Trial Outcomes & Findings for Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults (NCT NCT00736476)
NCT ID: NCT00736476
Last Updated: 2017-02-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
12 weeks post HP challenge
Results posted on
2017-02-28
Participant Flow
Subjects were recruited from a single study center in Germany
All subjects enrolled were included in the trial.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
27
|
|
Overall Study
COMPLETED
|
35
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults
Baseline characteristics by cohort
| Measure |
Group I (HP Vaccine)
n=36 Participants
Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
|
Group II (Placebo)
n=27 Participants
Subjects received three injections of Placebo at 0, 1, and 2 months
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
24.0 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
26.1 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Gender
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Gender
Male
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post HP challengePopulation: Per-protocol dataset
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).
Outcome measures
| Measure |
Group I (HP Vaccine)
n=14 Participants
Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
|
Group II (Placebo)
n=13 Participants
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.
|
Group II (Placebo) Infected
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 after 3rd injection.
|
Group II (Placebo) Non-Infected
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 after 3rd injection.
|
|---|---|---|---|---|
|
The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.
UBT positive (non-invasive test)
|
0 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
|
The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.
FAT positive (non-invasive test)
|
21 Percentage of subjects
|
8 Percentage of subjects
|
—
|
—
|
|
The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.
HP culture positive (invasive test)
|
36 Percentage of subjects
|
46 Percentage of subjects
|
—
|
—
|
|
The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.
RUT positive (invasive test)
|
7 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
|
The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.
Histopathology positive (invasive test)
|
7 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
|
The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.
Positive HP infection (Invasive+non-invasive)
|
36 Percentage of subjects
|
46 Percentage of subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-7 post vaccinationPopulation: This analysis was done on the safety dataset
To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local\* and systemic adverse events.
Outcome measures
| Measure |
Group I (HP Vaccine)
n=36 Participants
Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
|
Group II (Placebo)
n=27 Participants
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.
|
Group II (Placebo) Infected
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 after 3rd injection.
|
Group II (Placebo) Non-Infected
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 after 3rd injection.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Any Local*
|
28 Participants
|
23 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Injection site erythema*
|
14 Participants
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Injection site induration*
|
8 Participants
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Injection site swelling*
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Injection site warmth*
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Injection site tenderness*
|
23 Participants
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Injection site pain*
|
24 Participants
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Any Systemic
|
26 Participants
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Chills
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Malaise
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Myalgia
|
17 Participants
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Arthralgia
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Headache
|
13 Participants
|
10 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Fatigue
|
13 Participants
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Rash
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Fever (≥38C)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Any Other#
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Analgesic antipyretic medication used#
|
9 Participants
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
Stayed at home due to reaction#
|
2 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsThe time course of HP infection following HP challenge in subjects of the HP vaccine and placebo groups, were assessed by non-invasive HP tests.
Outcome measures
| Measure |
Group I (HP Vaccine)
n=14 Participants
Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
|
Group II (Placebo)
n=13 Participants
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.
|
Group II (Placebo) Infected
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 after 3rd injection.
|
Group II (Placebo) Non-Infected
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 after 3rd injection.
|
|---|---|---|---|---|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
Baseline (UBT positive)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
HP challenge (≥3 months after vaccination)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
1 week post challenge (UBT positive)
|
4 Participants
|
1 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
2 weeks post challenge (UBT positive)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
3 weeks post challenge (UBT positive)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
4 weeks post challenge (UBT positive)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
8 weeks post challenge (UBT positive)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
12 weeks post challenge (UBT positive)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
Post eradication (UBT positive) (N=7,7)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
Baseline (FAT positive)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
1 week post challenge (FAT positive)
|
9 Participants
|
9 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
2 weeks post challenge (FAT positive)
|
8 Participants
|
9 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
3 weeks post challenge (FAT positive)
|
2 Participants
|
5 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
4 weeks post challenge (FAT positive)
|
3 Participants
|
4 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
8 weeks post challenge (FAT positive)
|
3 Participants
|
4 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
12 weeks post challenge (FAT positive)
|
3 Participants
|
1 Participants
|
—
|
—
|
|
The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
Post eradication (FAT positive) (N=7,7)
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: upto 1 month after 3rd vaccinationPopulation: Per-Protocol dataset
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.
