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NasoShield Study of Safety and Immunogenicity

NCT03352466 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2025-06-24

No results posted yet for this study

Summary

This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

NasoShield

NasoShield is an adenovirus-vectored anthrax vaccine.

BIOLOGICAL

BioThrax

Commercially available anthrax vaccine

OTHER

Placebo

Normal saline

Sponsors & Collaborators

  • Altimmune, Inc.

    lead INDUSTRY

Principal Investigators

  • Emanuel DeNoia, MD · ICON plc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2019-05-13
Completion
2019-05-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03352466 on ClinicalTrials.gov