Trial Outcomes & Findings for Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701 (NCT NCT03576183)
NCT ID: NCT03576183
Last Updated: 2021-04-23
Results Overview
within 120 hours of challenge with ETEC strain LSN03-016011/A.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
5 days after challenge
Results posted on
2021-04-23
Participant Flow
Participant milestones
| Measure |
VLA1701
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
The vaccine is administered orally in 2 doses about 1 week apart.
VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Challenge Strain: LSN03-016011/A
|
Placebo
The buffer component of VLA1701 will be used as Placebo.
The vaccine is administered orally in 2 doses about 1 week apart.
Placebo: buffer component of VLA1701
Challenge Strain: LSN03-016011/A
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701
Baseline characteristics by cohort
| Measure |
VLA1701
n=15 Participants
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
The vaccine is administered orally in 2 doses about 1 week apart.
VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Challenge Strain: LSN03-016011/A
|
Placebo
n=15 Participants
The buffer component of VLA1701 will be used as Placebo.
The vaccine is administered orally in 2 doses about 1 week apart.
Placebo: buffer component of VLA1701
Challenge Strain: LSN03-016011/A
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 7.89 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 9.09 • n=7 Participants
|
35.1 years
STANDARD_DEVIATION 8.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other: Multi-racial
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other: Latino / Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 days after challengePopulation: Challenge Population = all subjects who received two doses of the vaccine and the challenge dose
within 120 hours of challenge with ETEC strain LSN03-016011/A.
Outcome measures
| Measure |
VLA1701
n=15 Participants
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
The vaccine is administered orally in 2 doses about 1 week apart.
VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Challenge Strain: LSN03-016011/A
|
Placebo
n=15 Participants
The buffer component of VLA1701 will be used as Placebo.
The vaccine is administered orally in 2 doses about 1 week apart.
Placebo: buffer component of VLA1701
Challenge Strain: LSN03-016011/A
|
|---|---|---|
|
Percentage of Subjects With Moderate to Severe Diarrhea
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 7 days after challengePopulation: Challenge Population = all subjects who received two doses of the vaccine and the challenge dose
ETEC diarrhea disease severity score with a score ranging from 0 (no disease) to 8 (most severe disease) utilizing objective signs, subjective Symptoms and stool output.
Outcome measures
| Measure |
VLA1701
n=15 Participants
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
The vaccine is administered orally in 2 doses about 1 week apart.
VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Challenge Strain: LSN03-016011/A
|
Placebo
n=15 Participants
The buffer component of VLA1701 will be used as Placebo.
The vaccine is administered orally in 2 doses about 1 week apart.
Placebo: buffer component of VLA1701
Challenge Strain: LSN03-016011/A
|
|---|---|---|
|
Disease Severity Score After Challenge With ETEC Strain LSN03-016011/ A
|
2.3 units on a scale
Standard Deviation 1.7
|
3.7 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 7days after each vaccinationPopulation: Safety Population = all subjects who entered into the study and received at least one vaccination
adverse events covered by the subjects memory card
Outcome measures
| Measure |
VLA1701
n=17 Participants
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
The vaccine is administered orally in 2 doses about 1 week apart.
VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Challenge Strain: LSN03-016011/A
|
Placebo
n=17 Participants
The buffer component of VLA1701 will be used as Placebo.
The vaccine is administered orally in 2 doses about 1 week apart.
