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Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates. An adaptable dosing plan was used to determine the dose of Shigella sonnei 53G that induces the primary outcome in approximately 60% of subjects.
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Secondary objectives:
Enrollment
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Inclusion criteria
Male or non-pregnant female between 18 and 49 years of age (inclusive).
General good health defined as (a) no significant medical illness, (b) no clinically significant physical examination findings and (c) no screening laboratory values significantly outside the normal limits of the testing laboratory within 45 days of challenge.
Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (pass grade ≥70%) on day -1.
Willing to sign an informed consent form (ICF).
Willingness to participate for an inpatient stay lasting up to 11 days and an outpatient follow-up lasting 6 months from challenge.
Willing to not smoke during the inpatient stay.
Available for all planned follow-up visits.
Negative serum pregnancy test at screening and negative urine pregnancy test on the day of admission to the inpatient phase for female subjects of childbearing potential. Females of childbearing potential must agree to use an effective method of birth control (birth control pills, injection hormonal contraceptive, implant hormonal contraceptive,
hormonal patch, intrauterine device (IUD), sterilization by hysterectomy or tubal ligation, spermicidal products and barrier methods such as cervical sponge, diaphragm, or condom) within two months of challenge and during the entire study. Abstinence is acceptable. A woman is eligible if she is monogamous with a vasectomized partner.
Willing to not donate blood for up to 6 months after completion of the inpatient phase of the study.
Willing to refrain from participation in another investigational vaccine or drug trial at least until after completion of the 6 month follow-up safety call.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
56 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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