Showing 126–150 of 200 documents
Sorted by hybrid relevance (keyword + semantic via RRF)
Helen McShane, MD and PhD
A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian volunteers Study Design: The study is a non-randomized clinical trial. Twelve volunteers will be recruited. They would be given 5x107 pfu of the MVA85A vaccine intradermally. The subjects will be requi…
Helen McShane
…ne the cogency of this effect, as potential BCG replacement vaccines must be non-inferior to BCG in this regard. There is a plausible rationale that BCG, a replicating mycobacterium, is capable of inducing non-specific innate immunity, which could induce protection against disea…
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…
Helen McShane
…mized controlled trials. These efficacy trials for novel TB vaccines are difficult, long and very costly. For this reason there is an urgent need for a valid, reliable, and strong correlate of protection which can help distinguish between candidate TB vaccines undergoing phase I …
Greg Hussey, Professor
This study is designed to evaluate the safety of MVA85A in healthy volunteers in Cape Town. We have shown that MVA85A is safe and immunogenic in both a mycobacterially naïve population in the UK and in a more mycobacterially exposed population in The Gambia. The studies described…
Alexander C Schmidt, Lee Fairlie, Elizabeth Hellström, Angelique Luabeya Kany Kany, Keren Middelkoop, et al.
**BACKGROUND:** In a previous phase 2 trial, bacille Calmette-Guérin (BCG) revaccination was not shown to provide protection from primaryinfection but prevented sustainedinfection, defined by an initial conversion on a QuantiFERON-TB (QFT) test (an interferon-release assay) …
Philip C Hill, MPH FRACP, Roger H Brookes, PhD, Richard A Adegbola, PhD FRCPath
There are new TB vaccines already developed that need to be tried in humans to assess their efficacy. The researchers had previously shown that production of interferon gamma by T cells in response to TB antigens is a more specific marker of TB infection. The researchers hypoth…
Hennie Geldenhuys
The study is designed to test the hypothesis that BCG administration via jet injector will produce a comparable immune response and that there will be no significant differences in safety or reactogenicity between BCG administration via jet injector and needle and syringe. The p…
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…
Alison Connor, PhD
Previous studies have shown that a small incentive can have a large impact on health behaviors like vaccinating children. New Incentives, an international non-governmental organization (NGO), aims to boost demand for immunization by offering cash incentives to caregivers who have…
Robert Walker
…. Efforts to increase TB protection in children include new vaccines for primary immunizations as well as combinations of vaccines given as primary and boosting vaccinations. AERAS 402 is a live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion …
Michele Tameris, MD
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI or MTBVAC at equivalent dose (5x10E05 CFU/0.1mL) (n…
Ann Ginsberg, MD, PhD, Avy Violari, MD
…404 or placebo will be administered without concomitant EPI vaccines (Cohorts 1 to 5, N = 159 subjects) and with concomitant EPI vaccines (Cohort 6, N = 70 subjects). Study vaccine or placebo will be administered as a single dose (injection) at Study Day 0 ( ≥168 to ≤ 196 days of…
Marissa Russell
This is a phase 2, double-blind, randomized (1:1), placebo-controlled trial with two parallel groups. * H56:IC31 (investigational vaccine) * Placebo 900 HIV-negative adults with a diagnosis of drug susceptible pulmonary TB are planned to be included, recruited from TB clinics…
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…
Linda-Gail Bekker, MD, Jim Kublin, MD
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to provide leads for biomarkers of protection against 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…
Chengdu CoenBiotech Co., Ltd
This study is a randomized, blinded, active-controlled clinical trial to evaluate the effectiveness and safety of EEC in the diagnosis of Mycobacterium tuberculosis infection in people aged 3 years and above. Methods: In study 1, the marketed recombinant Mycobacterium tuberculos…
Dereck Tait, MD
This 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, (me…
Ahmed Mohamed Dirie, Nor Afiah Mohd Zulkefli, Salmiah Md Said, Ahmed Zaid Fatah Azman, Kassim Abdi Jimale, et al.
**BACKGROUND:** Tuberculosis (TB) in children is one of the most significant public health crises in Somalia. This issue is aggravated by the fact that only 36.7% of children aged 12 to 23 months receive the Bacillus Calmette-Guérin (BCG) vaccine in Somalia, which helps prev…
Sophia B Siddiqui, M.D.
This study, conducted at the University of Mali in the capital city of Bamako, will investigate how the body reacts to infection with Mycobacterium tuberculosis (MTB), the organism that causes tuberculosis. Tuberculosis is a major global health problem whose solution requires dev…
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…
Andreas Schrödter, MD
Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against TB for residents in endemic areas and persons at risk in non-endemic areas. The new live vaccine VPM1…
Giuseppe Pantaleo, MD
70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose (N=30) regimen, or placebo (N=10). Subjects were vaccinated on Study Days 0, 56, and 231, and fol…
Vanya Dhagat, MD
This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of tuberculosis infection. The study will be conducted at one clinical research site in India. The av…