NCT04415749

NasoShield in Healthy Adults to Study Safety and Immunogenicity

A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Immunogenicity of NasoShield Administered as One or Two Doses in Different Dosing Positions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Altimmune, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to determine if antibodies that protect against anthrax are formed after treatment with NasoShield, and to determine whether the formation of these antibodies are affected by different positions of administration.

Detailed description

After being informed about the study and potential risks, all healthy volunteers that have given written informed consent will undergo screening to determine eligibility for study entry. If the healthy volunteer qualifies for the study, they will be randomly assigned to 1 of 3 treatment groups. Within the treatment group, the participant will be randomized in a double-blind manner in a 5:2 ratio to NasoShield or placebo. The investigational drug (either NasoShield or placebo) will be administered on Days 1 and 29 after qualifying into the study. The position of administration and the amount of time the subject will need to stay in the specified position will depend on the group to which the subject is assigned. Participants will return to the investigational site for multiple visits through Day 210 (approximately 6 months after the second dose). At each visit, the participant will be asked about interim medical history and use of any medications, and safety and immunogenicity assessments will be performed.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	NasoShield	NasoShield is an adenovirus-vectored anthrax vaccine
OTHER	Placebo	Normal saline

Timeline

• Start date: 2020-06-15
• Primary completion: 2021-03-15
• Completion: 2021-03-15
• First posted: 2020-06-04
• Last updated: 2025-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study