NCT03869333

Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]

A Phase 1 Double-blind, Placebo-controlled, Dose Escalating Study of Intramuscular Detoxified Shigella Flexneri 2a Artificial Invasin Complex (Invaplex[AR-DETOX]) Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	Invaplex[AR-DETOX]	Detoxified Shigella flexneri 2a Artificial Invasin Complex (Invaplex\[AR-Detox\]) Vaccine
OTHER	Placebo	Saline

Timeline

• Start date: 2019-03-18
• Primary completion: 2020-06-12
• Completion: 2020-06-12
• First posted: 2019-03-11
• Last updated: 2021-07-29
• Results posted: 2021-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study