Placebo: buffer component of VLA1701
Challenge Strain: LSN03-016011/A
|
|---|---|---|
|
Percentage of Subjects With Solicited Adverse Events
Dizziness
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Solicited Adverse Events
Fatique
|
0 percentage of participants
Interval 0.0 to 18.4
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
|
Percentage of Subjects With Solicited Adverse Events
Diarrhea
|
17.6 percentage of participants
Interval 6.2 to 41.0
|
11.8 percentage of participants
Interval 3.3 to 34.3
|
|
Percentage of Subjects With Solicited Adverse Events
Fever
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Solicited Adverse Events
Nausea
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Solicited Adverse Events
Bloating
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
11.8 percentage of participants
Interval 3.3 to 34.3
|
|
Percentage of Subjects With Solicited Adverse Events
Vomiting
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Solicited Adverse Events
Generalized Myalgia
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Solicited Adverse Events
Arthralgia
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Solicited Adverse Events
Abdominal Pain
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
|
Percentage of Subjects With Solicited Adverse Events
Abdominal Cramping
|
0 percentage of participants
Interval 0.0 to 18.4
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
|
Percentage of Subjects With Solicited Adverse Events
Malaise
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Solicited Adverse Events
Headache
|
17.6 percentage of participants
Interval 6.2 to 41.0
|
11.8 percentage of participants
Interval 3.3 to 34.3
|
|
Percentage of Subjects With Solicited Adverse Events
Loss of appetite
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Solicited Adverse Events
Urticaria
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Solicited Adverse Events
Chills
|
0 percentage of participants
Interval 0.0 to 18.4
|
11.8 percentage of participants
Interval 3.3 to 34.3
|
|
Percentage of Subjects With Solicited Adverse Events
Rash
|
0 percentage of participants
Interval 0.0 to 18.4
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
SECONDARY outcome
Timeframe: until Month 6Population: Safety Population = all subjects who entered into the study and received at least one vaccination
Outcome measures
| Measure |
VLA1701
n=17 Participants
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
The vaccine is administered orally in 2 doses about 1 week apart.
VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Challenge Strain: LSN03-016011/A
|
Placebo
n=17 Participants
The buffer component of VLA1701 will be used as Placebo.
The vaccine is administered orally in 2 doses about 1 week apart.
Placebo: buffer component of VLA1701
Challenge Strain: LSN03-016011/A
|
|---|---|---|
|
Percentage of Subjects With Any Adverse Events (AE)
any unsolicited AE - prior Challenge
|
17.6 percentage of participants
Interval 6.2 to 41.0
|
23.5 percentage of participants
Interval 9.6 to 47.3
|
|
Percentage of Subjects With Any Adverse Events (AE)
any unsolicited AE related - prior Challenge
|
11.8 percentage of participants
Interval 3.3 to 34.3
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
|
Percentage of Subjects With Any Adverse Events (AE)
any severe unsolicited AE - prior Challenge
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Any Adverse Events (AE)
any unsolicited AE lead vacc. withdrawn - prior
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Any Adverse Events (AE)
any unsolicite AE leading discontinuation - prior
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
|
Percentage of Subjects With Any Adverse Events (AE)
any unsolicited AE - entiry study period
|
58.8 percentage of participants
Interval 36.0 to 78.4
|
76.5 percentage of participants
Interval 52.7 to 90.4
|
|
Percentage of Subjects With Any Adverse Events (AE)
any unsolicited AE related - entire study period
|
11.8 percentage of participants
Interval 3.3 to 34.3
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
|
Percentage of Subjects With Any Adverse Events (AE)
any severe unsolicited AE - entire study period
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
23.5 percentage of participants
Interval 9.6 to 47.3
|
|
Percentage of Subjects With Any Adverse Events (AE)
any unsolicited AE leading discontinuation - study
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
SECONDARY outcome
Timeframe: until Month 6Population: Safety Population = all subjects who entered into the study and received at least one vaccination
Outcome measures
| Measure |
VLA1701
n=17 Participants
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
The vaccine is administered orally in 2 doses about 1 week apart.
VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Challenge Strain: LSN03-016011/A
|
Placebo
n=17 Participants
The buffer component of VLA1701 will be used as Placebo.
The vaccine is administered orally in 2 doses about 1 week apart.
