Trial Outcomes & Findings for Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a (NCT NCT02646371)
NCT ID: NCT02646371
Last Updated: 2021-01-27
Results Overview
The attack rate of shigellosis after challenge in vaccine group versus in placebo group was analyzed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Between Day 56 and Day 64
Results posted on
2021-01-27
Participant Flow
Participant milestones
| Measure |
Flexyn2a - Vaccination
2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart
Flexyn2a: 2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart
|
Placebo - Vaccination
2 doses of TBS solution will be injected intramuscularly 4 weeks apart
Placebo: 2 doses of TBS solution will be injected intramuscularly 4 weeks apart
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
Baseline characteristics by cohort
| Measure |
Flexyn2a - Vaccination
n=34 Participants
2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart
Flexyn2a: 2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart
|
Placebo - Vaccination
n=33 Participants
2 doses of TBS solution will be injected intramuscularly 4 weeks apart
Placebo: 2 doses of TBS solution will be injected intramuscularly 4 weeks apart
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.6 years
n=5 Participants
|
34.4 years
n=7 Participants
|
35.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between Day 56 and Day 64The attack rate of shigellosis after challenge in vaccine group versus in placebo group was analyzed.
Outcome measures
| Measure |
Flexyn2a
n=30 Participants
The Flexyn2a treatment arm that was challenged.
|
Placebo
n=29 Participants
The control (Placebo) treatment arm that was challenged.
|
|---|---|---|
|
Attack Rate of Shigellosis in Vaccinated Subjects.
|
13 Participants
|
18 Participants
|
Adverse Events
Flexyn2a - Vaccination
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo - Vaccination
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 |
Flexyn2a - Vaccination
n=34 participants at risk
In the Flexyn2a treatment arm - 34 subjects received the first Flexyn2a vaccine and 34 subjects received the second Flexyn2a vaccine.
|
Placebo - Vaccination
n=33 participants at risk
In the control treatment (Placebo) arm - 34 subjects received the first Placebo vaccine and 30 subjects received the second Placebo vaccine.
|
|---|---|---|
|
Blood and lymphatic system disorders
Unsolicited (Blood and lymphatic)
|
20.6%
7/34
|
12.1%
4/33
|
|
Cardiac disorders
Unsolicited (Cardiac disorders)
|
2.9%
1/34
|
0.00%
0/33
|
|
Eye disorders
Unsolicited (Eye disorders)
|
2.9%
1/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Unsolicited (Gastrointestinal disorders)
|
5.9%
2/34
|
6.1%
2/33
|
|
General disorders
Unsolicited (General disorders and administration site conditions)
|
5.9%
2/34
|
3.0%
1/33
|
|
Infections and infestations
Unsolicited (Infections and infestations)
|
8.8%
3/34
|
9.1%
3/33
|
|
Injury, poisoning and procedural complications
Unsolicited (Injury, poisoning and procedural complications)
|
2.9%
1/34
|
3.0%
1/33
|
|
Investigations
Unsolicited (Investigations)
|
17.6%
6/34
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Unsolicited (Metabolism and nutrition disorders)
|
14.7%
5/34
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Unsolicited (Musculoskeletal and connective tissue disorders)
|
8.8%
3/34
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
Unsolicited (Respiratory, thoracic and mediastinal disorders)
|
5.9%
2/34
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
Unsolicited (Skin and subcutaneous tissue disorders)
|
5.9%
2/34
|
0.00%
0/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER