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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003511-31 |
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To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H.pylori vaccines | Biological | 1 dose of H.pylori vaccine at 0, 1, and 2 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo. | The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo). Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT). | 12 weeks post HP challenge |
| Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination | To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local* and systemic adverse events. | Day 1-7 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups | The time course of HP infection following HP challenge in subjects of the HP vaccine and placebo groups, were assessed by non-invasive HP tests. | 12 months |
| The Geometric Mean Concentrations After HP Vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otto von Guericke Universität Magdeburg | Magdeburg | 39120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30042064 | Derived | Malfertheiner P, Selgrad M, Wex T, Romi B, Borgogni E, Spensieri F, Zedda L, Ruggiero P, Pancotto L, Censini S, Palla E, Kanesa-Thasan N, Scharschmidt B, Rappuoli R, Graham DY, Schiavetti F, Del Giudice G. Efficacy, immunogenicity, and safety of a parenteral vaccine against Helicobacter pylori in healthy volunteers challenged with a Cag-positive strain: a randomised, placebo-controlled phase 1/2 study. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):698-707. doi: 10.1016/S2468-1253(18)30125-0. Epub 2018 Jul 2. | |
| 29066327 |
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All subjects enrolled were included in the trial.
Subjects were recruited from a single study center in Germany
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (HP Vaccine) | Subjects received three injections of HP Vaccine at 0, 1, and 2 months, followed by H.pylori challenge(oral administration of infectious HP inoculum)1 month later. |
| FG001 | Group II (Placebo) | Subjects received three injections of Placebo at 0, 1, and 2 months,followed by H.pylori challenge (oral administration of infectious HP inoculum)1 month later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (HP Vaccine) | Subjects received three injections of HP Vaccine at 0, 1, and 2 months. |
| BG001 | Group II (Placebo) | Subjects received three injections of Placebo at 0, 1, and 2 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo. | The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo). Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT). | Per-protocol dataset | Posted | Number | Percentage of subjects | 12 weeks post HP challenge |
|
Throughout the study period (12-14 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (HP Vaccine) | Subjects received three injections of HP Vaccine at 0, 1, and 2 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pilonidal cyst | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
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| Placebo Vaccine |
| Biological |
Placebo Vaccine at 0, 1, and 2 months |
|
The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP)after HP vaccination as compared to placebo are reported. |
| upto 1 month after 3rd vaccination |
| Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge. | The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP) after HP challenge were compared between vaccinated and placebo groups. | 12 months |
| Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge | The response to 3 doses of HP vaccine and the oral HP challenge was assessed with respect their ability to induce differentiation and changes in the phenotype of a subset of regulatory T-cells CD4+CD25+Foxp3+ that expresses Treg Markers PD-1 and/or HLA-DR. | 12 weeks post HP challenge |
| Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI) | The proliferation of H. pylori-specific Peripheral blood mononuclear cells (PBMCs) following HP antigen stimulation was assessed to measure the magnitude of the cell mediated immune response. | 12 weeks post HP challenge |
| Derived |
| Nell S, Estibariz I, Krebes J, Bunk B, Graham DY, Overmann J, Song Y, Sproer C, Yang I, Wex T, Korlach J, Malfertheiner P, Suerbaum S. Genome and Methylome Variation in Helicobacter pylori With a cag Pathogenicity Island During Early Stages of Human Infection. Gastroenterology. 2018 Feb;154(3):612-623.e7. doi: 10.1053/j.gastro.2017.10.014. Epub 2017 Oct 21. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| OG001 | Group II (Placebo) | Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later. |
|
|
| Primary | Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination | To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local* and systemic adverse events. | This analysis was done on the safety dataset | Posted | Number | Participants | Day 1-7 post vaccination |
|
|
|
| Secondary | The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups | The time course of HP infection following HP challenge in subjects of the HP vaccine and placebo groups, were assessed by non-invasive HP tests. | Posted | Number | Participants | 12 months |
|
|
|
| Secondary | The Geometric Mean Concentrations After HP Vaccination. | The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP)after HP vaccination as compared to placebo are reported. | Per-Protocol dataset | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | upto 1 month after 3rd vaccination |
|
|
|
| Secondary | Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge. | The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP) after HP challenge were compared between vaccinated and placebo groups. | Per-protocol dataset | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 12 months |
|
|
|
| Secondary | Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge | The response to 3 doses of HP vaccine and the oral HP challenge was assessed with respect their ability to induce differentiation and changes in the phenotype of a subset of regulatory T-cells CD4+CD25+Foxp3+ that expresses Treg Markers PD-1 and/or HLA-DR. | Per-protocol dataset | Posted | Mean | Standard Deviation | percentage of T-cells | 12 weeks post HP challenge |
|
|
|
