Showing 76–100 of 200 documents
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Ann M Ginsberg, MD PhD
Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on Study Days 0 and 28. Subjects were followed for a total of 98 days. This was a double-blind, rando…
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 …
Marina Stukova, Dr
The aim of the study is to investigate immunogenicity and safety of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years Study includes 160 participants aged 18 to 50, randomized at 3:1 ratio, to…
James Kublin, MD, MPH
…mycobacterial agents and/or protective immunity elicited by vaccines or host-directed therapy. The trial will illuminate the nature of local and systemic immune responses to BCG and treatment response, as well as demonstrate our local capacity for newer, more innovative study des…
Noah Lecthzin, MD, MHS
This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers. This single-site, open-label clinical trial to investigate the immune effects of BCG…
Serum Institute of India Pvt. Ltd.
This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be administered to calculate efficacy of the vaccine against TB recurrence. The study is designed as a …
Randeep Guleria, Prof
Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIb trial to evaluate efficacy of RUTI® vaccine in DS- (Drug-Sensitive) and MDR-TB (Multidrug-resistant) patients favourably responding to standard MDR-TB treatment. Time point of vaccination st…
Ramon Andrade de Souza, Florisneide Rodrigues Barreto, Carla Cristina Oliveira de Jesus Lima, Marcio Santos da Natividade, Carlos Antônio de Souza Teles Santos, et al.
**BACKGROUND:** Can vaccination with Bacille Calmette-Guérin prevent clinical progression of COVID-19? Data from the BCG-REVAC trial was archived in a database, creating an excellent opportunity to link it to notified cases of COVID-19 to evaluate the efficacy of BCG against…
Achim Hoerauf, Prof. Dr.
Filarial nematodes modulate the host immune response to promote regulatory and T helper type 2 immune responses, which were shown to influence concomitant infections. Indeed, several studies showed that increased susceptibility and worsened disease course of HIV, tuberculosis (TB…
Oscar Buisan, Pol Servian, Sonia Pedreño-Lopez, Joan Pagès, Victor Urrea, et al.
Intravesical bacillus Calmette-Guérin (BCG) is the standard treatment for high-risk non-muscle-invasive bladder cancer (NMIBC); however, recurrence and progression remain major challenges. To explore a heterologous prime-boost strategy, we conducted the RUTIVAC-1 trial (NCT0…
GSK Clinical Trials
…tantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.
C. Fordham F von Reyn, MD
A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients. The purpose of this study is to evaluate the safety and effectivene…
GSK Clinical Trials
The purpose of this study is to evaluate the protective efficacy of two doses of GSK Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because pulmonary TB…
Helen McShane
This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects.
Helen McShane
This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A vaccination with and without MVA85A boost in healthy BCG vaccinated adults.
C Fordham von Reyn, MD
DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed with BCG to determine if immunization reduces the risk of TB infection DAR-901 whole cell booster vaccine to prevent TB infection in adolescents ("DAR-PIA") This is a Phase II, 3-injection…
Research Institute for Biological Safety Problems
The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L tuberculosis vaccine versus matched placebo in BCG-vaccinated healthy adult subjects aged 18-50 years.
Franco Piazza, MD, MPH, Anna Marie Beckmann, PhD
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis. The vaccine, identified as ID93 + GLA-SE, consists of the recombinant four-…
Birgit Thierry-Carstensen, David JM Lewis, MD
A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or swelling at the injection site, while a negative test …
National Institute of Allergy and Infectious Diseases (NIAID)
This is a phase I randomized, double blind clinical trial designed to evaluate the safety, tolerability and immunogenicity of the ID93 recombinant protein antigen alone or formulated with GLA-SE or AP10-602 adjuvant in 70 healthy adults 18-49 years of age. Subjects will receive a…
Woo Joo Kim, M.D, Ph.D
Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally. Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally. Tuberculin Skin Test(TST) will be conducted after 84+7 days after IP injection and TST result will be read in 48\~72 hours.
Berik M Khairullin, PhD
The study is a single centre, phase I, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.
Gregory Hussey, FCCH, Larry Geiter, PhD
An open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, in the prevention of tuberculosis during the first two years of life. This is an…
GSK Clinical Trials
The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human Immunodeficiency Virus (HIV)-positive adults aged 18 to 59 years, living in a tuberculosis endemic region. Su…
GSK Clinical Trials
This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.