NasoShield Study of Safety and Immunogenicity

NCT03352466 | Completed Phase 1 FDA Drug

• 1 other identifier: ALT201-101
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Anthrax

Outcome Measures

Primary Outcomes (2)

• Reactogenicity

  Subjects will record solicited local and systemic events for 14 days after each dose

  For 14 days after vaccination

• Adverse events (AEs)

  All adverse events from Day 1 to Day 57, SAEs, medically attended AEs and new onset chronic illnesses Day 1 to Day 361

  From Day 1 to Day 361

Secondary Outcomes (2)

• Anti-PA immunoglobulin G (IgG)

  From Day 1 to Day 361

• Toxin neutralization assay (TNA)

  From Day 1 to Day 361

Study Arms (7)

NasoShield very low dose - 1 X 10^8 vp

EXPERIMENTAL

Single intranasal spray (Part A)

Biological: NasoShield

NasoShield low dose - 1 X 10^9 vp

EXPERIMENTAL

Single intranasal spray (Part A)

Biological: NasoShield

NasoShield medium dose - 1 X 10^10 vp

EXPERIMENTAL

Single intranasal spray (Part A)

Biological: NasoShield

NasoShield high dose - Part A -1 X 10^11 vp

EXPERIMENTAL

Single intranasal spray (Part A)

Biological: NasoShield

NasoShield high dose - Part B - 1 X 10^11 vp

EXPERIMENTAL

2 intranasal sprays 21 days apart (Part B)

Biological: NasoShield

Placebo

PLACEBO COMPARATOR

Normal saline, single intranasal spray (Part A) or two intranasal sprays 21 days apart (Part B)

Other: Placebo

BioThrax

ACTIVE COMPARATOR

Three intramuscular injections 15 days apart (Part A)

Biological: BioThrax

Interventions

NasoShield BIOLOGICAL

NasoShield is an adenovirus-vectored anthrax vaccine.

NasoShield high dose - Part A -1 X 10^11 vp; NasoShield high dose - Part B - 1 X 10^11 vp; NasoShield low dose - 1 X 10^9 vp; NasoShield medium dose - 1 X 10^10 vp; NasoShield very low dose - 1 X 10^8 vp

BioThrax BIOLOGICAL

Commercially available anthrax vaccine

BioThrax

Placebo OTHER

Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women 18 to 49 years of age, inclusive
• Good general health status as determined by the Investigator
• Adequate venous access for repeated phlebotomies
• Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome
• Negative drug and alcohol screen at Screening and predose on Day 1
• For women who have not been surgically sterilized and do not have laboratory confirmation of postmenopausal status, negative pregnancy test
• Willingness to practice a highly effective method of contraception: abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the last IP dose
• Willingness to participate and comply with all aspects of the study through the entire study period, including nasopharyngeal swabs and blood and urine samples
• Provision of written informed consent

You may not qualify if:

• Pregnant, possibly pregnant, or lactating women
• Household contacts of pregnant women, children \< 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
• Persons who care for pregnant women, children \< 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
• Body mass index \> 35.0 kg/m2
• Positive result for HIV, hepatitis B virus, or hepatitis C virus at Screening
• Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following events in the past year:
• Daily symptoms
• Daily use of short acting beta 2 agonists
• Use of inhaled steroids or theophylline
• Use of pulse systemic steroids
• Emergency care or hospitalization related to asthma or other chronic lung disease
• Systemic steroids for asthma exacerbation
• History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
• History of coronary artery disease, arrhythmia, or congestive heart failure
• Clinically significant ECG abnormality as determined by the Investigator

Sponsors & Collaborators

• Altimmune, Inc.: lead

Study Sites (2)

Optimal Research, LLC

Melbourne, Florida, 32934, United States

Location

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Anthrax

Interventions

Biothrax

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Emanuel DeNoia, MD

  ICON plc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 24, 2017
• Study Start: January 18, 2018
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

US (2)