Search / Trial NCT06615375

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

Launched by LIMMATECH BIOLOGICS AG · Sep 24, 2024

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is testing a new vaccine called Shigella4V2, designed to protect against a bacterial infection known as shigellosis, which can cause severe diarrhea and stomach pain. The study is specifically looking for healthy adults aged 18 to 50 who are willing to participate. To be eligible, participants must be in good health, not pregnant, and must agree to use effective birth control during the study. Participants will either receive the vaccine or a placebo (a dummy treatment with no active ingredients) and will be monitored to see how well the vaccine helps their body fight off the infection.

Those who join the trial can expect to undergo health screenings and provide informed consent before receiving the vaccine. They will need to attend follow-up visits and phone calls throughout the study. It's important to note that individuals with certain health conditions, recent vaccinations, or those who have traveled to areas where shigellosis is common may not qualify. This study is a step towards finding a potential vaccine to help prevent shigellosis, which could help millions of people in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Step 1 \& Step 2:
  • 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.
  • Step 2 only:
  • 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.
  • Exclusion Criteria:
  • Step 1 \& Step 2:
  • 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.
  • Step 2 only:
  • 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.

Trial Officials

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

About Limmatech Biologics Ag

Limmatech Biologics AG is a pioneering biotechnology company focused on the development and commercialization of innovative biologic therapies. With a commitment to advancing healthcare solutions, Limmatech leverages cutting-edge research and technology to create novel biologics that target unmet medical needs across various therapeutic areas. The company emphasizes rigorous clinical trial methodologies and collaborative partnerships to ensure the efficacy and safety of its products. Limmatech Biologics AG is dedicated to improving patient outcomes through the discovery and development of transformative therapies that harness the power of biological science.

Locations

Atlanta, Georgia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0