AzTrials
AzTrials

Healthy Adult VolunteersPhase 1NCT01354379

Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Administered by Sprayer

A Phase 1 study testing NB-1008 and Fluzone IN in people with Healthy Adult Volunteers, run by NanoBio Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adult Volunteers
What is being tested?
NB-1008 and Fluzone IN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteUnited States
Study dates
May 2011to Jul 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 22010-2011 influenza vaccine or the 2009 pandemic H1N1 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.
Show all 22Show fewer
  • 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)].
  • History of drug or chemical abuse in the year before the study.
  • Receipt of any investigational product or nonregistered drug within the 30 days before study entry or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing 6 month period.
  • Use of nasally administered prescription or over-the-counter (OTC) medications within 7 days before vaccination
  • Receipt of blood or blood products 8 weeks before study entry or planned administration prior to the Day 60 telephone contact.
  • Donation of blood or blood products within 8 weeks before study entry or at any time up to the Day 28 clinic visit.
  • Acute disease within a week prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination) with or without fever. For subjects with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade febrile illness, the subject can be re-screened once they have complexly recovered.
  • Any condition that, in the opinion of the investigator, might interfere with study objectives.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: A Phase 1 Randomized, Observer-Blind, Controlled, Safety, Tolerability and Immunogenicity Study of Intranasal NB-1008 in Healthy Adult Volunteers Administered by Nasal Sprayer and Pipette

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. In a prior clinical study this vaccine showed promising results in terms of being well tolerated and eliciting mucosal and systemic immune responses after administration by a dropper. In this study NB-1008 is being administered by dropper as well as a nasal sprayer to determine if the sprayer further enhances the immune response.

Being tested
NB-1008, Fluzone IN

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NB-1008Biological

    NB-1008 is composed of Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA) and 20% W805EC adjuvant.

  • Fluzone INBiological

    The active control is Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA).

Study groups in NCT01354379
Study groupRoleWhat they receive
Fluzone 15 mcg HA 200 mcl IN by PipetteActive comparatorNot described
Receives: Biological: Fluzone IN
NB-1008 15 mcg HA 20% W805EC 200 mcl IN by PipetteExperimentalNot described
Receives: Biological: NB-1008
Fluzone 15 mcg HA 200 mcl IN by Nasal SprayActive comparatorNot described
Receives: Biological: Fluzone IN
NB-1008 15 mcg HA 20% W805EC 200 mcl IN by Nasal SprayExperimentalNot described
Receives: Biological: NB-1008
NB-1008 15 mcg HA 20% W805EC 400 mcl IN by Nasal SprayExperimentalNot described
Receives: Biological: NB-1008

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

    Number of Participants with Adverse Events (AE) collected through Day 28 and Serious Adverse Events (SAE) collected through Day 365.

    Measured: 365 Days

Secondary outcomes (3)

  1. Systemic Humoral Immune Response

    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

    Measured: Day 28 and Day 60

  2. Systemic Cell Mediated Immune Response

    Stimulation Index (SI) of antigen-specific proliferation and cytokine secretion of peripheral mononuclear cells (PBMC)

    Measured: Day 28

  3. Mucosal Immune Response

    Nasal wash anti-Fluzone IgA Geometric Mean Titer (GMT) and proportion of volunteers with >=4 fold increase in GMT anti-Fluuzone IgA titer

    Measured: Day 14 and Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJun 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01354379
Sponsor's protocol ID
NB-1008-002
Status last verified
Mar 2013
First submitted
13 May 2011
Last updated
28 Mar 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NB-1008 and Fluzone IN in people with Healthy Adult Volunteers, run by NanoBio Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: 365 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01354379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in