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A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected healthy volunteers.
The study will be conducted in 2 phases. Phase A: Study design contains 6 cohorts, each containing 8 subjects. Three cohorts (24 subjects) will be H. pylori-negative and 3 cohorts will be H. pylori-infected. Subjects fulfilling the inclusion criteria will be assigned to one of 3 sequential dose cohorts with a 3:1 randomisation to IMX101 or to CTA within each cohort.
Phase B: Two cohorts with H. pylori-infected subjects can be expanded up to 20 subjects in each cohort. The decision whether to expand the cohorts will be taken by the Sponsor and the DSMB, as soon as the results of the safety and efficacy analyses are available.
Up to 72 subjects collectively in Phases A & B will be recruited. depending on immunogenicity status.
CTA control, IMX101 vaccine
Published on BioPortfolio: 2017-09-04T22:02:16-0400
This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine
The patients who accept the quadruple eradication program of the helicobacter pylori and success to eradicate helicobacter pylori will be followed-up to observe the situation of re-infecti...
The antimicrobial resistance of helicobacter pylori in Shandong province was analyzed by helicobacter pylori antibiotic sensitivity test.And the map of antimicrobial resistance of helicoba...
The combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter pylori eradica...
The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobact...
HLA-I associated HIV adaptation is known to negatively impact disease progression and CD8 T-cell responses. We aimed to assess how HLA-I associated adaptation impacts HIV vaccine-induced CD8 T-cell re...
The test negative design is validated in outpatient but not inpatient studies of influenza vaccine effectiveness. The prevalence of chronic pulmonary disease among inpatients may lead to nonrepresenta...
Rubella is a vaccine preventable infection, and congenital rubella the most feared complication of this disease. Although young adult women are at greatest risk of post-vaccine rubella, this is also ...
Clarithromycin resistance is the most common cause of Helicobacter pylori treatment failure and it is attributed to three point mutations: A2142G, A2142C and A2143G within 23S rRNA gene. We aimed to d...
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Infections with organisms of the genus HELICOBACTER, particularly, in humans, HELICOBACTER PYLORI. The clinical manifestations are focused in the stomach, usually the gastric mucosa and antrum, and the upper duodenum. This infection plays a major role in the pathogenesis of type B gastritis and peptic ulcer disease.
A species of HELICOBACTER commonly associated with STOMACH DISEASES in FERRETS.
A spiral bacterium active as a human gastric pathogen. It is a gram-negative, urease-positive, curved or slightly spiral organism initially isolated in 1982 from patients with lesions of gastritis or peptic ulcers in Western Australia. Helicobacter pylori was originally classified in the genus CAMPYLOBACTER, but RNA sequencing, cellular fatty acid profiles, growth patterns, and other taxonomic characteristics indicate that the micro-organism should be included in the genus HELICOBACTER. It has been officially transferred to Helicobacter gen. nov. (see Int J Syst Bacteriol 1989 Oct;39(4):297-405).
A species of HELICOBACTER that colonizes the CECUM and COLON of several strains of MICE, and is associated with HEPATITIS and carcinogenesis.
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
Peptic Ulcer Disease
Peptic Ulcer Disease - stomach ulcer, duodenal ulcers used to refer to all types of peptic ulcers. A peptic ulcer is an erosion in a segment of the Gastrointestinal (GI) muscularis mucosae, typically in the stomach (gastric ulcer) or the first few cent...