Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008
A Phase 1 Randomized, Single-Blind, Controlled, Safety, Tolerability and Immunogenicity Study of Intranasal NB-1008 (Fluzone® + 60%W805EC) in Healthy Adult Volunteers
1 other identifier
interventional
199
1 country
1
Brief Summary
The purpose of this study is to test the safety and immune response of a new intranasal vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine that is normally given as an injection, called Fluzone, and an adjuvant (additive that helps a vaccine work better), called W805EC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 5, 2011
CompletedFirst Posted
Study publicly available on registry
April 12, 2011
CompletedApril 12, 2011
April 1, 2011
5 months
April 5, 2011
April 11, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events
Adverse events (AE) collected through Day 28 and Serious Adverse Events (SAE) collected through Day 365.
365 Days
Secondary Outcomes (2)
Serum hemagglutination-inhibition (HAI) Geometric Mean Titer (GMT) and proportion of Volunteers with >=4 fold increase in titer as well as proportion of volunteers with titer >= protective level of 40
Day 28 and Day 60
Nasal wash anti-Fluzone IgA Geometric Mean Titer (GMT) and proportion of volunteers with >=4 fold increase in GMT anti-Fluuzone IgA titer
Day 28 and Day 60
Study Arms (12)
Phosphate Buffered Saline (PBS) IN
PLACEBO COMPARATORFluzone 4 mcg HA IN
ACTIVE COMPARATORFluzone 15 mcg HA IM
ACTIVE COMPARATORNB-1008 4 mcg HA 5% W805EC
EXPERIMENTALNB-1008 4 mcg HA 10% W805EC
EXPERIMENTALNB-1008 4 mcg HA 15% W805EC
EXPERIMENTALNB-1008 4 mcg HA 20% W805EC
EXPERIMENTALFluzone 10 mcg HA IN
ACTIVE COMPARATORNB-1008 10 mcg HA 5% W805EC
EXPERIMENTALNB-1008 10 mcg HA 10% W805EC
EXPERIMENTALNB-1008 10 mcg HA 15% W805EC
EXPERIMENTALNB-1008 10 mcg HA 20% W805EC
EXPERIMENTALInterventions
NB-1008 is composed of Fluzone containing 4 micrograms (mcg) or 10 micrograms of strain-specific hemagglutinin (HA) and 5%, 10%, 15%, or 20% W805EC adjuvant.
The controls include PBS placebo control as well as Fluzone IN and IM active controls.
Eligibility Criteria
You may qualify if:
- Male or female.
- Are 18-49 years of age, inclusive.
- If female, must be non-pregnant as confirmed by a negative serum pregnancy test conducted at screening and a negative urine pregnancy test conducted at the site within 24 hours preceding receipt of vaccine.
- Females who are not surgically sterile or at least one year post-menopausal agree to use oral, implantable, transdermal or injectable contraceptive or another reliable form of contraception approved by the Investigator for a minimum of 30 days prior to vaccination and for 3 months following vaccination.
- Healthy, as determined by medical history, physical examination, vital signs, and clinical laboratory examinations.
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
- Has given written informed consent to participate in the study.
You may not qualify if:
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness (institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months). Subjects with a history of chronic cough, frequent sinus infections, sinusitis, allergic rhinitis, nasal polyps or obstruction, including deviated septum significant enough to obstruct the nasal openings are to be excluded. Subjects with seasonal rhinitis may be included if their 'season' does not occur within 3 months of the vaccination date and they are not currently receiving intranasal steroids.
- Receipt of the 2008-2009 influenza vaccine.
- Positive serology for HIV-1 or HIV-2, or HCV antibodies.
- Platelet count \<150,000/mm3.
- Positive urine drug screen.
- History of aspiration, dysphagia, swallowing disorders, stroke or other neurologic conditions that may predispose the subject to aspiration of test articles into the respiratory tract.
- History of Bell's palsy.
- Cancer or treatment for cancer, within 3 years. Subjects with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Basal cell carcinoma (BCC) or (SCC) are allowed, unless present on or near the nose.
- Impaired immune responsiveness, regardless of cause, including diabetes mellitus.
- Presently receiving or history of receiving any medications or treatments that affects the immune system such as immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months.
- Chronic use of inhaled or intranasal sprays including decongestants and corticosteroids.
- Presently a smoker or tobacco user or have a history of smoking or tobacco use within the past year prior to screening.
- Receipt or planned administration of a nonstudy vaccine within 30 days before the study, including licensed influenza vaccines and prior to the Day 60 telephone contact. Immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) up to 8 days before or at least 8 days after a dose of study vaccine will be allowed. Administration of study vaccine can be delayed if a nonstudy vaccine has been administered and will be given as soon as acceptable, as described above.
- Known allergy to any vaccine component, including eggs, egg products, or thimerosal.
- History of allergic and/or anaphylactic type reaction to injected vaccines or to any of the components of NB-1008 \[soybean oil, dehydrated alcohol (anhydrous ethanol), polysorbate (Tween 80) and cetylpyridinium chloride (CPC)\].
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 5, 2011
First Posted
April 12, 2011
Study Start
March 1, 2009
Primary Completion
August 1, 2009
Study Completion
September 1, 2010
Last Updated
April 12, 2011
Record last verified: 2011-04