Showing 1–25 of 200 documents
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BioNTech Responsible Person
…aluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule. This study includes: Part A (Phase Ib) and Part B (Phase IIa). In Part A, enrollment for BNT164a1 and BNT164b1 will be cond…
Peter Aaby
The World Health Organization (WHO) currently recommends BCG vaccination at birth in developing countries. Pre-term infants should be vaccinated when they reach the chronological age of 40 weeks. Due to difficulties in establishing the correct gestational age, the vaccination pol…
Yu Hwa Choi
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent. The healthy adolescent will all have had the childhood TB vacci…
Yu Hwa Choi
The purpose of this study is to evaluate the experimental tuberculosis (TB) vaccine called ID93+GLA-SE. The safety, immunogenicity, and efficacy of ID93+GLA-SE will be compared to placebo, after three intramuscular (IM) injections one month apart in healthy healthcare workers. Th…
Helen McShane
The dose of recombinant MVA used in the TB trials to date is relatively low compared with other trials using recombinant MVAs which have used up to 2.5 x 108pfu (A Hill, personal communication). Having demonstrated safety and immunogenicity of 5 x 107pfu of MVA85A, we now need to…
François Spertini, MD
…ion in inducing protection against tuberculosis (TB). Novel vaccines are essential to fight against the current world epidemics in tuberculosis and resistance to anti-TB drugs. A randomized, double-blind, controlled Phase I study conducted at CHUV, Lausanne, Switzerland, to comp…
Tatyana Zubkova
The aim of the study is to investigate safety, reactogenicity and immunogenicity of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years. Study include 51 participants in two cohorts. At the firs…
Helen McShane, Alison Elliot
Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality and morbidity; development of an effective vaccine is a global health priority. Over a billion pe…
GSK Clinical Trials
The purpose of this study is to assess the safety and immunogenicity of two doses of the TB vaccine administered according to a 0, 1 month schedule. In, addition, blood samples collected at different time points after vaccination will be analysed to see when exactly genes are act…
BioNTech Responsible Person
…ill evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule. Enrollment for BNT164a1 and BNT164b1 will be conducted independently, and in parallel. The trial will enroll participants di…
Michele Tameris, M.B.Ch.B.
The purpose of this study is to determine the safety, tolerability, and immunogenicity in BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.
François Nosten, Professor
…pant will receive single or double doses of one of COVID-19 vaccines (Pfizer-BioNTech COVID-19 vaccine, AstraZeneca vaccine or Janssen Ad26.COV2.S COVID-19 vaccine) in the deltoid muscle of the non-dominant arm. Study Duration approximately 1 year. The main focus of this study is…
Helen McShane, Dr
…ce strong cellular immune responses in humans using subunit vaccines. DNA vaccines, recombinant viral vectors and protein/adjuvant combinations all induce both CD4+ and CD8+ T cells, however none of these antigen delivery systems induce high levels of antigen specific T cells, wh…
Helen McShane
…tify a potential correlate of protection. Future candidate vaccines can then be assessed against their capacity to induce such an immune response. Potential risks to human subjects: The general risks to participants in this human pilot study are associated with phlebotomy, vac…
François Spertini
…t" vaccination strategies, in which two different candidate vaccines expressing antigens in common are given weeks or months apart, have generated strong and sustained cellular immune responses correlating with an M.tb protective effect in preclinical animal models. In such a "pr…
Helen McShane
…been immunised with various recombinant MVA investigational vaccines including constructs expressing malaria, HIV, hepatitis B and melanoma antigens without significant adverse reactions (Hill, unpublished data). Furthermore, 190 children aged 1-5 years were vaccinated with a rec…
Helen McShane
…ce strong cellular immune responses in humans using subunit vaccines. DNA vaccines induce both CD4+ and CD8+ T cells and thus offer a potential new approach to a TB vaccine. DNA vaccines encoding various antigens from M. tuberculosis have been evaluated in the murine model, and t…
Ting Huang, Master
…esign. In this trial, 160 subjects were enrolled. The test vaccines are divided into four dose groups: dose group 1 (0.025mg / 0.1ml / person), dose group 2 (0.05mg / 0.1ml / person), dose group 3 (0.075mg / 0.1ml / person), dose group 4 (0.1mg / 0.1ml / person), each Each dose …
Mark Hatherill, MD, FCPaed
…as been excluded. Clinical trials of new viral-vectored TB vaccines, including MVA85A, a modified vaccinia virus Ankara (MVA) vaccine expressing the Mycobacterium tuberculosis antigen 85A, have to date enrolled infants who were already vaccinated with routine BCG at birth. Howev…
National Institute of Allergy and Infectious Diseases (NIAID)
This study will assess the safety of a Bacillus Calmette-Guérin (BCG) vaccine against tuberculosis (TB) and will evaluate if giving the vaccine by mouth, injection, or by both methods produces greater results. BCG vaccine and/or placebo (substance containing no medication) will b…
Ben Morton, MD. MPH, MBChB
…us disease and the body's response and can help develop new vaccines and treatments. The purpose of this study is to set up a human challenge model using BCG to understand how the body responds to this. If our human challenge model works well it may be used to help researchers de…
Shuihua Lu
There are four populations in Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried (AEC/BC02) phase I clinical research. The clinical study adopt open research design. Population I have 25 subjects who received Tuberculin purified protein derivative(TB-PPD) skin test and …
Helen McShane, Professor
The purpose of this study is to: 1. Demonstrate the safety of a novel TB vaccine (ID93/GLA-SE) when given to both BCG-vaccinated and BCG-naïve volunteers. 2. Provide preliminary immunogenicity data of this novel TB vaccine (ID93/GLA-SE). This clinical trial will apply an aeroso…
Dr.V.Krishna Mohan, PhD
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial…
Zhou Xing, PhD, Fiona M Smaill, MD
The purpose of this Phase 1 study is to evaluate the safety and immune responses of a new tuberculosis vaccine, Ad5Ag85A, administered to healthy volunteers. 48 subjects will be recruited, 24 who have previously been vaccinated with BCG and 24 who have not received BCG vaccine. T…