Phase I/II, Randomized, Observer-blind, Placebo-controlled, Single-Center Study of the Tolerability, Immunogenicity and Efficacy (following Helicobacter pylori infectious challenge) of Novartis’ Investigational H. pylori Vaccine in H. pylori-Negative Adults
- Conditions
- no medical condition: healthy subjects
- Registration Number
- EUCTR2007-003511-31-DE
- Lead Sponsor
- ovartis Vaccines and Diagnostics GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:
Individuals eligible to be enrolled into this study are those:
1. who are 18 to 40 years of age and in good health as determined by the outcome of a medical history, physical examination and clinical judgment of the investigator
2. able to comprehend and follow all required study procedures
3. willing and able to sign an informed consent form
4. who are determined not to be HP infected based on the results of non-invasive testing (i.e. HP serological test, UBT, fecal antigen) and UGE
5. who have a negative urine pregnancy test and use of hormonal or barrier method of birth control (females of childbearing age) throughout the 12-month duration of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria:
Individuals not eligible to be enrolled into this study are those who:
1. have household contact with children of age 2 or younger
2. have remote or current HP infection (as determined by HP serology, non-invasive HP testing, or by UGE)
3. have had major gastrointestinal surgery (e.g., other than appendectomy), documented peptic ulcer disease, gastrointestinal hemorrhage, gall bladder disease, inflammatory bowel disease, frequent diarrhea, or irritable bowel syndrome
4. have significant esophageal, gastric or duodenal pathology (gastric atrophy, dysplasia, or intestinal metaplasia ulcer or other abnormalities of the upper gastrointestinal tract) as determined by medical evaluation or UGE
5. have drug or alcohol dependence based on investigator clinical judgment
6. have significant acute or chronic medical or psychiatric illness
7. have any serious chronic or progressive disease (e.g., any history of neoplasm, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, signs of cardiac or renal failure or severe malnutrition)
8. have a known or suspected disease of the immune system, or are receiving immunosuppressive therapy, including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 60 days
9. regular use of salicylates, nonsteroidal anti-inflammatory drugs, anticoagulants, or gold salts
10. have allergy or intolerance to aspirin, other salicylates, lidocaine, lansoprazole, omeprazole, H2-receptor antagonists, bismuth, metronidazole, tetracycline, penicillin, amoxicillin, or macrolide antibiotics or use of any of these agents within 4 weeks prior to study entry
11. have taken antibiotics within 7 days prior to enrollment or medical condition requiring the use of antibiotics during the course of the study
12. have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
13. use of medications that may interact with bismuth, lansoprazole, omeprazole, amoxicillin, metronidazole, tetracycline, or macrolide antibiotics
14. have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study
15. are pregnant or nursing mothers
16. have any other serious chronic disease including progressive neurological disease or seizure disorder
17. have received blood, blood products or a parenteral immunoglobulin preparation within the previous 60 days
18. have a history of severe allergic reactions after previous vaccinations, such as anaphylactic shock, asthma, urticaria, or other serious allergic reaction or hypersensitivity to any vaccine component requiring medical intervention
19. have either received, or for whom there is intent to immunize with any other vaccine(s) within 30 days prior, through 30 days following, study injection; exception: licensed flu-vaccine should not be administered within 14 days prior to enrollment but may be administered while on study if medically appropriate
20. have any condition which in the opinion of the investigator and/or the medical monitor that may interfere with the evaluation of the study objectives
21. work for or under the direct and full-time supervision of the Coordinating Investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method