First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Safety and Immunogenicity of IVT Shigella-04 in Healthy Young Adults
Inventprise Inc.
Summary
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
Description
A phase 1 single-site, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of a 2-dose regimen of IM injection of 5 dose formulations of IVT Shigella-04 vaccine with and without adjuvant among 60 healthy individuals aged 18 to 49 years. Approximately 12 eligible participants will be enrolled in the specified 5 sequential dose cohorts and randomized in a 5:1 ratio to receive 2 IM injections of IVT Shigella-04 or placebo (normal saline) at a 28-day interval.
Eligibility
- Age range
- 18–49 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria Participants who meet all the following criteria may be included in the study: 1. Age 18 to 49 years at the time of Dose 1 2. Good general health status, as determined by medical history, physical examination, safety laboratory tests, ECG, vital signs, and clinical judgment 3. BMI ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 4. Negative alcohol breath test and urine drug screen results at Screening and on Day 1 5. All women: negative serum pregnancy test at Screening and negative urine pregnancy on Day 1 6. Women of childbearing potential (see definition in Section 6.6.1): willingness to…
Interventions
- BiologicalIVT Shigella-04
Preventative vaccine for Shigella protection against 4 unique serotypes
- BiologicalPlacebo (0.9% saline)
Subjects dosed with 0.9% saline
Location
- Medpace Clinical Pharmacology UnitCincinnati, Ohio