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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
The H.pylori vaccine is an investigational vaccine developed by Novartis AG (ticker NVS) for the prevention of Helicobacter pylori infection. It is a preventive vaccine candidate that has been studied in healthy adult volunteers who tested negative for H. pylori. It remains in clinical development and is not an approved product.
The H.pylori vaccine is being developed for Helicobacter pylori infection, a bacterial infection of the stomach. The clinical program enrolled H. pylori-negative healthy adults, which is consistent with a preventive vaccine approach rather than treatment of existing infection. The vaccine has not been approved for any use.
Novartis AG, which trades under the ticker NVS, is the developer of the H.pylori vaccine. The company sponsored the clinical trial evaluating the vaccine candidate in healthy adult volunteers in Germany. Novartis is a multinational pharmaceutical company headquartered in Switzerland.
The H.pylori vaccine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The vaccine is investigational and has not received FDA approval. Phase 1 studies primarily assess safety and immune response in a small number of participants.
The H.pylori vaccine was evaluated in a single completed Phase 1 trial, NCT00736476, titled Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults. The trial enrolled 63 participants in Germany, was randomized and placebo-controlled, and included healthy volunteers aged 18 years and older.
The completed Phase 1 trial of the H.pylori vaccine, NCT00736476, enrolled 63 participants. The study was randomized and placebo-controlled and was conducted in Germany in healthy adult volunteers who were negative for H. pylori. It was a Phase 1 study, so the enrollment was limited to a small group.