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helicobacter pylori vaccine

Phase 1

Helicobacter Pylori | Vaccine | Oncology |Novartis AG|Trials Updated: Jun 11, 2013

helicobacter pylori vaccine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2008

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

helicobacter pylori vaccine clinical trials

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?

The Helicobacter pylori vaccine is an investigational vaccine developed by Novartis AG (ticker NVS) for Helicobacter pylori infection. It is designed to prevent or treat H. pylori, a bacterium linked to gastritis, gastroduodenal ulcers, gastric cancer, and lymphoma. The vaccine is in Phase 1 clinical development.

What is the Helicobacter pylori vaccine used for?

The Helicobacter pylori vaccine is being developed for Helicobacter pylori infection and associated conditions, including gastritis, gastric cancer, gastroduodenal ulcers, and lymphoma. It is intended to prevent or treat these conditions by targeting the H. pylori bacterium. The vaccine is investigational and not approved for use.

Who makes the Helicobacter pylori vaccine?

The Helicobacter pylori vaccine is developed by Novartis AG, which trades under the ticker NVS. The vaccine originated from Chiron's investigational program, as referenced in the Phase 1 trial title. Novartis is the company responsible for its development.

What phase is the Helicobacter pylori vaccine in?

The Helicobacter pylori vaccine is in Phase 1 clinical development. It has completed one Phase 1 trial with 113 participants. As an investigational vaccine, it has not been approved by the FDA or any regulatory agency for commercial use.

What clinical trials is the Helicobacter pylori vaccine in?

The Helicobacter pylori vaccine has been studied in one completed Phase 1 trial, NCT00613665, titled "Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults." The trial enrolled 113 healthy adult volunteers in Germany and was randomized and placebo-controlled.