Shigella CVD 30000: Study of Responses to Vaccination With Shigella Vaccine (NCT04078022) | Clinical Trial Compass
CompletedPhase 2
Shigella CVD 30000: Study of Responses to Vaccination With Shigella Vaccine
United States58 participantsStarted 2020-03-02
Plain-language summary
The purpose of this study is to determine whether SF2a-TT15 (a monovalent synthetic carbohydrate-based conjugate Shigella vaccine) is safe and effective in the prevention of Shigella infection.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Male or female of age 18-45 years
* Provides written informed consent
* Healthy, based on history, exam, and medications
* Documented acceptable screening laboratory work, including:
WBC, ANC, Hg, Platelets Creatinine, ALT, Bili Serum IgA HIV, HBsAg, HCV Negative for HLA-B27 (this criterion does not apply to cohort 4) Stool culture urinalysis
* Passing score on Comprehension Assessment Tool (greater than or equal to 70 percent correct answers)
* Agrees not to participate in another interventional clinical trial during the study period
* For females of child-bearing potential, must agree to acceptable birth control, 4 weeks before enrollment and through 4 weeks after last vaccination or challenge
* Available for a 12-day inpatient stay (this criterion does not apply to cohort 4)
Exclusion Criteria:
* Positive pregnancy test at screening or within 24 hours of study product dosing
* Poor venous access, as defined by inability to obtain venous blood after 3 venipuncture attempts (this criterion does not apply to cohort 4)
* Abnormal vital signs, defined as:
Systolic BP greater than 150 mmHg or Diastolic BP greater than 90 mmHg Resting heart rate greater than 100 Oral temperature greater than or equal to 100.4 degrees F
* Persons with IgA deficiency (serum IgA less than 70 mg per dL
* Serum S. flexneri 2a LPS igG titer greater than or equal to 2500
* Received prior vaccines or had prior infection (natural or challenge) with ETEC or Shigella, within 5 y…
What they're measuring
1
Number of Participants With Moderate-Severe Shigellosis Illness, With Challenge