First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
NCT07205926 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-11-19
Summary
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
Conditions
- Shigella
- Diarrhea
Interventions
- BIOLOGICAL
-
IVT Shigella-04
Preventative vaccine for Shigella protection against 4 unique serotypes
- BIOLOGICAL
-
Placebo (0.9% saline)
Subjects dosed with 0.9% saline
Sponsors & Collaborators
-
Inventprise Inc.
lead INDUSTRY
Principal Investigators
-
Chief Medical Officer · Inventprise Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-09
- Primary Completion
- 2026-01-26
- Completion
- 2026-08-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection
NCT04626856 ·Status: UNKNOWN ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
NCT01544361 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
NCT04449276 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study of BLB-201 Vaccine in Healthy Young and Older Adults
NCT05281263 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating Single Doses of ILV-095 in Healthy Subjects
NCT00822835 ·Status: COMPLETED ·Phase: PHASE1
-
TY800 Dose Escalation (Typhoid)
NCT00269295 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001).
NCT06655324 ·Status: RECRUITING ·Phase: PHASE1
-
Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V
NCT00097396 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) Post-Vaccination
NCT07330440 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE1
-
Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884
NCT03001297 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects
NCT02669667 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age
NCT05995275 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety of Sublingual dmLT for ETEC
NCT02052934 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 2 Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants
NCT07205796 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Trial for Safety and Immunogenicity of a Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults
NCT02562482 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
NCT06221813 ·Status: COMPLETED ·Phase: PHASE1
-
Study To Assess Local Tolerability of Crisaborole 2% Ointment and Vehicle Ointment In Healthy Participants Using Subject-reported Assessments and Objective Measurements
NCT03760042 ·Status: COMPLETED ·Phase: PHASE1
-
Salmonella Conjugates CVD 1000: Study of Responses to Vaccination With Trivalent Invasive Salmonella Disease Vaccine
NCT03981952 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults
NCT02547792 ·Status: COMPLETED ·Phase: PHASE1
-
A Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects
NCT01756131 ·Status: COMPLETED ·Phase: PHASE1
-
First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers
NCT01459562 ·Status: COMPLETED ·Phase: PHASE1
-
A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)
NCT01732848 ·Status: COMPLETED
-
Safety and Immunogenicity of Recombinant COVID-19 Trivalent Protein Vaccine (CHO Cell)LYB002V14 in Booster Vaccination
NCT06167915 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects
NCT04893512 ·Status: COMPLETED ·Phase: PHASE1
-
Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults
NCT05398796 ·Status: COMPLETED ·Phase: PHASE1