Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • IVT Shigella-04

    Biological/Vaccine

    Preventative vaccine for Shigella protection against 4 unique serotypes

  • Placebo (0.9% saline)

    Biological/Vaccine

    Subjects dosed with 0.9% saline

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Shigella-04 Low Dose without adjuvant (0.5 mL dose)Experimental treatment 1 intervention
Group B: Shigella-04 Low Dose with adjuvant (0.5 mL dose)Experimental treatment 1 intervention
Group C: Shigella-04 Medium Dose without adjuvant (0.5 mL dose)Experimental treatment 1 intervention
Group D: Shigella-04 Medium Dose with adjuvant (0.5 mL dose)Experimental treatment 1 intervention
Group E: Shigella-04 High Dose without adjuvant (1.0 mL dose)Experimental treatment 1 intervention
Group F: Placebo - 0.9% SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants with reactogenicity events for 7 days after each dose

To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04

Time frame
7 days after Doses 1 and 2
2

Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 2

To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04

Time frame
After Dose 1 to 6 months after Dose 2
3

Percentage of participants with medically attended AE's (MAAEs) from 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

Time frame
After Dose 1 to 6 months after Dose 2
4

Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from 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

Time frame
After Dose 1 to 6 months after Dose 2

Secondary outcomes

1

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

To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04

Time frame
At 28 days after each dose and 6 months after Dose 2
2

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

To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04

Time frame
At 28 days after each dose and 6 months after Dose 2
3

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

To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04

Time frame
At 28 days after each dose and 6 months after Dose 2
4

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

To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04

Time frame
At 28 days after each dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inventprise Inc.

Lead sponsor

Source ClinicalTrials.gov
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