NasoShield in Healthy Adults to Study Safety and Immunogenicity

NCT04415749 | Completed Phase 1 FDA Drug

• 2 other identifiers: ALT-201-102HHSO100201600008C
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Anthrax

Outcome Measures

Primary Outcomes (2)

• Reactogenicity to evaluate the safety of NasoShield

  Subjects will record solicited local and systemic events for 7 days after each dose

  For 7 days after vaccination

• Adverse Events (AEs) to evaluate the safety of NasoShield

  All adverse events from Day 1 to Day 57; serious adverse events (SAE), medically attended adverse events (MAAE), and new-onset chronic illnesses (NCI) from Day 1 to Day 210

  From Day 1 to Day 210

Secondary Outcomes (3)

• Anti-protective antigen (PA) immunoglobulin G (IgG) to evaluate humoral immunogenicity

  From Day 1 to Day 210

• Toxin neutralization antibody 50% neutralization factor (TNA-NF50) titer measured in serum by cytotoxic assay to evaluate humoral immunogenicity

  From Day 1 to Day 210

• Anti-protective antigen (PA) immunoglobulin A (IgA) to evaluate mucosal immune response

  From Day 1 to Day 57

Study Arms (6)

NasoShield One Dose in Position 1

EXPERIMENTAL

NasoShield (1 x 10\^11 vp) on Day 1 and saline placebo on Day 29 in position 1 (Group 1) in normal sitting position (no dose holding time)

Biological: NasoShield; Other: Placebo

Placebo in Position 1

PLACEBO COMPARATOR

Saline placebo on Day 1 and saline placebo on Day 29 in position 1 (Group 1)

Other: Placebo

NasoShield Two Doses in Position 2

EXPERIMENTAL

NasoShield (1 x 10\^11 vp) on Day 1 and Day 29 in position 2 (Group 2) in sitting position with nostrils elevated above head for 3 minutes followed by sitting for 27 minutes

Biological: NasoShield

Placebo in Position 2

PLACEBO COMPARATOR

Saline placebo on Day 1 and Day 29 in position 2 (Group 2)

Other: Placebo

NasoShield Two Doses in Position 3

EXPERIMENTAL

NasoShield (1 x 10\^11 vp) on Day 1 and Day 29 in position 3 (Group 3) in supine position for 30 minutes

Biological: NasoShield

Placebo in Position 3

PLACEBO COMPARATOR

Saline placebo on Day 1 and Day 29 in position 3 (Group 3)

Other: Placebo

Interventions

NasoShield BIOLOGICAL

NasoShield is an adenovirus-vectored anthrax vaccine

NasoShield One Dose in Position 1; NasoShield Two Doses in Position 2; NasoShield Two Doses in Position 3

Placebo OTHER

Normal saline

NasoShield One Dose in Position 1; Placebo in Position 1; Placebo in Position 2; Placebo in Position 3

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
• 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 or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test
• Willingness to practice a highly effective method of contraception that may include, but is not limited to, 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
• 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
• Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 95 mmHg) at Screening or predose on Day 1
• History of anaphylaxis or angioedema

Sponsors & Collaborators

• Altimmune, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Anthrax

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: 3 parallel groups defined by dosing position and number of doses

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 15, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)