| Secondary | Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI) | The proliferation of H. pylori-specific Peripheral blood mononuclear cells (PBMCs) following HP antigen stimulation was assessed to measure the magnitude of the cell mediated immune response. | Per-protocol dataset | Posted | Mean | Standard Deviation | Stimulation Index (SI) | 12 weeks post HP challenge |
|
|
|
| 1 |
| 36 |
| 33 |
| 36 |
| EG001 | Group II (Placebo) | Subjects received three injections of Placebo at 0, 1, and 2 months | 0 | 27 | 25 | 27 |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA | Systematic Assessment |
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| Injection site warmth | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
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| Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
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| Injection site induration* |
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| Injection site swelling* |
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| Injection site warmth* |
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| Injection site tenderness* |
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| Injection site pain* |
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| Any Systemic |
|
| Chills |
|
| Malaise |
|
| Myalgia |
|
| Arthralgia |
|
| Headache |
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| Fatigue |
|
| Rash |
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| Fever (≥38C) |
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| Any Other# |
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| Analgesic antipyretic medication used# |
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| Stayed at home due to reaction# |
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| 1 week post challenge (UBT positive) |
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| 2 weeks post challenge (UBT positive) |
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| 3 weeks post challenge (UBT positive) |
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| 4 weeks post challenge (UBT positive) |
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| 8 weeks post challenge (UBT positive) |
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| 12 weeks post challenge (UBT positive) |
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| Post eradication (UBT positive) (N=7,7) |
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| Baseline (FAT positive) |
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| 1 week post challenge (FAT positive) |
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| 2 weeks post challenge (FAT positive) |
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| 3 weeks post challenge (FAT positive) |
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| 4 weeks post challenge (FAT positive) |
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| 8 weeks post challenge (FAT positive) |
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| 12 weeks post challenge (FAT positive) |
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| Post eradication (FAT positive) (N=7,7) |
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| 2 months after 1st vaccination (CagA antigen) |
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| 3 months after 1st vaccination (CagA antigen) |
|
| Baseline (NAP antigen) |
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| 1 month after 1st vaccination (NAP antigen) |
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| 2 months after 1st vaccination (NAP antigen) |
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| 3 months after 1st vaccination (NAP antigen) |
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| Baseline (VacA antigen) |
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| 1 month after 1st vaccination (VacA antigen) |
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| 2 months after 1st vaccination (VacA antigen) |
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| 3 months after 1st vaccination (VacA antigen) |
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| 1 month after 1st vaccination(CagA ) |
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| 2 months after 1st vaccination (CagA ) |
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| 3 months after 1st vaccination (CagA ) |
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| 2 weeks post HP challenge (CagA) |
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| 4 weeks post HP challenge (CagA) |
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| 12 weeks post HP challenge (CagA) |
|
| Baseline (NAP) |
|
| 1 month after 1st vaccination (NAP) |
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| 2 month after 1st vaccination (NAP) |
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| 3 month after 1st vaccination (NAP) |
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| 2 weeks post HP challenge (NAP) |
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| 4 weeks post HP challenge (NAP) |
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| 12 weeks post HP challenge (NAP) |
|
| Baseline (VacA) |
|
| 1 month after 1st vaccination (VacA) |
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| 2 months after 1st vaccination (VacA) |
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| 3 months after 1st vaccination (VacA) |
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| 2 weeks post HP challenge (VacA) |
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| 4 weeks post HP challenge (VacA) |
|
| 12 weeks post HP challenge (VacA) |
|
| 2 weeks post challenge (FOXP3+) (N=15,14) |
|
| 12 weeks post challenge (FOXP3+)(N=10,9) |
|
| Screening (HLADR TOT) |
|
| HP challenge (HLADR TOT) (N=18,15) |
|
| 2 weeks post challenge (HLADR TOT) (N=15,14) |
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| 12 weeks post challenge (HLADR TOT) (N=10,9) |
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| Screening (PD-1 TOT) |
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| HP challenge (PD-1 TOT) (N=18,15) |
|
| 2 weeks post challenge (PD-1 TOT) (N=15,14) |
|
| 12 weeks post challenge (PD-1 TOT) (N=10,9) |
|
| 2 weeks post challenge (N=17,13) |
|
| 12 weeks post challenge (N=13,12) |
|