Outcome measures
| Measure |
Group I (HP Vaccine)
n=35 Participants
Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
|
Group II (Placebo)
n=27 Participants
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.
|
Group II (Placebo) Infected
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 after 3rd injection.
|
Group II (Placebo) Non-Infected
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 after 3rd injection.
|
|---|---|---|---|---|
|
The Geometric Mean Concentrations After HP Vaccination.
Baseline (CagA antigen)
|
2.42 μg/mL
Interval 1.78 to 3.29
|
2.95 μg/mL
Interval 2.09 to 4.18
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
1 month after 1st vaccination (CagA antigen)
|
2.89 μg/mL
Interval 1.87 to 4.48
|
2.55 μg/mL
Interval 1.55 to 4.19
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
2 months after 1st vaccination (CagA antigen)
|
7.74 μg/mL
Interval 4.83 to 12.0
|
2.56 μg/mL
Interval 1.5 to 4.39
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
3 months after 1st vaccination (CagA antigen)
|
23 μg/mL
Interval 15.0 to 37.0
|
2.54 μg/mL
Interval 1.5 to 4.29
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
Baseline (NAP antigen)
|
4.59 μg/mL
Interval 3.95 to 5.33
|
5.84 μg/mL
Interval 4.92 to 6.93
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
1 month after 1st vaccination (NAP antigen)
|
35 μg/mL
Interval 25.0 to 50.0
|
5.47 μg/mL
Interval 3.68 to 8.13
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
2 months after 1st vaccination (NAP antigen)
|
236 μg/mL
Interval 175.0 to 319.0
|
5.15 μg/mL
Interval 3.66 to 7.24
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
3 months after 1st vaccination (NAP antigen)
|
148 μg/mL
Interval 111.0 to 197.0
|
2.54 μg/mL
Interval 1.5 to 4.29
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
Baseline (VacA antigen)
|
18 μg/mL
Interval 14.0 to 25.0
|
21 μg/mL
Interval 15.0 to 29.0
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
1 month after 1st vaccination (VacA antigen)
|
214 μg/mL
Interval 154.0 to 298.0
|
23 μg/mL
Interval 15.0 to 33.0
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
2 months after 1st vaccination (VacA antigen)
|
2468 μg/mL
Interval 1818.0 to 3350.0
|
23 μg/mL
Interval 15.0 to 33.0
|
—
|
—
|
|
The Geometric Mean Concentrations After HP Vaccination.
3 months after 1st vaccination (VacA antigen)
|
502 μg/mL
Interval 335.0 to 709.0
|
19 μg/mL
Interval 13.0 to 28.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Per-protocol dataset
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.
Outcome measures
| Measure |
Group I (HP Vaccine)
n=5 Participants
Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
|
Group II (Placebo)
n=9 Participants
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.
|
Group II (Placebo) Infected
n=6 Participants
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 after 3rd injection.
|
Group II (Placebo) Non-Infected
n=7 Participants
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 after 3rd injection.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
Baseline (CagA)
|
2.25 μg/mL
Interval 0.72 to 7.02
|
2.64 μg/mL
Interval 1.13 to 6.16
|
4.17 μg/mL
Interval 1.48 to 12.0
|
3.53 μg/mL
Interval 1.35 to 9.23
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
1 month after 1st vaccination(CagA )
|
2.24 μg/mL
Interval 0.42 to 12.0
|
4.54 μg/mL
Interval 1.31 to 16.0
|
3.84 μg/mL
Interval 0.83 to 18.0
|
3.06 μg/mL
Interval 0.74 to 13.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
2 months after 1st vaccination (CagA )
|
2.39 μg/mL
Interval 0.51 to 11.0
|
14 μg/mL
Interval 4.52 to 45.0
|
4.08 μg/mL
Interval 1.0 to 17.0
|
2.95 μg/mL
Interval 0.8 to 11.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
3 months after 1st vaccination (CagA )
|
13 μg/mL
Interval 3.29 to 48.0
|
93 μg/mL
Interval 34.0 to 250.0
|
3.84 μg/mL
Interval 1.13 to 13.0
|
2.63 μg/mL
Interval 0.85 to 8.12
