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Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]

NCT03869333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-07-29

Study results available
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Summary

The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex\[AR-Detox\]) vaccine candidate administered by intramuscular immunization.

Conditions

Interventions

BIOLOGICAL

Invaplex[AR-DETOX]

Detoxified Shigella flexneri 2a Artificial Invasin Complex (Invaplex\[AR-Detox\]) Vaccine

OTHER

Placebo

Saline

Sponsors & Collaborators

  • PATH

    lead OTHER

Principal Investigators

  • Ramiro Gutierrez, MD, MPH · Naval Medical Research Center (NMRC)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2020-06-12
Completion
2020-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869333 on ClinicalTrials.gov