Helicobacter PyloriPhase 1NCT00613665
Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults
A Phase 1 study testing helicobacter pylori vaccine in people with Helicobacter Pylori and Gastritis, run by Novartis Vaccines at 1 site in Germany.
Trial summary
This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori, Gastritis, Gastric Cancer
- What is being tested?
- helicobacter pylori vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2001to Apr 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Ages 18-40
- Negative for H. pylori infection
- Contraception for females
Who cannot join
- Present or past H. pylori infection
- Medically significant gastroduodenal disease
- Recent corticosteroid use
- Bleed diathesis
- Use of antibiotics used to treat H. pylori infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Randomized, Controlled, Single-blind, Dose-Ranging and Schedule-Finding Study of the Safety, Tolerability, and Immunogenicity of Chiron Helicobacter Pylori Vaccine in Healthy, Helicobacter Pylori-negative Adults
This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine
- Conditions
- Helicobacter Pylori, Gastritis, Gastric Cancer, Gastroduodenal Ulcers, Lymphoma
- Being tested
- helicobacter pylori vaccine, Placebo
- Medical subject headings
- Gastritis, Stomach Neoplasms, Peptic Ulcer, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
helicobacter pylori vaccineBiological
Experimental 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
helicobacter pylori vaccineBiological
Seven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly
helicobacter pylori vaccineBiological
Seven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly
helicobacter pylori vaccineBiological
Eight subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly
PlaceboBiological
Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly
helicobacter pylori vaccineBiological
Nine subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly
helicobacter pylori vaccineBiological
Ten subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: helicobacter pylori vaccine |
| 2 | Experimental | Not described Receives: Biological: helicobacter pylori vaccine |
| 3 | Experimental | Not described Receives: Biological: helicobacter pylori vaccine |
| 4 | Experimental | Not described Receives: Biological: helicobacter pylori vaccine |
| 5 | Placebo comparator | Not described Receives: Biological: Placebo |
| 6 | Experimental | Not described Receives: Biological: helicobacter pylori vaccine |
| 7 | Experimental | Not described Receives: Biological: helicobacter pylori vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures: injection site and systemic reactions
Measured: 5 months
Secondary outcomes (1)
Immunogencity measures: antigen-specific antibodies and cellular immune response
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startFeb 2001
- Primary completionDec 2001
- Study completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613665
- Sponsor's protocol ID
- HPP002
- Status last verified
- Jun 2013
- First submitted
- 31 Jan 2008
- Last updated
- 11 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomized, Controlled, Single-blind, Dose-Ranging and Schedule-Finding Study of the Safety, Tolerability, and Immunogenicity of Chiron Helicobacter Pylori Vaccine in Healthy, Helicobacter Pylori-negative Adults
- ClinicalTrials.gov ID
- NCT00613665
- Acronym / sponsor ID
- HPP002
- Conditions
- Helicobacter Pylori, Gastritis, Gastric Cancer, Gastroduodenal Ulcers, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Dec 2001 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: helicobacter pylori vaccine |
| 2 | Experimental | Biological: helicobacter pylori vaccine |
| 3 | Experimental | Biological: helicobacter pylori vaccine |
| 4 | Experimental | Biological: helicobacter pylori vaccine |
| 5 | Placebo comparator | Biological: Placebo |
| 6 | Experimental | Biological: helicobacter pylori vaccine |
| 7 | Experimental | Biological: helicobacter pylori vaccine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Ages 18-40
- Negative for H. pylori infection
- Contraception for females
Key exclusion criteria (5 listed)
- Present or past H. pylori infection
- Medically significant gastroduodenal disease
- Recent corticosteroid use
- Bleed diathesis
- Use of antibiotics used to treat H. pylori infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| helicobacter pylori vaccineExperimental 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 | Biological | 1 |
| helicobacter pylori vaccineSeven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly | Biological | 2 |
| helicobacter pylori vaccineSeven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly | Biological | 3 |
| helicobacter pylori vaccineEight subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly | Biological | 4 |
| PlaceboNine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly | Biological | 5 |
| helicobacter pylori vaccineNine subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly | Biological | 6 |
| helicobacter pylori vaccineTen subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly | Biological | 7 |
Primary outcome
Safety measures: injection site and systemic reactions
Time frame: 5 months
1 secondary outcome
Immunogencity measures: antigen-specific antibodies and cellular immune response
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Vaccines study chair
Novartis Vaccines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing helicobacter pylori vaccine in people with Helicobacter Pylori and Gastritis, run by Novartis Vaccines at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measures: injection site and systemic reactions (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2013.