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
2 weeks post HP challenge (CagA)
|
16 μg/mL
Interval 4.39 to 57.0
|
134 μg/mL
Interval 51.0 to 348.0
|
3.92 μg/mL
Interval 1.22 to 13.0
|
3.59 μg/mL
Interval 1.21 to 11.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
4 weeks post HP challenge (CagA)
|
30 μg/mL
Interval 8.89 to 102.0
|
261 μg/mL
Interval 105.0 to 648.0
|
4.11 μg/mL
Interval 1.35 to 13.0
|
3.39 μg/mL
Interval 1.21 to 9.5
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
12 weeks post HP challenge (CagA)
|
149 μg/mL
Interval 35.0 to 625.0
|
202 μg/mL
Interval 69.0 to 588.0
|
7.51 μg/mL
Interval 2.03 to 28.0
|
4.73 μg/mL
Interval 1.41 to 16.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
Baseline (NAP)
|
4.4 μg/mL
Interval 2.75 to 7.04
|
4.4 μg/mL
Interval 3.1 to 6.24
|
5.46 μg/mL
Interval 3.56 to 8.38
|
11 μg/mL
Interval 7.35 to 16.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
1 month after 1st vaccination (NAP)
|
19 μg/mL
Interval 10.0 to 36.0
|
62 μg/mL
Interval 39.0 to 99.0
|
5.46 μg/mL
Interval 3.11 to 9.59
|
8.48 μg/mL
Interval 5.03 to 14.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
2 month after 1st vaccination (NAP)
|
117 μg/mL
Interval 66.0 to 206.0
|
235 μg/mL
Interval 154.0 to 359.0
|
5.54 μg/mL
Interval 3.3 to 9.31
|
6.61 μg/mL
Interval 4.09 to 11.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
3 month after 1st vaccination (NAP)
|
101 μg/mL
Interval 60.0 to 172.0
|
251 μg/mL
Interval 170.0 to 373.0
|
5.35 μg/mL
Interval 3.3 to 8.66
|
6.59 μg/mL
Interval 4.22 to 10.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
2 weeks post HP challenge (NAP)
|
125 μg/mL
Interval 75.0 to 209.0
|
275 μg/mL
Interval 187.0 to 404.0
|
5.58 μg/mL
Interval 3.49 to 8.49
|
8.3 μg/mL
Interval 5.37 to 13.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
4 weeks post HP challenge (NAP)
|
179 μg/mL
Interval 105.0 to 305.0
|
325 μg/mL
Interval 219.0 to 484.0
|
4.4 μg/mL
Interval 2.7 to 7.16
|
8.32 μg/mL
Interval 5.3 to 13.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
12 weeks post HP challenge (NAP)
|
115 μg/mL
Interval 67.0 to 119.0
|
208 μg/mL
Interval 139.0 to 313.0
|
4.4 μg/mL
Interval 2.68 to 7.24
|
8.01 μg/mL
Interval 5.05 to 13.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
Baseline (VacA)
|
21 μg/mL
Interval 9.26 to 47.0
|
24 μg/mL
Interval 13.0 to 44.0
|
20 μg/mL
Interval 9.61 to 42.0
|
41 μg/mL
Interval 21.0 to 82.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
1 month after 1st vaccination (VacA)
|
117 μg/mL
Interval 46.0 to 295.0
|
285 μg/mL
Interval 143.0 to 569.0
|
16 μg/mL
Interval 6.89 to 37.0
|
33 μg/mL
Interval 16.0 to 70.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
2 months after 1st vaccination (VacA)
|
1219 μg/mL
Interval 501.0 to 2966.0
|
2754 μg/mL
Interval 1419.0 to 5344.0
|
25 μg/mL
Interval 11.0 to 56.0
|
33 μg/mL
Interval 16.0 to 70.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
3 months after 1st vaccination (VacA)
|
565 μg/mL
Interval 247.0 to 1292.0
|
979 μg/mL
Interval 529.0 to 1814.0
|
20 μg/mL
Interval 9.35 to 42.0
|
34 μg/mL
Interval 17.0 to 68.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
2 weeks post HP challenge (VacA)
|
606 μg/mL
Interval 252.0 to 1453.0
|
912 μg/mL
Interval 475.0 to 1751.0
|
24 μg/mL
Interval 11.0 to 53.0
|
45 μg/mL
Interval 22.0 to 94.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
4 weeks post HP challenge (VacA)
|
2174 μg/mL
Interval 995.0 to 4752.0
|
1943 μg/mL
Interval 1085.0 to 3479.0
|
28 μg/mL
Interval 14.0 to 57.0
|
46 μg/mL
Interval 22.0 to 94.0
|
|
Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
12 weeks post HP challenge (VacA)
|
3467 μg/mL
Interval 1632.0 to 7366.0
|
1469 μg/mL
Interval 838.0 to 2577.0
|
58 μg/mL
Interval 29.0 to 115.0
|
73 μg/mL
Interval 39.0 to 138.0
|
SECONDARY outcome
Timeframe: 12 weeks post HP challengePopulation: Per-protocol dataset
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.
