NasoShield in Healthy Adults to Study Safety and Immunogenicity

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT04415749

Run by

Altimmune, Inc.

People needed

43

Starts

2020-06-15

Expected to finish

2021-03-15

Last updated by the study team

2025-06-24

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

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
• Known allergy to any of the ingredients in the vaccine formulation
• Known allergy or sensitivity to latex
• History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
• Previous nasal surgery or nasal cauterization
• Any symptoms of upper respiratory infection or temperature > 38°C within 3 days before Day 1
• Any symptoms within 24 hours before Day 1 of upper respiratory illness or allergy flare-up that, in the opinion of the Investigator, presents as nasal congestion or rhinorrhea that could inhibit the proper administration of the IP
• Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur
• Immunocompromised individuals, including those who have used corticosteroids(including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period
• History of autoimmune or demyelinating disease
• Use of statin medication within 30 days before Day 1 (see list in Section 6.7.1)

Where it is running

• JBR Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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