Status:
COMPLETED
Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX
Lead Sponsor:
Altimmune, Inc.
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE2
Brief Summary
This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be screened within 28...
Detailed Description
This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be screened within 28...
Eligibility Criteria
Inclusion
- Subjects who meet all of the following criteria may be included in the study:
- 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 elevation 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 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, or 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 NasoVAX/placebo 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
- Subjects who meet any of the following criteria will be excluded from the study:
- 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 results 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 the 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
- 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
- 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 of 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
- Use of statin medication within 30 days before Day 1 (see list in Section 6.8.1)
- Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1
- Receipt of any investigational product (IP) within 30 days before Day 1
- Receipt of any vaccine within 30 days before Day 1
- Receipt of intranasal vaccine within 90 days before Day 1
- Receipt of any influenza vaccine within 6 months before Day 1
- Any change in medication for a chronic medical condition within 30 days before Day 1
- Past regular use or current use of intranasal illicit drugs
- Smoking of any type (eg, cigarettes, electronic cigarettes, marijuana) or use of any tobacco product within 30 days before Day 1
- 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
Exclusion
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03232567
Start Date
September 18 2017
End Date
June 15 2018
Last Update
April 30 2024
Active Locations (1)
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1
Optimal Health Research
Rockville, Maryland, United States, 20850