Outcome measures
| Measure |
Group I (HP Vaccine)
n=19 Participants
Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
|
Group II (Placebo)
n=15 Participants
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.
|
Group II (Placebo) Infected
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 after 3rd injection.
|
Group II (Placebo) Non-Infected
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 after 3rd injection.
|
|---|---|---|---|---|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
Screening (FOXP3+)
|
1.12 percentage of T-cells
Standard Deviation 0.33
|
1.13 percentage of T-cells
Standard Deviation 0.56
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
HP challenge (FOXP3+) (N=18,15)
|
1.15 percentage of T-cells
Standard Deviation 0.43
|
1.07 percentage of T-cells
Standard Deviation 0.48
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
2 weeks post challenge (FOXP3+) (N=15,14)
|
1.34 percentage of T-cells
Standard Deviation 0.38
|
1.31 percentage of T-cells
Standard Deviation 0.57
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
12 weeks post challenge (FOXP3+)(N=10,9)
|
1.34 percentage of T-cells
Standard Deviation 0.45
|
0.87 percentage of T-cells
Standard Deviation 0.48
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
Screening (HLADR TOT)
|
24 percentage of T-cells
Standard Deviation 8.22
|
22 percentage of T-cells
Standard Deviation 10
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
HP challenge (HLADR TOT) (N=18,15)
|
23 percentage of T-cells
Standard Deviation 8.36
|
24 percentage of T-cells
Standard Deviation 11
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
2 weeks post challenge (HLADR TOT) (N=15,14)
|
23 percentage of T-cells
Standard Deviation 8.36
|
21 percentage of T-cells
Standard Deviation 8.44
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
12 weeks post challenge (HLADR TOT) (N=10,9)
|
21 percentage of T-cells
Standard Deviation 7.95
|
23 percentage of T-cells
Standard Deviation 11
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
Screening (PD-1 TOT)
|
5.8 percentage of T-cells
Standard Deviation 2.55
|
5.22 percentage of T-cells
Standard Deviation 2.06
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
HP challenge (PD-1 TOT) (N=18,15)
|
5.69 percentage of T-cells
Standard Deviation 1.93
|
5.4 percentage of T-cells
Standard Deviation 2.74
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
2 weeks post challenge (PD-1 TOT) (N=15,14)
|
6.12 percentage of T-cells
Standard Deviation 2.38
|
5.79 percentage of T-cells
Standard Deviation 2.52
|
—
|
—
|
|
Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
12 weeks post challenge (PD-1 TOT) (N=10,9)
|
4.33 percentage of T-cells
Standard Deviation 1.31
|
5.53 percentage of T-cells
Standard Deviation 2.11
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeks post HP challengePopulation: Per-protocol dataset
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.
Outcome measures
| Measure |
Group I (HP Vaccine)
n=20 Participants
Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
|
Group II (Placebo)
n=16 Participants
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.
|
Group II (Placebo) Infected
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 after 3rd injection.
|
Group II (Placebo) Non-Infected
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 after 3rd injection.
