Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, Phase 1 clinical trial in which a total of 60 volunteers will receive one of three doses of Invaplex[AR-DETOX] or placebo (saline). The vaccine will be administered via intramuscular (IM) injection on study days 1, 22, and 43. Each participant will receive the same formulation at each vaccination dependent upon group assignment. The study will be initiated with the lowest dose level (2.5 μg) and will proceed to the next highest dose in an escalating fashion. All safety data will be summarized and reviewed by the Protocol Safety Review Team (PSRT) prior to dose-escalation. Specimens will be collected at prescribed intervals to examine systemic and mucosal immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose. ;

Study Design

Related Conditions & MeSH terms

Diarrhea

Clinical Trial Details

NCT number	NCT03869333
Study type	Interventional
Source	PATH
Contact
Status	Completed
Phase	Phase 1
Start date	March 18, 2019
Completion date	June 12, 2020

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