First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
- Conditions
- ShigellaDiarrhea
- Interventions
- Biological: IVT Shigella-04Biological: Placebo (0.9% saline)
- Registration Number
- NCT07205926
- Lead Sponsor
- Inventprise Inc.
- Brief Summary
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Shigella-04 Low Dose without adjuvant (0.5 mL dose) IVT Shigella-04 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 Shigella-04 Low Dose with adjuvant (0.5 mL dose) IVT Shigella-04 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 Shigella-04 Medium Dose without adjuvant (0.5 mL dose) IVT Shigella-04 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 Shigella-04 Medium Dose with adjuvant (0.5 mL dose) IVT Shigella-04 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 Shigella-04 High Dose without adjuvant (1.0 mL dose) IVT Shigella-04 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 - 0.9% Saline Placebo (0.9% saline) 0.9% saline
- Primary Outcome Measures
Name Time Method Percentage of participants with reactogenicity events for 7 days after each dose 7 days after Doses 1 and 2 To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 2 After Dose 1 to 6 months after Dose 2 To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with medically attended AE's (MAAEs) from Dose 1 to 6 months after Dose 2 After Dose 1 to 6 months after Dose 2 To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from Dose 1 to 6 months after Dose 2 After Dose 1 to 6 months after Dose 2 To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with AEs of special interest (AESIs) from Dose 1 to 6 months after Dose 2 After Dose 1 to 6 months after Dose 2 To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with serious AEs (SAEs) from Dose 1 to 6 months after Dose 2 After Dose 1 to 6 months after Dose 2 To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
- Secondary Outcome Measures
Name Time Method Percentage of participants achieving 4-fold increase in anti-IpaB and serotype-specific anti-OPS immunoglobulin G (IgG) concentration at 28 days after each dose and 6 months after Dose 2 At 28 days after each dose and 6 months after Dose 2 To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Geometric mean concentration (GMCs) of anti-IpaB and serotype-specific anti-OPS IgG at 28 days after each dose and 6 months after Dose 2 At 28 days after each dose and 6 months after Dose 2 To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Geometric mean fold rises (GMFRs) in anti-IpaB and serotype-specific anti-OPS IgG concentration at 28 days after each dose and 6 months after Dose 2 At 28 days after each dose and 6 months after Dose 2 To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants achieving 4-fold increase in serotype-specific anti-OPS functional antibody titer measured by serum bactericidal assay (SBA) at 28 days after each dose At 28 days after each dose To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Geometric mean titers (GMTs) of serotype-specific anti-OPS functional antibody as measured by SBA at 28 days after each dose At 28 days after each dose To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
GMFRs in serotype-specific anti-OPS functional antibody titer as measured by SBA at 28 days after each dose At 28 days after each dose To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Trial Locations
- Locations (1)
Medpace Clinical Pharmacology Unit
🇺🇸Cincinnati, Ohio, United States
Medpace Clinical Pharmacology Unit🇺🇸Cincinnati, Ohio, United StatesMedpace Clinical Pharmacology UnitContact513-366-3222studyrecruitment@medpace.com