A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine (NCT06615375) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine
United States120 participantsStarted 2024-11-12
Plain-language summary
In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain compared to participants receiving placebo.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Age 18-50 years (inclusive).
✓. In good health and stable medical condition, determined by MH, laboratory results, and physical examination during screening period.
✓. Negative pregnancy test at the time of 1st injection, for participants of childbearing potential.
✓. Persons of childbearing potential must agree to avoid pregnancy by use of effective contraception for 30 days prior to 1st injection and throughout the study. Participants assigned female at birth and unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
✓. Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
✓. Availability for the study duration, including all planned follow-up visits and phone calls.
✓. Willingness to refrain from participating in other studies of investigational products until completion of the last study contact.
✓. Demonstrated comprehension of the protocol procedures, knowledge of Shigella- associated illness, and passing score of 70% or better on a comprehension assessment. Maximum two attempts are allowed.
Exclusion criteria
✕. Participants currently pregnant, lactating, or intending to become pregnant during the study period as reported by the participant.
✕. Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study.
What they're measuring
1
To demonstrate that the Shigella4V2 bioconjugate vaccine protects against shigellosis following challenge with the wild type S. sonnei 53G strain.
Timeframe: To be evaluated post-challenge during the inpatient period (Day 56 through Day 65) in vaccinees vs. placebo
✕. Clinically significant abnormalities in vital signs or in screening hematology / blood chemistry as determined by the investigator.
✕. Presence in the serum of HIV 1/2 antibody, HBs-Ag, or HCV antibody (if confirmed positive by Hepatitis C confirmatory test, i.e., recombinant immunoblot assay (RIBA), polymerase chain reaction (PCR)).
✕. Evidence of current excessive alcohol consumption or drug dependence (e.g. according to medical history).
✕. Known or suspected impairment of immunological function (e.g., documented HIV infection, asplenia/splenectomy, or history of autoimmune disease or lymphoproliferative disorder).
✕. BMI \< 19 or \> 35 kg/m2.
✕. Recent vaccination or planned vaccination within 14 days of 1st study injection for inactivated vaccines and within 30 days for live vaccines.