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Shigella WRSS1 Vaccine Trial in Bangladesh

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ClinicalTrials.gov Identifier: NCT02934178
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
PATH

Brief Summary:
This is a research study about an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response. Shigella causes bloody and watery diarrhea, and infants and children living in developing countries experience the greatest consequences of this disease. The WRSS1 vaccine in will be given to healthy toddlers (12-24 months old). The first vaccination will be given to toddlers in the inpatient unit and the second and third doses will be administered on an outpatient basis. A safety evaluation will be preformed after the first dose before enrolling subjects in subsequent cohorts to receive a higher vaccine dose. As of September 2017, the study will be close out after Cohort 1 and enrollment of Cohorts 2, 3 and 4 will not occur.

Condition or disease Intervention/treatment Phase
Diarrhea Biological: WRSS1 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1 Randomized, Double-Blinded, Placebo-controlled, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Live Attenuated, Oral Shigella WRSS1 Vaccine in Bangladeshi Toddlers (12 to 24 Months Old)
Study Start Date : November 2016
Actual Primary Completion Date : January 10, 2018
Actual Study Completion Date : January 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Cohort 1
3 oral doses of 3x10^3 cfu WRSS1 12 participants, 4 placebo
Biological: WRSS1
Experimental: Cohort 2
3 oral doses of 3x10^4 cfu WRSS1 12 participants, 4 placebo
Biological: WRSS1
Experimental: Cohort 3
3 oral doses of 3x10^5 cfu WRSS1 12 participants, 4 placebo
Biological: WRSS1
Experimental: Cohort 4
3 oral doses of 3x10^6 cfu WRSS112 participants, 4 placebo
Biological: WRSS1



Primary Outcome Measures :
  1. Solicited reactogenicity, unsolicited AE, SAEs, unsolicited AEs and SAEs judged as having a reasonable possibility that the study product caused the event [ Time Frame: 2 year follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female children aged between 12 to 24 month of age at the time of vaccination
  2. General good health as determined by the screening evaluation no greater than 30 days before admission
  3. Father, mother or other legally acceptable representative (guardian) properly informed about the study, able to understand it and sign the informed consent form
  4. Normal bowel habits (< 3 grade 1 or2 stools each day; ≥ 1 grade 1 or 2 stools every 2 days)
  5. Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  6. Parent or guardian available for the entire period of the study and reachable by study staff throughout the entire follow-up period.
  7. Signed Informed Consent from the Parent or legal guardian

Exclusion Criteria:

  1. Presence of a significant medical that in the opinion of the Investigator precludes participation in the study
  2. Known infection with HIV
  3. Presence in the serum of HAV or HCV antibody.
  4. History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder.
  5. Participation in research involving another investigational product (defined as receipt of investigational product) 30 days before planned date of first vaccination or concurrently participating in another clinical study, at any time during the study period, in which the child has been or will be exposed to an investigational or a non-investigational product
  6. Clinically significant abnormalities on physical examination
  7. Clinically significant abnormalities in screening hematology, serum chemistry as determined by the PI or the PI in consultation with the Study Physician
  8. History of febrile illness within 48 hours prior to vaccination
  9. Known or suspected impairment of immunological function based on medical history and physical examination
  10. Prior receipt of any Shigella vaccine
  11. Fever at the time of immunization. Fever is defined as a temperature ≥ 37.5C (99.5F) on axillary, oral, or tympanic measurement
  12. History of known shigellosis, chronic diarrhea/dysentery in the past 2 months
  13. Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazol, OTC agents) or immunosuppressive drug
  14. Allergy to quinolone, sulfa, and penicillin classes of antibiotics
  15. Clinical evidence of active gastrointestinal illness
  16. Prior receipt of a blood transfusion or blood products, including immunoglobulins
  17. Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol.
  18. History of any neurologic disorders or seizures.
  19. Acute disease at the time of enrolment
  20. Medically significant malnutrition, defined as moderate malnutrition (wt-for-age z-score between -3.0 and -2.0) and severe malnutrition (wt-for-age z-score <-3.0 or edema)
  21. Any conditions which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives
  22. Receipt of antimicrobial drugs for any reason or a fever ≥ 38C within 7 days before vaccination
  23. History of diarrhea during the 7 days before vaccination.
  24. Has any household member(s) who is immunocompromised or under the age of 1 year old.
  25. Culture or PCR positive for any Shigella strain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934178


Locations
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Bangladesh
Mirpur Field Office
Bangladesh, Bangladesh
Sponsors and Collaborators
PATH
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Rubhana Raqib, MD International Centre for Diarrhoeal Disease Research, Bangladesh

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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02934178     History of Changes
Other Study ID Numbers: VAC-049
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Keywords provided by PATH:
shigellosis
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms