD
The aim of the trial is to assess the safety, tolerability and immunogenicity of two doses of RUTI® vaccine administered four weeks apart after one month pre-treatment with INH. The trial will be double-blinded, randomized and placebo-controlled with 96 subjects (48 HIV- and 48 …
Jemal Hussein, MD, Peter Bang, Msc
The study has the following objectives: Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB …
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…
Archivel Farma S.L.
…on, therefore reduce the time required to cure. Therapeutic vaccines do not interfere directly with the causative organism and hence, they are not involved in the development of drug resistance. Therapeutic vaccination would also be beneficial for DS-TB as it could increase the r…
Dereck Tait, MD, Angelique Luabeya, MD
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose le…
Manjula Singh, Sindhu Joshi, Vikram Vohra, Rohit Sarin, Suchit Vasant Kamble, et al.
… in participants with tuberculin skin test positivity. Both vaccines were well tolerated with mild local reactions in about a third of participants. VPM1002 and Immuvac inducedspecific polyfunctional CD4+ T cells. Post hoc analyses showed vaccine efficacy of 64.6% (95% CI 16.3% t…
Shen Gwan Han, MD
Tuberculosis is still the most common infectious disease in Taiwan. The infants in Taiwan have been vaccinated at birth with BCG -Tokyo 171 strain since 1951. The BCG vaccination rate is 97% among first grade students in a recent national survey. Even with such a high BCG vaccina…
National Institute of Allergy and Infectious Diseases (NIAID)
The purpose of this research is to further study the tuberculosis (TB) vaccine, Bacillus Calmette Guérin (BCG). The goal of this study is to evaluate whether the BCG vaccine is more effective in preventing TB in adults if it is given after 6 months of treatment with a widely used…
Ferenc Karpati, MD, PhD
CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete. Initially, healthy volunteers wi…
Francesca Montagnani, PhD, MD
The aim of this project is to analyze the potential contribution of IGRA test QuantiFERON-TB Gold In Tube test (QTF-GIT, Cellestis Limited, Carnegie, Victoria, Australia) in the diagnosis of tuberculosis (TB - active or latent) in pediatric subjects (0 and 17 year)s recently expo…
Sophia B Siddiqui, M.D.
This study will examine how the immune system responds to infection with Mycobacterium tuberculosis bacteria (bacteria that cause tuberculosis) in order to better understand how the germ produces infection and how the immune response might work to control the infection. Only abo…
Li-Ming Huang, MD, PHD
To investigate the size of PPD and TB specific ELISPOT among children between 3m/o and 15 y/o . Calculate the normal range of age specific PPD size in children who recieved BCG at new-born period. Sampling 1. Age under 3 year-old: a targeted population contains 500 children wil…
Queen Mary University of London
…erventions designed to prevent acquisition of LTBI, such as vaccines and programmes of micronutrient supplementation, c) to track spreading of particular strains through a population (providing a tool for public health intervention), d) to discriminate between Mtb-sensitised indi…
Guislaine CARCELAIN, Dr
The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in countries with a high proportion of population having received vaccination with the BCG. We aim to determine the cost-effectiveness of Quantiferon gold (QTFG), compared to BCG vaccine to de…
Angelique Luabeya, MD
MTBVAC at four dose levels: 5 x 10\^3 CFU, 5 x 10\^4 CFU, 5 x 10\^5 CFU, and 5 x 10\^6 CFU. The active control is BCG (5 x 10\^5 CFU). Participants will receive a single dose of MTBVAC or BCG revaccination administered intradermally on Study Day 0. This is a Phase 1b/2a, double-…
Manresana de Micobacteriologia, SL
This is a doble-blind, masked, compared with placebo clinical trial in pediatric population in contact with tuberculosis with or without tuberculosis infection. This trial aims to study the effect of the probiotic Nyaditum resae® at the level of specific Treg memory cells eight w…
Trevor Hansel, FRCPath, PhD, Peter JM Openshaw, FRCP, PhD, FRSB, FMedSci, Robin Shattock, PhD
… In the future, this may allow the testing of new drugs and vaccines, by seeing if they decrease or stop the inflammation after the nasal challenge. STUDY DESIGN AND METHODOLOGY The study involves 3 parts with different nasal spray challenges being administered to subjects: 1.…
Michael Gardam, MD
The tuberculin skin test (TST) has been the gold standard for diagnosing latent tuberculosis for almost 100 years. While this test performs reasonably well in healthy, non-bacille Calmette-Guerin (BCG) vaccinated populations, it is believed to perform less well in patients who do…
Freundeskreis Für Internationale Tuberkulosehilfe e.V
Introduction: The large reservoir of tuberculosis infections is a key driver of sustained tuberculosis (TB) incidence. Accurate diagnostic tests are crucial to correctly identify and treat people with TB infection, which is vital to eliminate TB globally. The Cy-TB skin test and …