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H.pylori vaccines · 1 trial · 1 indication
The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo). Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT).
To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local\* and systemic adverse events.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| H.pylori vaccines | BIOLOGICAL | 1 dose of H.pylori vaccine at 0, 1, and 2 months |
| Placebo Vaccine | BIOLOGICAL | Placebo Vaccine at 0, 1, and 2 months |
Inclusion Criteria: * adults 18 - 40 years of age in good health * HP uninfected * not pregnant and agree to use birth control throughout the study (females who can become pregnant) Exclusion Criteria: * remote or current HP infection
H.pylori vaccines is an investigational vaccine being developed for the prevention of Helicobacter pylori infection. It is currently in Phase 1 clinical development and is not yet approved for use. The vaccine is intended for use in adults who are H. pylori-negative.
H.pylori vaccines is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in Phase 1 clinical development for the prevention of Helicobacter pylori infection.
H.pylori vaccines is in Phase 1 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. A Phase 1 clinical trial has been completed to evaluate its efficacy and safety in H. pylori-negative adults.
H.pylori vaccines has one completed Phase 1 clinical trial, identified as NCT00736476. This trial, titled 'Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults,' enrolled 63 participants in Germany. The study was placebo-controlled and included healthy volunteers aged 18 years and older.
H.pylori vaccines is classified as a monoclonal antibody modality, though it is being developed as a vaccine for Helicobacter pylori infection. It is currently in Phase 1 clinical development and is not yet approved for use.