Placebo: buffer component of VLA1701
Challenge Strain: LSN03-016011/A
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events
prior Challenge
|
0 participants
|
0 participants
|
|
Number of Subjects With Serious Adverse Events
entire study period
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to Visit 4 (day of challenge, 23 days post first vaccination)Population: Safety Population = all subjects who entered into the study and received at least one vaccination
unsolicited events
Outcome measures
| Measure |
VLA1701
n=17 Participants
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
The vaccine is administered orally in 2 doses about 1 week apart.
VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Challenge Strain: LSN03-016011/A
|
Placebo
n=17 Participants
The buffer component of VLA1701 will be used as Placebo.
The vaccine is administered orally in 2 doses about 1 week apart.
Placebo: buffer component of VLA1701
Challenge Strain: LSN03-016011/A
|
|---|---|---|
|
Percentage of Subjects With Any IMP (Investigational Medicinal Product) Related Adverse Events
|
11.8 percentage of participants
Interval 3.3 to 34.3
|
5.9 percentage of participants
Interval 1.0 to 27.0
|
SECONDARY outcome
Timeframe: up to Visit 4 (day of challenge, 23 days post first vaccination)Population: Safety Population = all subjects who entered into the study and received at least one vaccination
Outcome measures
| Measure |
VLA1701
n=17 Participants
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
The vaccine is administered orally in 2 doses about 1 week apart.
VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Challenge Strain: LSN03-016011/A
|
Placebo
n=17 Participants
The buffer component of VLA1701 will be used as Placebo.
The vaccine is administered orally in 2 doses about 1 week apart.
Placebo: buffer component of VLA1701
Challenge Strain: LSN03-016011/A
|
|---|---|---|
|
Percentage of Subjects With IMP-related Serious Adverse Events
|
0 percentage of participants
Interval 0.0 to 18.4
|
0 percentage of participants
Interval 0.0 to 18.4
|
Adverse Events
VLA1701
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VLA1701
n=17 participants at risk
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
The vaccine is administered orally in 2 doses about 1 week apart.
VLA1701: VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Challenge Strain: LSN03-016011/A
|
Placebo
n=17 participants at risk
The buffer component of VLA1701 will be used as Placebo.
The vaccine is administered orally in 2 doses about 1 week apart.
Placebo: buffer component of VLA1701
Challenge Strain: LSN03-016011/A
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
29.4%
5/17 • Number of events 6 • until Month 6
solicited and unsolicited AEs
|
47.1%
8/17 • Number of events 8 • until Month 6
solicited and unsolicited AEs
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
17.6%
3/17 • Number of events 3 • until Month 6
solicited and unsolicited AEs
|
35.3%
6/17 • Number of events 7 • until Month 6
solicited and unsolicited AEs
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Number of events 2 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Investigations
Alanine aminotransferase increased
|
17.6%
3/17 • Number of events 3 • until Month 6
solicited and unsolicited AEs
|
17.6%
3/17 • Number of events 3 • until Month 6
solicited and unsolicited AEs
|
|
Investigations
Culture stool positive
|
17.6%
3/17 • Number of events 3 • until Month 6
solicited and unsolicited AEs
|
11.8%
2/17 • Number of events 2 • until Month 6
solicited and unsolicited AEs
|
|
Investigations
Blood Creatinine increased
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Investigations
Haemoglobin decreased
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
General disorders
Fatigue
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
11.8%
2/17 • Number of events 2 • until Month 6
solicited and unsolicited AEs
|
|
General disorders
Suprapubic pain
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
General disorders
Thirst
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Infections and infestations
Oral herpes
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Vascular disorders
Hot flush
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Cardiac disorders
Bradycardia
|
5.9%
1/17 • Number of events 2 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.9%
1/17 • Number of events 2 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Ear and labyrinth disorders
Cerumen impaction
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Nervous system disorders
Presyncope
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/17 • until Month 6
solicited and unsolicited AEs
|
5.9%
1/17 • Number of events 1 • until Month 6
solicited and unsolicited AEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER