Showing 26–50 of 200 documents
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National Institute of Allergy and Infectious Diseases (NIAID)
A nonrandomized, open-label trial will be conducted with a total of 64 healthy male and non-pregnant females, ages 18-45 years. Participants in Group A will enroll 32 participants to receive 2x10\^6 colony- forming units CFU TICE(R) BCG vaccination on Day 1 and 4x10\^6 CFU challe…
Helen McShane
…erience with recombinant fowlpox viruses in Oxford Three FP vaccines encoding different malaria antigens have been used so far in clinical trials in Oxford, FP9 ME-TRAP, FP9 CS and FP9 PP. To date 87 doses of FP9 ME-TRAP have been given to 55 volunteers in Oxford using various re…
Helen McShane, MD and PhD
This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis). This vaccine is delivered intrdermally by a needle injection in healthy volunteers. 1. This is a phase I study…
Helen McShane, MD and PhD
This is a phase I study to test the immunogenicity of a recombinant vaccine based on Modified Vaccinia Ankara (MVA) expressing the antigen 85A (from Mycobacterium tuberculosis). This vaccine is delivered intradermally by a needle injection in healthy volunteers previously vaccina…
Isaquel Silva, Sebastian Nielsen, Peter Aaby, Christine Stabell Benn, Frederik Schaltz-Buchholzer
**BACKGROUND:** Within a randomised controlled trial providing Bacillus Calmette-Guérin, measles vaccine, or placebo to women of fertile age, we aimed to study the risk of adverse events following vaccination. This study addresses the lack of data on adverse reactions in adu…
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…
Anne Margarita Dyrhol-Riise, PhD
…itors (COX-2i) can improve the immune system and strengthen vaccines responses. Hypothesis 1. A hyperactive COX-2/PGE2 signal system in active TB causes down-regulated immune responses that favour TB survival, but this can be abrogated by COX-2i. 2. TB-specific immunisation wit…
Gavin Churchyard, PhD, Rasmus Mortensen, PhD
Tuberculosis (TB) is an infection caused by bacteria passed from one person to another through the air when an infected person for instance coughs, speaks, or sneezes. This study tests the safety and vaccine-induced immune response of a new preventive TB vaccine called H107e/CAF®…
Helen I McShane, MBBS, MRCP, BSc, PhD, Adrian VS Hill, MA, BM BCh, DPhil, DM
…the future design and modification of other T-cell inducing vaccines. Group 1 (Immune responses only) Previous human studies of MVA85A have described the immune response to vaccination at fixed timepoints but not in between. The investigators will vaccinate four volunteers and …
Zhongkai SHI, MD, Jan Andersson, MD
Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females. This ia a Phase I, randomized, placebo-controlled, double-blind study in three groups of hea…
Naomi E. Aronson, MD, Merlin L. Robb, MD
The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high or moderate burden of TB. BCG will be compared with a pla…
Stephen Spector, MD, Amaran Moodley, M.D
…ine efficacy has prompted investigators to develop novel TB vaccines and to experiment with enhancing the immune response to the current BCG vaccine. Increasing data indicate that children with low vitamin D levels and specific genetic variants that lower functional levels of vi…
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…
Jinhee Lee, DVM, PhD, Jae Chol Choi, MD, PhD, Youngmok Park, MD, PhD, Kwang Joo Park, MD, PhD, Jinsoo Min, MD, PhD
The purpose of this study is to evaluate the safety and explore the immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in the Bacillus Calmette-Guérin (BCG)-vaccinated older adults aged 55 to 74 with negative or po…
Zhaolin Huang
…afety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm deltoid muscle intramuscularly in the double negative population. Thirty (PPD-QFT-) healthy adult subjects aged 18-45 were selected and divided into placebo group, low-dose adjuvant group, and l…
Álvaro H Borges, Marisa Russell, Dereck Tait, Thomas J Scriba, Elisa Nemes, et al.
**BACKGROUND:** People with tuberculosis who complete treatment remain at risk of recurrent disease. The vaccine H56:IC31 has been shown to be safe and immunogenic in phase 1 and 2 studies, but whether it can reduce the risk of tuberculosis recurrence is unknown. **METHODS:** In…
Daniel Hoft, PhD
…mulated and tested regarding what new and more effective TB vaccines should target for optimal protective immunity. This is an open-label protocol in up to 15 healthy adults who are BCG-naïve. All participants will receive a total of two doses of BCG, by intradermal injection, a…
Doug Walsh, MD
The available live tuberculosis vaccine Bacillus Calmette-Guérin (BCG) provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "booster", while not toxic, does not provide much additional protection. AERAS-402 presents tuberculos…
Bethou Adhisivam, Chinnathambi Kamalarathnam, B Vishnu Bhat, Kumutha Jayaraman, Siva P Namachivayam, et al.
**OBJECTIVE:** To test the effect on all cause neonatal mortality (aged ≤28 days) of a dose of BCG Danish vaccine and oral polio vaccine (OPV) administered to newborn babies weighing <2000 g. **DESIGN:** Multicentre, open label, randomised controlled trial SETTING: Three …
GSK Clinical Trials
…given only to subjects receiving the candidate tuberculosis vaccines and not to the subjects receiving active comparators or control. The safety and immunogenicity of 2 antigen doses in PPD-negative adults will be evaluated. In addition, 2 active comparator groups of volunteers …
Tjip S van der Werf, MD PhD
Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIa trial to evaluate safety and immunogenicity of RUTI® vaccine in Multidrug-resistant Tuberculosis (MDR-TB) patients favourably responding to standard MDR-TB treatment. Time point of vaccinati…
Helen McShane, Professor
The purpose of this study is to evaluate the human clinical response to BCG challenge in historically BCG-vaccinated healthy adult volunteers. It will involve 12 participants in a controlled dose escalation. Bronchoscopies will be performed 14 days post-challenge to measure BCG r…
Tao Huang, Bachelor
The safety, tolerability and immunogenicity of lyophilized recombinant tuberculosis vaccine (AEC/BC02) were studied in a randomized, blind, controlled phase ⅱ A clinical study in patients 18 years and older with latent infection of Mycobacterium tuberculosis.Twenty patients with …
Julie Odgaard Vedel, Oides Furtado, Laerte Lima Almeida, Jailson Sydenei Dias Martins, Sanne Møller Thysen, et al.
**BACKGROUND:** A correct vaccination technique is important for developing BCG scars. Having a BCG scar is associated with lower mortality among BCG-vaccinated children. **AIM:** To compare BCG-scar prevalences among children vaccinated before and after refresher training in BC…
Helen McShane
Boost vaccinations sometimes have no effect because the body has got used to the vaccine and no longer reacts to it. We are therefore investigating whether vaccinating with aerosolised MVA85A (a candidate tuberculosis vaccine) followed by a boost MVA85A intradermal vaccination (o…