Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Eveliqure Biotechnologies GmbH
Study ID
NCT07049159
Phase
PHASE2
Status
Recruiting
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Conditions

  • Shigella

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • ShigETEC vaccine — BIOLOGICAL
    The ShigETEC vaccine will be administered orally 4 times at 3-day intervals as a bacterial suspension in a volume of 30 mL per dose (target to contain 5x10\^10 CFU)
  • Placebo — OTHER
    Eligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10\^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10.
  • Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU — BIOLOGICAL
    In the challenge stage all participants will receive 1 oral dose of Shigella flexneri 2457T at a dose of 1.5x10\^3 CFU.

Study Details

The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T. In Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10\^10 CFU. This dose was tested in a Phase 1 trial and found to be safe when given 4 times with an interval of 3 days between each dose. The efficacy of ShigETEC vaccination will be evaluated in Stage 2 of this study, when participants will be challenged with S. flexneri 2457T. The study population will be healthy adult participants in the age of 18-50 years (inclusive), which are clearly defined in the study protocol.

Key Dates

Start date
Jun 30, 2025
Status verified
Jun 2025
Primary completion
May 23, 2027
Completion
May 23, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: ShigETEC, a live, attenuated, oral vaccine
    Eligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10\^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10.
  • Placebo Comparator: Placebo
    Eligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10\^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10.

Primary Outcome Measure

Efficacy of the ShigETEC vaccine in preventing shigellosis caused by the challenge strain [ Time Frame: Up to study day 60 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Immunization ResearchBaltimoreMaryland21205
Kawsar Talaat

Find similar trials in Baltimore, MD

By research site
Center for Immunization Research· Baltimore, MD

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