First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Inventprise Inc.
Study ID
NCT07205926
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Diarrhea
  • Shigella

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • IVT Shigella-04 — BIOLOGICAL
    Preventative vaccine for Shigella protection against 4 unique serotypes
  • Placebo (0.9% saline) — BIOLOGICAL
    Subjects dosed with 0.9% saline

Study Details

Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults

Key Dates

Start date
Oct 9, 2025
Status verified
Nov 2025
Primary completion
Jan 26, 2026
Completion
Aug 21, 2026

Study Design

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

Arms

  • Experimental: Shigella-04 Low Dose without adjuvant (0.5 mL dose)
    Subjects will receive a 0.5 mL dose of the Shigella-04 low-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29
  • Experimental: Shigella-04 Low Dose with adjuvant (0.5 mL dose)
    Subjects will receive a 0.5 mL dose of the Shigella-04 low-dose formulation of each conjugated OPS, with adjuvant, administered via intramuscular injection on Day 1 and 29
  • Experimental: Shigella-04 Medium Dose without adjuvant (0.5 mL dose)
    Subjects will receive a 0.5 mL dose of the Shigella-04 medium-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29
  • Experimental: Shigella-04 Medium Dose with adjuvant (0.5 mL dose)
    Subjects will receive a 0.5 mL dose of the Shigella-04 medium-dose formulation of each conjugated OPS, with adjuvant, administered via intramuscular injection on Day 1 and 29
  • Experimental: Shigella-04 High Dose without adjuvant (1.0 mL dose)
    Subjects will receive a 1.0 mL dose of the Shigella-04 high-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29
  • Placebo Comparator: Placebo - 0.9% Saline
    0.9% saline

Primary Outcome Measure

Percentage of participants with reactogenicity events for 7 days after each dose [ Time Frame: 7 days after Doses 1 and 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medpace Clinical Pharmacology UnitCincinnatiOhio45227
Medpace Clinical Pharmacology Unit
[email protected]
513-366-3222

Find similar trials in Cincinnati, OH

By research site
Medpace Clinical Pharmacology Unit· Cincinnati, OH

Related Studies