NasoShield Study of Safety and Immunogenicity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2019-05-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

NasoShield in Healthy Adults to Study Safety and Immunogenicity

NCT04415749

Healthy Volunteers

COMPLETED PHASE1

NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)

NCT04442230

Coronavirus Infection

TERMINATED PHASE2

Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)

NCT04679909

Healthy Volunteers

COMPLETED PHASE1

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT05313035

COVID-19

COMPLETED PHASE2/PHASE3

The Safety and Tolerability of A8G6 COVID-19 Neutralization Antibody Combined With Nasal Spray

NCT06127498

SARS-CoV-2 Prevention

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. Subjects will be screened within 28 days of randomization (Day 1). The study is comprised of 2 parts:

* Part A: Approximately 120 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be enrolled into 4 sequential cohorts of 30 subjects each defined by the NasoShield dose (1×108, 1×109, 1×1010, and 1×1011 vp). Within each cohort (and the sentinel group in the first dose cohort), subjects will be randomized in a 4:1:1 ratio to receive 1 intranasal dose of NasoShield (Day 1), 1 intranasal dose of placebo (Day 1), or 3 subcutaneous 0.5 mL doses of BioThrax 14 days apart (Days 1, 15, and 29). NasoShield and placebo will be administered in a double-blind fashion, and BioThrax will be administered in an open-label fashion.
* Part B: Approximately 25 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be randomized in a 4:1 ratio to receive 2 intranasal doses of NasoShield at the highest well tolerated dose from Part A or placebo 21 days apart (Days 1 and 22). NasoShield and placebo will be administered in a double-blind fashion.

Subjects will return to the investigational site for multiple visits through Day 361. At each visit, the subject will be asked about the interim medical history and use of any medications, and safety and immunogenicity assessments will be performed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Double-blind

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NasoShield

NasoShield is an adenovirus-vectored anthrax vaccine.

Intervention Type BIOLOGICAL

BioThrax

Commercially available anthrax vaccine

Intervention Type BIOLOGICAL

Placebo

Normal saline

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Men and women 18 to 49 years of age, inclusive
2. Good general health status as determined by the Investigator
3. Adequate venous access for repeated phlebotomies
4. 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
5. Negative drug and alcohol screen at Screening and predose on Day 1
6. For women who have not been surgically sterilized and do not have laboratory confirmation of postmenopausal status, negative pregnancy test
7. 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
8. Willingness to participate and comply with all aspects of the study through the entire study period, including nasopharyngeal swabs and blood and urine samples
9. Provision of written informed consent

Exclusion Criteria

1. Pregnant, possibly pregnant, or lactating women
2. Household contacts of pregnant women, children \< 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
3. Persons who care for pregnant women, children \< 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
4. Body mass index \> 35.0 kg/m2
5. Positive result for HIV, hepatitis B virus, or hepatitis C virus at Screening
6. 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
7. History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
8. History of coronary artery disease, arrhythmia, or congestive heart failure
9. Clinically significant ECG abnormality as determined by the Investigator
10. Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 95 mmHg) at Screening or predose on Day 1
11. History of anaphylaxis or angioedema
12. Known allergy to any of the ingredients in the vaccine formulation
13. Known allergy or sensitivity to latex
14. History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
15. Previous nasal surgery or nasal cauterization
16. Any symptoms of upper respiratory infection or temperature \> 38°C within 3 days before Day 1
17. 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
18. 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
19. 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
20. Use of statin medication within 30 days before Day 1 (see list in Section 6.8.1)
21. Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1
22. Receipt of any IP within 30 days before Day 1
23. Receipt of any vaccine within 30 days before Day 1
24. Receipt of intranasal vaccine within 90 days before Day 1
25. Receipt of any licensed or investigational anthrax vaccine
26. Any change in medication for a chronic medical condition within 30 days before Day 1
27. Past regular use or current use of intranasal illicit drugs
28. Smokers, including smoking of any type (eg, cigarettes, electronic cigarettes, marijuana). Prior smokers must have quit smoking at least 30 days before Day 1.
29. Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes