Showing 1–19 of 19 documents
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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.
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.
…rin 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 incidence, severity and clinical progression to severe COVID-…
Helen McShane
This is a human pilot study of 16 healthy BCG-naïve volunteers to quantify BCG from the BCG vaccination site. Volunteers will be vaccinated with BCG. The first 8 will go on to have a punch biopsy and suction blister of the vaccination sites at 2 weeks post vaccination (arm A) the…
Helen McShane
…nd highly immunogenic in mycobacterially naïve individuals, BCG vaccinated individuals and M.tb latently infected individuals. We will use the same vaccination regime in this study. Participants will be defined as being infected with M.tb.if they have a positive Elispot response …
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 …
Helen McShane
This study is preliminary to proving that this vaccine could protect against tuberculosis in humans. Although there is no proven data to show that infants will benefit directly from participation in this study by being protected against TB, MVA85A protection of mice, guinea pigs …
Angelique Kany Kany Luabeya, Virginie Rozot, Claire Imbratta, Frances Ratangee, Justin Shenje, et al.
**BACKGROUND:** An effective adult vaccine is needed to control tuberculosis. We evaluated the safety and immunogenicity of a live-attenuated Mycobacterium tuberculosis vaccine (MTBVAC). **METHODS:** This single-centre, phase 1b-2a, double-blind, dose-escalation, randomised cont…
Ahmed Mohamed Dirie, Nor Afiah Mohd Zulkefli, Salmiah Md Said, Ahmed Zaid Fatah Azman, Kassim Abdi Jimale, et al.
… 12 to 23 months receive the Bacillus Calmette-Guérin (BCG) vaccine in Somalia, which helps prevent TB-disseminated diseases. Among the major factors that contribute to poor BCG uptake and TB prevention practices are the lack of maternal knowledge, negative attitude, and poo…
Helen McShane
…aring two different strains of the Bacille Calmette-Guérin (BCG) vaccine at standard and high dose. Currently, to assess vaccine efficacy against tuberculosis (TB) there is no alternative to large randomized controlled trials. These efficacy trials for novel TB vaccines are diff…
Professor Helen McShane, Professor Paul Moss
…linical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive UK adults. The trial will also look to evaluate and compare the amount of BCG recovered from the lungs and from the skin, following challenge …
Helen McShane, Gregory Hussey
This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogenic in a wide range of subjects in previous clinical trials. In this trial,we will…
Mark Hatherill
…oject is to demonstrate safety, immunogenicity and improved efficacy of the new live attenuated M. tuberculosis vaccine called MTBVAC in a Phase 3 efficacy trial in HIV-uninfected infants born to HIV-infected and HIV-uninfected mothers as compared to standard of care BCG vaccinat…
GSK Clinical Trials
…s who are PPD-positive either via previous vaccination with BCG and/or conversion to PPD positivity through exposure to Mycobacterium tuberculosis. The BCG vaccine has been widely available for several decades. It is easy and cheap to produce, and when given to neonates or young…
Dereck Tait, MD
…is clinical trial will evaluate safety, immunogenicity, and efficacy (prevention of Mtb infection as measured by IGRA conversions) of H56:IC31 in remotely BCG vaccinated adolescents. This clinical trial will evaluate safety, immunogenicity, and prevention of Mtb infection, (meas…
Mark Hatherill, MD
… Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents This Phase II, randomized, 3-arm, placebo controlled, partially blinded, clinical trial will be conducted in 990 healthy, HIV-uninfected, QFT-GIT negative, previously BCG vaccina…
Helen McShane
…he safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route in healthy adult individuals who have been previously vaccinated with Bacillus Calmette-Guerin (BCG). We postulate that the intramuscular …
International AIDS Vaccine Initiative
…blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in adolescents and adults aged 14-45 years, living in a TB endemic region. Phase 2b, double-blind, randomized, pla…
Mada Ferreira, MD
…f a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas. The new vaccine should be at least as pote…
Michele Tameris, MD
…TBVAC in South African newborns. Ninety-nine HIV unexposed, BCG naïve newborns will be randomized to receive either BCG 2.5 x 105 CFU (n=24) or MTBVAC at one of three dose levels (n=75). Allocation will be double blind. Enrolment will be sequential into 3 cohorts of increasing MT…