Phase 1
N=63
Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults
Helicobacter Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT00736476 ↗Enrolled (actual)
63
Serious AEs
1.6%
Results posted
Feb 2017
Primary outcome: Primary: The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo. — 0; 0; 21; 8 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- H.pylori vaccines (Biological); Placebo Vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo. |
0; 0; 21; 8; 36; 46 | — |
| PRIMARY Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination |
28; 23; 14; 7; 8; 5 | — |
| SECONDARY The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups |
0; 0; 0; 0; 4; 1 | — |
| SECONDARY The Geometric Mean Concentrations After HP Vaccination. |
2.42; 2.95; 2.89; 2.55; 7.74; 2.56 | — |
| SECONDARY Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge. |
2.25; 2.64; 4.17; 3.53; 2.24; 4.54 | — |
| SECONDARY Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge |
1.12; 1.13; 1.15; 1.07; 1.34; 1.31 | — |
| SECONDARY Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI) |
6.85; 3.69; 26; 3.81; 53; 24 | — |
Summary
To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00736476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.