Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 37 for:    "Shigellosis"

Safety and Efficacy Study of WRSS1, a Shigella Sonnei Vaccine Candidate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01080716
Recruitment Status : Completed
First Posted : March 4, 2010
Results First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Collaborators:
Mahidol University
National Institutes of Health (NIH)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Dysentery
Shigella
Diarrhea
Interventions Biological: Part 1/Arm 1 of Study: WRSS1 vaccine
Biological: Part 1/Arm 2 of Study: Placebo vaccine
Biological: Part 2/Arm 1 of Study: S. sonnei 53G
Biological: Part 2/Arm 2 of Study: S. sonnei 53G
Enrollment 30
Recruitment Details Volunteers were recruited by contacting people from a list of potential volunteers from previous studies, by friend to friend contact, by internal announcement or by presentation booth in the university, community or blood donor sites. Recruitment and screening was performed by the staff at the Vaccine Trial Center, Mahidol University.
Pre-assignment Details Part 1 - total of 20 volunteers (14 vaccinees and 6 controls) Part 2 - was started approximately 60 days after WRSS1 vaccination. 10 vaccinees from part 1 and 10 naïve controls
Arm/Group Title Arm 1: WRSS1 Vaccine Arm 1: Placebo Vaccine Arm 2: S. Sonnei 53G Arm 2: S. Sonnei 53G (Naive Subjects)
Hide Arm/Group Description WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S. sonnei Placebo comparator 10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given S. sonnei 53G 10 naïve controls given S. sonnei 53G
Period Title: Part 1
Started 14 6 0 0
Completed 13 6 0 0
Not Completed 1 0 0 0
Reason Not Completed
Physician Decision             1             0             0             0
Period Title: Part 2
Started 0 0 10 10
Completed 0 0 10 10
Not Completed 0 0 0 0
Arm/Group Title Part 1/Arm 1 of Study: WRSS1 Vaccine Part 1/Arm 2 of Study: Placebo Vaccine Part 2/Arm 1 of Study: S. Sonnei 53G Part 2/Arm 2 of Study: S Sonnei 53G (Controls) Total
Hide Arm/Group Description

WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei

Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1

Placebo comparator 10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei 10 subjects (naïve controls) given S. sonnei 53G Total of all reporting groups
Overall Number of Baseline Participants 13 6 10 10 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 6 participants 10 participants 10 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
6
 100.0%
10
 100.0%
10
 100.0%
39
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 6 participants 10 participants 10 participants 39 participants
Female
8
  61.5%
3
  50.0%
5
  50.0%
2
  20.0%
18
  46.2%
Male
5
  38.5%
3
  50.0%
5
  50.0%
8
  80.0%
21
  53.8%
[1]
Measure Analysis Population Description: 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 13 participants 6 participants 10 participants 10 participants 39 participants
13 6 10 10 39
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Overview of AEs highlighting all AEs, withdrawals and deaths related to AEs
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1/Arm 1 of Study: WRSS1 Vaccine Part 1/Arm 2 of Study: Placebo Vaccine Part 2/Arm 1 of Study: S. Sonnei 53G Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
Hide Arm/Group Description:

WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei

Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1

Placebo comparator
10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
10 subjects (naïve controls) given S. sonnei 53G
Overall Number of Participants Analyzed 13 6 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
All Adverse Events
9
  69.2%
5
  83.3%
8
  80.0%
10
 100.0%
All Serious Adverse Events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Withdrawals Due to Adverse Events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Deaths
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Shigella Induced Clinical Disease in Part 2
Hide Description Study Part 2-Frequency of Shigella induced clinical disease defined as one or more of diarrhea, dysentery or fever in vaccinees and controls following challenge with S. sonnei 53G. Transmissibility of disease will be evaluated by the presence of fecal shedding in control subjects.
Time Frame 0-5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants in vaccine and controls following the challenge who experienced one or more clinical disease criteria
Arm/Group Title Part 2/Arm 1 of Study: S. Sonnei 53G Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
Hide Arm/Group Description:
10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
10 subjects (naïve controls) given S. sonnei 53G
Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
Diarrhea Yes
1
  10.0%
1
  10.0%
No
9
  90.0%
9
  90.0%
Dysentery Yes
2
  20.0%
2
  20.0%
No
8
  80.0%
8
  80.0%
Fever Yes
1
  10.0%
2
  20.0%
No
9
  90.0%
8
  80.0%
Abdominal Pain Yes
1
  10.0%
2
  20.0%
No
9
  90.0%
8
  80.0%
Tenesmus Yes
1
  10.0%
2
  20.0%
No
9
  90.0%
8
  80.0%
Nausea Yes
1
  10.0%
1
  10.0%
No
9
  90.0%
9
  90.0%
Vomiting Yes
0
   0.0%
1
  10.0%
No
10
 100.0%
9
  90.0%
Myalgia Yes
2
  20.0%
2
  20.0%
No
8
  80.0%
8
  80.0%
Joint Pain Yes
0
   0.0%
0
   0.0%
No
10
 100.0%
10
 100.0%
Dizziness Yes
2
  20.0%
2
  20.0%
No
8
  80.0%
8
  80.0%
Anorexia Yes
1
  10.0%
1
  10.0%
No
9
  90.0%
9
  90.0%
Malaise Yes
3
  30.0%
2
  20.0%
No
7
  70.0%
8
  80.0%
Headache Yes
2
  20.0%
1
  10.0%
No
8
  80.0%
9
  90.0%
Meet Criteria of Clinical Disease Yes
3
  30.0%
3
  30.0%
No
7
  70.0%
7
  70.0%
Meet Criteria by External Review Yes
3
  30.0%
6
  60.0%
No
7
  70.0%
4
  40.0%
Shedding S.sonnei (Fecal) Yes
6
  60.0%
7
  70.0%
No
4
  40.0%
3
  30.0%
3.Secondary Outcome
Title Count of Subjects With Normal and Abnormal Clinical Laboratory Values During Parts 1 and 2 of Study
Hide Description Count of subjects in Parts 1 and 2 with normal and abnormal clinical laboratory values after samples taken on days 1, 7, 14, and 28. Abnormal lab values are determined clinically significant by the PI
Time Frame Days 1, 7, 14, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Count of subjects in Parts 1 and 2 with normal and abnormal clinical laboratory values after samples taken on days 1, 7, 14, and 28. Abnormal lab values are determined clinically significant by the PI. Results were not presented per arm in the FCSR, but were instead presented as parts 1 and 2 of the study.
Arm/Group Title Subjects From Part 1 of Study Subjects From Part 2 of Study
Hide Arm/Group Description:
Analysis of abnormal clinical laboratory values in subjects from Part 1 of study
Analysis of abnormal clinical laboratory values in subjects from Part 2 of study
Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
Not Clinically Abnormal
20
 100.0%
19
  95.0%
Clinically Abnormal
0
   0.0%
1
   5.0%
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part 1/Arm 1 of Study: WRSS1 Vaccine Part 1/Arm 2: Placebo Part 2/Arm 1 of Study: S. Sonnei 53G Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
Hide Arm/Group Description

WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei

Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1

Placebo comparator 10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei 10 subjects (naïve controls) given S. sonnei 53G
All-Cause Mortality
Part 1/Arm 1 of Study: WRSS1 Vaccine Part 1/Arm 2: Placebo Part 2/Arm 1 of Study: S. Sonnei 53G Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part 1/Arm 1 of Study: WRSS1 Vaccine Part 1/Arm 2: Placebo Part 2/Arm 1 of Study: S. Sonnei 53G Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/6 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part 1/Arm 1 of Study: WRSS1 Vaccine Part 1/Arm 2: Placebo Part 2/Arm 1 of Study: S. Sonnei 53G Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/13 (69.23%)      5/6 (83.33%)      8/10 (80.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders         
Eosinophilia  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal disorders         
Diarrheic stool  1 [1]  2/13 (15.38%)  2 4/6 (66.67%)  4 4/10 (40.00%)  4 2/10 (20.00%)  2
Water stool  1 [1]  2/13 (15.38%)  2 1/6 (16.67%)  1 1/10 (10.00%)  1 6/10 (60.00%)  6
Abdominal pain  1 [1]  1/13 (7.69%)  1 2/6 (33.33%)  2 0/10 (0.00%)  0 1/10 (10.00%)  1
Nausea  1 [1]  1/13 (7.69%)  1 0/6 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1
Lower abdominal pain  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Abdominal pain (epigastrium)  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Abdominal pain (generalized)  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Dysentery  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 3/10 (30.00%)  3 1/10 (10.00%)  1
Abdominal pain (whole)  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1
Diarrhea  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Abdominal discomfort  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Aphthous  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Vomiting  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Increased bowel sound  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Perianal abscess  1 [2]  0/13 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
General disorders         
Feverish  1 [1]  3/13 (23.08%)  3 0/6 (0.00%)  0 2/10 (20.00%)  2 3/10 (30.00%)  3
Malaise  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 3/10 (30.00%)  3 2/10 (20.00%)  2
Fatigue  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 3/10 (30.00%)  3 1/10 (10.00%)  1
Immune system disorders         
Urticaria  1 [1]  1/13 (7.69%)  1 0/6 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Infections and infestations         
Conjunctivitis  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Herpes (lip)  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Shigellosis  1 [3]  0/13 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Injury, poisoning and procedural complications         
Abrasion wound at peri-anal  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Tendinitis  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Investigations         
High ALT  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Metabolism and nutrition disorders         
Anorexia  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 2/10 (20.00%)  2 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders         
Tenderness at digit of left foot  1 [2]  1/13 (7.69%)  1 0/6 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Myalgia  1 [1]  1/13 (7.69%)  1 0/6 (0.00%)  0 1/10 (10.00%)  1 5/10 (50.00%)  5
Myalgia at back  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Tenesmus  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 1/10 (10.00%)  1 2/10 (20.00%)  2
Myalgia at neck  1 [2]  0/13 (0.00%)  0 0/6 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Myalgia  1 [2]  0/13 (0.00%)  0 0/6 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Chills  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0
Myalgia at right shoulder  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Nervous system disorders         
Headache  1 [1]  8/13 (61.54%)  8 2/6 (33.33%)  2 4/10 (40.00%)  4 2/10 (20.00%)  2
Dizziness  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 4/10 (40.00%)  4 4/10 (40.00%)  4
Psychiatric disorders         
Insomnia (sleep difficulty)  1 [1]  1/13 (7.69%)  1 0/6 (0.00%)  0 2/10 (20.00%)  2 1/10 (10.00%)  1
Reproductive system and breast disorders         
Dysmenorrhea  1 [1]  0/13 (0.00%)  0 2/6 (33.33%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pharyngitis  1 [2]  0/13 (0.00%)  0 1/6 (16.67%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Common cold  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 2/10 (20.00%)  2 3/10 (30.00%)  3
Nasal swelling  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis  1 [1]  1/13 (7.69%)  1 0/6 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Pruritus at left thigh  1 [1]  0/13 (0.00%)  0 1/6 (16.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Pruritus  1 [1]  0/13 (0.00%)  0 0/6 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Mild
[2]
Moderate
[3]
Severe
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Punnee Pitisutithum, MBBS, DTM&H, FRCPT
Organization: Vaccine Trial Treatment Center, Mahidol University
Phone: 66-2-643-5599
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01080716     History of Changes
Other Study ID Numbers: A-15647
09-0021 ( Other Identifier: NIH/DMID )
1609 ( Other Identifier: WRAIR IRB )
First Submitted: December 23, 2009
First Posted: March 4, 2010
Results First Submitted: December 13, 2016
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018