RECRUITING

A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2b, Double-blind, Placebo-controlled Efficacy Challenge Study with the Shigella Tetravalent Bioconjugate Vaccine Shigella4V2

Quick Facts

Study Start:2024-11-12

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06615375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18-50 years (inclusive). 2. In good health and stable medical condition, determined by MH, laboratory results, and physical examination during screening period. 3. Negative pregnancy test at the time of injection, for participants of childbearing potential. 4. Persons of childbearing potential must agree to avoid pregnancy by use of effective contraception for 30 days prior to 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). 5. Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained. 6. Availability for the study duration, including all planned follow-up visits and phone calls. 7. Willingness to refrain from participating in other studies of investigational products until completion of the last study contact. 8. 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.	1. Participants currently pregnant, lactating, or intending to become pregnant during the study period as reported by the participant. 2. Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study. 3. Clinically significant abnormalities in vital signs or in screening hematology / blood chemistry as determined by the investigator. 4. 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)). 5. Evidence of current excessive alcohol consumption or drug dependence (e.g. according to medical history). 6. Known or suspected impairment of immunological function (e.g., documented HIV infection, asplenia/splenectomy, or history of autoimmune disease or lymphoproliferative disorder). 7. BMI \< 19 or \> 35 kg/m2. 8. Recent vaccination or planned vaccination within 14 days of study injection for inactivated vaccines and within 30 days for live vaccines. 9. Recent receipt of an investigational product within 30 days preceding the study injection or planned during the entire study period. 10. Recent treatment with immunoglobulins or blood products within 3 months preceding the study injection or planned use during the entire study period. 11. Use of any medication known to affect the immune function (e.g., systemic steroids) within 30 days preceding the study injection or planned use during the entire study period. 12. Symptoms consistent with Traveler's Diarrhea concurrent with travel to countries where Shigella infection is endemic (most of the developing world). 13. Vaccination for or ingestion of Shigella. 14. Use of systemic antibiotics during the 7 days before injection. 15. Serum IgG titers to S. sonnei LPS ≥ 2500. 16. Current occupation involving the handling of Shigella bacteria. 17. History of allergy to components of the study vaccine (Alhydrogel), to placebo (PBS), or to soy, or any other allergy the investigator deems to increase their risk of AEs in the study. 18. Any other criteria which, in the investigator's opinion, would compromise the ability of the participant to participate in the study, the safety of the study, or the results of the study. 19. Part of study personnel or close family member of personnel conducting the study. 20. Personal history of inflammatory ReA. 21. Positive blood test for HLA-B27 antigen. 22. Personal history of IBS as defined by Rome IV criteria. 23. Regularly abnormal stool pattern (fewer than 3 per week or more than 3 per day). 24. Regular use of laxatives, antacids, or other agents to lower stomach acidity. 25. Known allergy to challenge agent components. 26. Known allergy to ciprofloxacin or trimethoprim-sulfamethoxazole. 27. Evidence of IgA deficiency (serum IgA \< 7 mg/dL or limit of detection of assay). 28. Planning to travel to Shigella endemic countries before completion of the challenge phase of the study. 29. Personal history of inflammatory bowel disease.

Inclusion Criteria

Exclusion Criteria

1. Age 18-50 years (inclusive).
2. In good health and stable medical condition, determined by MH, laboratory results, and physical examination during screening period.
3. Negative pregnancy test at the time of injection, for participants of childbearing potential.
4. Persons of childbearing potential must agree to avoid pregnancy by use of effective contraception for 30 days prior to 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).
5. Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
6. Availability for the study duration, including all planned follow-up visits and phone calls.
7. Willingness to refrain from participating in other studies of investigational products until completion of the last study contact.
8. 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.

1. Participants currently pregnant, lactating, or intending to become pregnant during the study period as reported by the participant.
2. Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study.
3. Clinically significant abnormalities in vital signs or in screening hematology / blood chemistry as determined by the investigator.
4. 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)).
5. Evidence of current excessive alcohol consumption or drug dependence (e.g. according to medical history).
6. Known or suspected impairment of immunological function (e.g., documented HIV infection, asplenia/splenectomy, or history of autoimmune disease or lymphoproliferative disorder).
7. BMI \< 19 or \> 35 kg/m2.
8. Recent vaccination or planned vaccination within 14 days of study injection for inactivated vaccines and within 30 days for live vaccines.
9. Recent receipt of an investigational product within 30 days preceding the study injection or planned during the entire study period.
10. Recent treatment with immunoglobulins or blood products within 3 months preceding the study injection or planned use during the entire study period.
11. Use of any medication known to affect the immune function (e.g., systemic steroids) within 30 days preceding the study injection or planned use during the entire study period.
12. Symptoms consistent with Traveler's Diarrhea concurrent with travel to countries where Shigella infection is endemic (most of the developing world).
13. Vaccination for or ingestion of Shigella.
14. Use of systemic antibiotics during the 7 days before injection.
15. Serum IgG titers to S. sonnei LPS ≥ 2500.
16. Current occupation involving the handling of Shigella bacteria.
17. History of allergy to components of the study vaccine (Alhydrogel), to placebo (PBS), or to soy, or any other allergy the investigator deems to increase their risk of AEs in the study.
18. Any other criteria which, in the investigator's opinion, would compromise the ability of the participant to participate in the study, the safety of the study, or the results of the study.
19. Part of study personnel or close family member of personnel conducting the study.
20. Personal history of inflammatory ReA.
21. Positive blood test for HLA-B27 antigen.
22. Personal history of IBS as defined by Rome IV criteria.
23. Regularly abnormal stool pattern (fewer than 3 per week or more than 3 per day).
24. Regular use of laxatives, antacids, or other agents to lower stomach acidity.
25. Known allergy to challenge agent components.
26. Known allergy to ciprofloxacin or trimethoprim-sulfamethoxazole.
27. Evidence of IgA deficiency (serum IgA \< 7 mg/dL or limit of detection of assay).
28. Planning to travel to Shigella endemic countries before completion of the challenge phase of the study.
29. Personal history of inflammatory bowel disease.

Contacts and Locations

Study Contact

Bettina Wunderlich, PhD

CONTACT

+41447338555

bettina.wunderlich@lmtbio.com

Principal Investigator

Kawsar R Talaat, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Paulina A Rebolledo, MD

PRINCIPAL_INVESTIGATOR

Emory University

Robert W Frenck, Jr., MD

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Hope Clinic of Emory University

Atlanta, Georgia, 30030

United States

Collaborators and Investigators

Sponsor: LimmaTech Biologics AG

Kawsar R Talaat, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health
Paulina A Rebolledo, MD, PRINCIPAL_INVESTIGATOR, Emory University
Robert W Frenck, Jr., MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-12

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-11-12

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Shigellosis