|
|---|---|---|---|---|
|
Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)
Screening
|
6.85 Stimulation Index (SI)
Standard Deviation 6.05
|
3.69 Stimulation Index (SI)
Standard Deviation 3.7
|
—
|
—
|
|
Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)
HP challenge (N=21,16)
|
26 Stimulation Index (SI)
Standard Deviation 21
|
3.81 Stimulation Index (SI)
Standard Deviation 2.61
|
—
|
—
|
|
Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)
2 weeks post challenge (N=17,13)
|
53 Stimulation Index (SI)
Standard Deviation 37
|
24 Stimulation Index (SI)
Standard Deviation 19
|
—
|
—
|
|
Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)
12 weeks post challenge (N=13,12)
|
28 Stimulation Index (SI)
Standard Deviation 23
|
7.83 Stimulation Index (SI)
Standard Deviation 2.82
|
—
|
—
|
Adverse Events
Group I (HP Vaccine)
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Group II (Placebo)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I (HP Vaccine)
n=36 participants at risk
Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
|
Group II (Placebo)
n=27 participants at risk
Subjects received three injections of Placebo at 0, 1, and 2 months
|
|---|---|---|
|
Infections and infestations
Pilonidal cyst
|
2.8%
1/36 • Number of events 1 • Throughout the study period (12-14 months)
|
0.00%
0/27 • Throughout the study period (12-14 months)
|
Other adverse events
| Measure |
Group I (HP Vaccine)
n=36 participants at risk
Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
|
Group II (Placebo)
n=27 participants at risk
Subjects received three injections of Placebo at 0, 1, and 2 months
|
|---|---|---|
|
General disorders
Chills
|
5.6%
2/36 • Number of events 2 • Throughout the study period (12-14 months)
|
0.00%
0/27 • Throughout the study period (12-14 months)
|
|
General disorders
Fatigue
|
36.1%
13/36 • Number of events 13 • Throughout the study period (12-14 months)
|
25.9%
7/27 • Number of events 7 • Throughout the study period (12-14 months)
|
|
General disorders
Influenza like illness
|
22.2%
8/36 • Number of events 8 • Throughout the study period (12-14 months)
|
0.00%
0/27 • Throughout the study period (12-14 months)
|
|
General disorders
Injection site erythema
|
38.9%
14/36 • Number of events 14 • Throughout the study period (12-14 months)
|
25.9%
7/27 • Number of events 7 • Throughout the study period (12-14 months)
|
|
General disorders
Injection site induration
|
22.2%
8/36 • Number of events 8 • Throughout the study period (12-14 months)
|
18.5%
5/27 • Number of events 5 • Throughout the study period (12-14 months)
|
|
General disorders
Injection site pain
|
77.8%
28/36 • Number of events 28 • Throughout the study period (12-14 months)
|
81.5%
22/27 • Number of events 22 • Throughout the study period (12-14 months)
|
|
General disorders
Injection site reaction
|
5.6%
2/36 • Number of events 2 • Throughout the study period (12-14 months)
|
0.00%
0/27 • Throughout the study period (12-14 months)
|
|
General disorders
Injection site swelling
|
13.9%
5/36 • Number of events 5 • Throughout the study period (12-14 months)
|
7.4%
2/27 • Number of events 2 • Throughout the study period (12-14 months)
|
|
General disorders
Injection site warmth
|
11.1%
4/36 • Number of events 4 • Throughout the study period (12-14 months)
|
11.1%
3/27 • Number of events 3 • Throughout the study period (12-14 months)
|
|
General disorders
Malaise
|
11.1%
4/36 • Number of events 4 • Throughout the study period (12-14 months)
|
11.1%
3/27 • Number of events 3 • Throughout the study period (12-14 months)
|
|
General disorders
Pain
|
5.6%
2/36 • Number of events 2 • Throughout the study period (12-14 months)
|
0.00%
0/27 • Throughout the study period (12-14 months)
|
|
Infections and infestations
Influenza
|
8.3%
3/36 • Number of events 3 • Throughout the study period (12-14 months)
|
11.1%
3/27 • Number of events 3 • Throughout the study period (12-14 months)
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
2/36 • Number of events 2 • Throughout the study period (12-14 months)
|
7.4%
2/27 • Number of events 2 • Throughout the study period (12-14 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
4/36 • Number of events 4 • Throughout the study period (12-14 months)
|
3.7%
1/27 • Number of events 1 • Throughout the study period (12-14 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
47.2%
17/36 • Number of events 17 • Throughout the study period (12-14 months)
|
40.7%
11/27 • Number of events 11 • Throughout the study period (12-14 months)
|
|
Nervous system disorders
Headache
|
38.9%
14/36 • Number of events 14 • Throughout the study period (12-14 months)
|
37.0%
10/27 • Number of events 10 • Throughout the study period (12-14 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
3/36 • Number of events 3 • Throughout the study period (12-14 months)
|
3.7%
1/27 • Number of events 1 • Throughout the study period (12-14 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
2/36 • Number of events 2 • Throughout the study period (12-14 months)
|
0.00%
0/27 • Throughout the study period (12-14 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60