Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01080716
Other study ID # A-15647
Secondary ID 09-00211609
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2010
Est. completion date December 2011

Study information

Verified date October 2018
Source U.S. Army Medical Research and Materiel Command
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the WRSS1 candidate vaccine in healthy Thai adult volunteers.


Description:

This study is designed as 2 parts.

- Part 1 is a blinded, placebo-controlled inpatient trial in a total of 20 volunteers (14 vaccinees and 6 controls) to determine the safety and immunogenicity. Volunteers will be vaccinated with a single oral dose of 104 colony forming unit (cfu) of WRSS1 or placebo given with bicarbonate buffer.

- Part 2 will be started approximately 60 days after WRSS1 vaccination. This part is an inpatient phase II efficacy trial involving a challenge with the S.sonnei 53G of 10 vaccinees from the first part and 10 naïve controls.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2011
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

1. 20-40 years old; male or female;

2. General good health as determined by a screening evaluation no greater than 30 days before admission;

3. Normal bowel habits (grade 1-2 stools - no more than one to two stools per day with at least one stool per 2 days;

4. Sexually active females willing to use birth control (birth control pills, injection hormonal contraceptive, implant hormonal contraceptive, hormonal patch, IUD, sterilization for effective contraceptive methods, spermicidal products and barrier methods are considered acceptable)during the entire study (starting from study day -30) and for 3 months after completion of the study (approximately a total of 6 months) or sexually inactive females (no sexual contact). Volunteers who take birth control pills will be required to use additional contraceptive methods for the remaining days of the cycle after discharge from the VTC (alteration of gastrointestinal functions from the oral vaccine or challenge strain may lead to unpredictable efficacy of pills);

5. Will be available and willing to continue participation in the second part of the study if he/she has been randomly selected;

6. Pass the Assessment of Understanding of the consent form.

Exclusion Criteria:

1. An acute or chronic medical condition or a clinically significant abnormality on physical exam that, in the opinion of the investigator, would render vaccination or challenge as unsafe;

2. Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, OTC agents) or immunosuppressive drug;

3. Unwillingness to follow the study procedures

4. Currently breastfeeding, pregnant (ßHCG +) or planning to become pregnant within 3 months after the completion of the study;

5. Allergy to quinolone, sulfa, and penicillin classes of antibiotics;

6. History of any of the following conditions within the past 10 years:

- Arthritis (two or more episodes of joint pain and swelling),

- Gastrointestinal disease (diagnosed by a doctor as having irritable bowel disease, Crohn's disease, ulcerative colitis (biopsy confirmed), celiac disease, stomach or intestinal ulcers), or

- Dyspepsia (digestion or heartburn requiring medication more than once per week);

7. Lifetime previous history of known/suspected Shigella diarrhea (except for volunteers who receive vaccines from Part 1) ;

8. Lifetime history of, or active gallbladder disease;

9. HLA B27 Ag (+); Anti-HIV (+); HBsAg(+); Anti HCV IgG Ab(+); abnormal screening tests judged to be clinically significant as judged by PI or sub-PI (Values are out of the acceptable abnormal range from the table in the protocol) other than mild anemia in females (Hct = 0.33-0.36);

10. Lifetime history of participation in Shigella study (except for volunteers who receive vaccines from Part 1);

11. Concurrent participation in another experimental vaccine or drug study within the past 30 days(except for volunteers who receive vaccines from part1);

12. Serological positive for Shigella sonnei: anti-Shigella sonnei LPS IgG antibody titer in serum >800 (except for volunteers who receive vaccines from Part 1);

13. Receipt of antimicrobial drugs for any reason or acute illness or fever >=38 oC within 7 days before vaccination or challenge;

14. Individuals with household contacts that are immunocompromised;

15. History of major abdominal surgery or laparotomy for any reason in the past 3 years, or abdominal scar of unclear origin;

16. Presence of significant ova or parasite or Shigella bacteria in the stool;

17. Receipt of any of the following (does not include the WRSS1 vaccine):

- a licensed live, attenuated vaccine within the 30 days of challenge

- a licensed subunit or killed vaccine within the 14 days of the challenge

- a blood product, including immunoglobulin, in the 90 days before the challenge

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Part 1/Arm 1 of Study: WRSS1 vaccine
Single, oral dose of WRSS1
Part 1/Arm 2 of Study: Placebo vaccine
Placebo vaccine
Part 2/Arm 1 of Study: S. sonnei 53G
Subject from Part 1/Arm 1 of Study are given 53G S. sonnei
Part 2/Arm 2 of Study: S. sonnei 53G
10 naïve controls are given S. sonnei 53G

Locations

Country Name City State
Thailand Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University Bangkok

Sponsors (3)

Lead Sponsor Collaborator
U.S. Army Medical Research and Materiel Command Mahidol University, National Institutes of Health (NIH)

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events Overview of AEs highlighting all AEs, withdrawals and deaths related to AEs Up to 12 months
Primary Number of Participants With Shigella Induced Clinical Disease in Part 2 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. 0-5 days
Secondary Count of Subjects With Normal and Abnormal Clinical Laboratory Values During Parts 1 and 2 of Study 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 Days 1, 7, 14, and 28
See also
  Status Clinical Trial Phase
Completed NCT06283784 - Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients N/A
Recruiting NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis Phase 3
Completed NCT04003181 - The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon N/A
Completed NCT03596827 - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection N/A
Recruiting NCT05372068 - Cement flooRs AnD chiLd hEalth (CRADLE) N/A
Completed NCT03972618 - Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT05052489 - Registry and Clinical Observation of Children With Diarrhoeal Disease
Completed NCT02428647 - Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation N/A
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT01739231 - Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults Phase 1/Phase 2
Completed NCT01968408 - Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children Phase 3
Terminated NCT01048567 - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly Phase 2
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Not yet recruiting NCT01382199 - Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients Phase 3
Terminated NCT01472211 - Water-based Zinc Intervention Trial in Zinc Deficient Children Phase 0
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Completed NCT00914225 - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya N/A
Completed NCT00760851 - Yogurt Study in Children 2-4 Years Old Attending Daycare Phase 3