Showing 51–75 of 200 documents
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Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study to assess the safety, reactogenicity and immunogenicity in healthy, BCG vaccinated adults. Participants will be randomized in two groups (in 3:1 ratio -vaccine : placebo) to receive two doses of either Ga…
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 …
Jing-Xin Li, PhD, Li-mei Zhu
This is a randomized, double-blind, parallel-controlled study, for evaluation of safety and immunogenicity of three doses of an inactivated COVID-19 vaccine (CoronaVac) in pulmonary tuberculosis patients aged 18-75 years. 200 tuberculosis patients and 40 healthy adults aged 18-75…
Helen McShane
…will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other. The trial will assess the safety of both vaccines and also their abili…
Nicole L Messina, Laure F Pittet, Emily K Forbes, Kate L Francis, Kaya Gardiner, et al.
**BACKGROUND:** Respiratory tract infections (RTI) are among the leading causes of hospitalisation and death for children under 5 years. We aimed to determine if neonatal BCG vaccination reduces early life hospitalisations for lower RTI (LRTI) in a low-tuberculosis endemic s…
Helen McShane, Professor
The study will commence with a dose-escalation and age de-escalation study in healthy adults and adolescents from the previous Entebbe Mother and Baby Study (EMaBS) in Entebbe, Uganda, focusing on ChAdOx1 85A, to provide safety data for ChAdOx1 85A in this population. These measu…
Abdul M Kazi, MBBS,MPH
Routine childhood immunization (RCI) in Pakistan is well below the recommended coverage of 90% with rates as low as 16% in certain regions (Pakistan DHS 2012-3). This has led to continued polio transmission, large measles outbreaks and thousands of deaths from vaccine-preventable…
Helen McShane
This is a phase I study that will compare the 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 (…
Helen McShane, MD and PhD
This is a phase I study to examine the safety and immunogenicity of MVA85A delivered intradermally into the deltoid region in volunteers who have recieved BCG in the past 20 years. This is a phase I study to examine the safety and immunogenicity of MVA85A delivered intradermally…
Helen McShane, Souleymane Mboup
This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are infected with HIV. It is designed to study the safety and immunogenicity of the vaccine. This study is designed to evaluate the safety of MVA85A in healthy volunteers in Senegal who are …
GSK Clinical Trials
…ajor effort has been made to try to develop new alternative vaccines. One such candidate, Mtb72F/AS02A, is a polyprotein derived from two known M. tuberculosis antigens adjuvanted with AS02A. Mtb72F/AS02A is a candidate TB vaccine under development for two indications: prevention…
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 …
Helen McShane
The purpose of this study is to evaluate the BCG 'challenge' model a four-arm study design has been chosen. Twelve subjects will be recruited into each arm of the study. Allocation of BCG-naïve volunteers to either group A or B, and BCG-vaccinated volunteers to either group C or …
Gavin Churchyard, MBBCh, MMED, FCP, PhD, James G Kublin, MD, MPH
This study is being done to test an experimental study vaccine compared to a placebo. The experimental study vaccine is called ID93 + GLA-SE. ID93 + GLA-SE has been used in humans in research but has not been approved for use in medical care. This study will be the first to test …
Dr.V.Krishna Mohan, PhD
Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and adolescents. Phase II, double-blind, randomized, safety…
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…
David JM Lewis, MD
The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M. tuberculosis virus mixed with a toxoid adjuvant, causes untoward adverse reactions when administered to healthy adult vol…
Lisa Marie Cranmer, MD, MPH
The purpose of this study is to assess whether Mycobacterium bovis rBCGΔureC::hly (VPM1002) vaccination and Mycobacterium bovis bacille Calmette-Guérin (BCG) revaccination are safe and immunogenic in pre-adolescents with and without HIV and with and without Mycobacterium tubercul…
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 …
Fiona M Smaill, MB,ChB
This is a phase 1 study, in healthy volunteers who have previously been immunized with bacilli Calmette Guerin (BCG), to evaluate the safety and immune responses that develop in the blood and lungs following the administration by aerosol of a new experimental adenovirus-based vac…
GSK Clinical Trials
This study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine GSK692342 in healthy adults. The study is designed to have a vaccination phase (includes screening, 2 doses of vaccine 1 month apart and follow-up until 1 month post dose 2),…
Laure F Pittet, Dan Casalaz, Susan Donath, Kaya Gardiner, Casey Goodall, et al.
**BACKGROUND:** Bacille Calmette-Guérin (BCG) vaccine, primarily used against tuberculosis, has off-target (non-specific) immunomodulatory effects, including potential protection against recurrences of latent herpes simplex virus (HSV) infections. Recurrent episodes of HSV h…
Helen McShane
This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313 vaccination compared to MVA85A vaccination, in BCG vaccinated adults.
Alemnew F Dagnew, Linda L Han, Kogieleum Naidoo, Lee Fairlie, James C Innes, et al.
**BACKGROUND:** M72/AS01is a recombinant fusion protein vaccine candidate derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A) and AS01adjuvant. We evaluated safety and immunogenicity of M72/AS01in people living with HIV in South Africa. **METHODS:** In this …