Health Trials

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

ConditionsShigellaDiarrhea
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-49
SponsorInventprise Inc.

About this trial

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

Eligibility criteria

Qualifiers

Age 18 to 49 years at the time of Dose 1

Good general health status, as determined by medical history, physical examination, safety laboratory tests, ECG, vital signs, and clinical judgment

BMI ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2

Negative alcohol breath test and urine drug screen results at Screening and on Day 1

Disqualifiers

Currently lactating

History of shigellosis or participation in a Shigella challenge study

History of bloody diarrhea without alternative diagnosis

History of inflammatory bowel disease

Trial design

Treatments tested in this trial

  • IVT Shigella-04
  • Placebo (0.9% saline)

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Inventprise Inc.

Lead sponsor

Source ClinicalTrials.gov