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helicobacter pylori vaccine

Phase 1

Helicobacter Pylori | Monoclonal antibody | Oncology |Novartis AG|Last Updated: Jun 11, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment113

FDA Designations

No designations recorded

Clinical trial landscape

helicobacter pylori vaccine · 1 trial · 5 indications

Phase 1 1
NCT00613665Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy AdultsHelicobacter Pylori
COMPLETED113 Analytics
PHASE1COMPLETED
Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults
Helicobacter PyloriUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety measures: injection site and systemic reactions
5 months

Secondary Endpoints

Immunogencity measures: antigen-specific antibodies and cellular immune response
5 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5PLACEBO_COMPARATOR -
6EXPERIMENTAL -
7EXPERIMENTAL -

Interventions

NameTypeDescription
helicobacter pylori vaccineBIOLOGICALExperimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly
PlaceboBIOLOGICALNine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy * Ages 18-40 * Negative for H. pylori infection * Contraception for females Exclusion Criteria: * Present or past H. pylori infection * Medically significant gastroduodenal disease * Recent corticosteroid use * Bleed diathesis * Use of antibiotics used to treat H. py...

Countries:Germany
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Frequently asked questions about helicobacter pylori vaccine

What is the Helicobacter pylori vaccine used for?

The Helicobacter pylori vaccine is an investigational vaccine being developed for the prevention of Helicobacter pylori infection, which is associated with conditions such as gastritis, gastric cancer, gastroduodenal ulcers, and lymphoma. It is currently in Phase 1 clinical development and has not been approved for use.

Who makes the Helicobacter pylori vaccine?

The Helicobacter pylori vaccine is being developed by Novartis AG, which trades under the ticker NVS. The vaccine is currently in Phase 1 clinical development and is not yet approved for commercial use.

What phase is the Helicobacter pylori vaccine in?

The Helicobacter pylori vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the vaccine is not currently in active clinical trials.

What clinical trials is the Helicobacter pylori vaccine in?

The Helicobacter pylori vaccine has been studied in one completed Phase 1 clinical trial, identified as NCT00613665. This trial, titled 'Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults,' enrolled 113 participants in Germany and evaluated the vaccine's safety and immunogenicity.

Is the Helicobacter pylori vaccine a monoclonal antibody?

The Helicobacter pylori vaccine is classified as a monoclonal antibody modality, though it is designed to prevent Helicobacter pylori infection. It is an investigational vaccine in Phase 1 clinical development and is not yet approved for use.