Healthy Adult VolunteersPhase 1NCT01333462
Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008
A Phase 1 study testing NB-1008 in people with Healthy Adult Volunteers, run by NanoBio Corporation at 1 site in United States.
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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2010
- 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 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.
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- 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.
About this study
Official title: A Phase 1 Randomized, Single-Blind, Controlled, Safety, Tolerability and Immunogenicity Study of Intranasal NB-1008 (Fluzone® + 60%W805EC) in Healthy Adult Volunteers
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.
- Conditions
- Healthy Adult Volunteers
- Being tested
- NB-1008, Control
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 4 micrograms (mcg) or 10 micrograms of strain-specific hemagglutinin (HA) and 5%, 10%, 15%, or 20% W805EC adjuvant.
ControlOther
The controls include PBS placebo control as well as Fluzone IN and IM active controls.
| Study group | Role | What they receive |
|---|---|---|
| Phosphate Buffered Saline (PBS) IN | Placebo comparator | Not described Receives: Other: Control |
| Fluzone 4 mcg HA IN | Active comparator | Not described Receives: Other: Control |
| Fluzone 15 mcg HA IM | Active comparator | Not described Receives: Other: Control |
| NB-1008 4 mcg HA 5% W805EC | Experimental | Not described Receives: Biological: NB-1008 |
| NB-1008 4 mcg HA 10% W805EC | Experimental | Not described Receives: Biological: NB-1008 |
| NB-1008 4 mcg HA 15% W805EC | Experimental | Not described Receives: Biological: NB-1008 |
| NB-1008 4 mcg HA 20% W805EC | Experimental | Not described Receives: Biological: NB-1008 |
| Fluzone 10 mcg HA IN | Active comparator | Not described Receives: Other: Control |
| NB-1008 10 mcg HA 5% W805EC | Experimental | Not described Receives: Biological: NB-1008 |
| NB-1008 10 mcg HA 10% W805EC | Experimental | Not described Receives: Biological: NB-1008 |
| NB-1008 10 mcg HA 15% W805EC | Experimental | Not described Receives: Biological: NB-1008 |
| NB-1008 10 mcg HA 20% W805EC | Experimental | Not described Receives: Biological: NB-1008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Adverse events (AE) collected through Day 28 and Serious Adverse Events (SAE) collected through Day 365.
Measured: 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
HAI antibody titers to H1N1, H3N2, and B influenza strains contained in the vaccine.
Measured: 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
Nasal Wash IgA to Fluzone.
Measured: Day 28 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoBio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333462
- Sponsor's protocol ID
- NB-1008-001
- Status last verified
- Apr 2011
- First submitted
- 5 Apr 2011
- Last updated
- 12 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Single-Blind, Controlled, Safety, Tolerability and Immunogenicity Study of Intranasal NB-1008 (Fluzone® + 60%W805EC) in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01333462
- Acronym / sponsor ID
- NB-1008-001
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- NanoBio CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Phosphate Buffered Saline (PBS) IN | Placebo comparator | Other: Control |
| Fluzone 4 mcg HA IN | Active comparator | Other: Control |
| Fluzone 15 mcg HA IM | Active comparator | Other: Control |
| NB-1008 4 mcg HA 5% W805EC | Experimental | Biological: NB-1008 |
| NB-1008 4 mcg HA 10% W805EC | Experimental | Biological: NB-1008 |
| NB-1008 4 mcg HA 15% W805EC | Experimental | Biological: NB-1008 |
| NB-1008 4 mcg HA 20% W805EC | Experimental | Biological: NB-1008 |
| Fluzone 10 mcg HA IN | Active comparator | Other: Control |
| NB-1008 10 mcg HA 5% W805EC | Experimental | Biological: NB-1008 |
| NB-1008 10 mcg HA 10% W805EC | Experimental | Biological: NB-1008 |
| NB-1008 10 mcg HA 15% W805EC | Experimental | Biological: NB-1008 |
| NB-1008 10 mcg HA 20% W805EC | Experimental | Biological: NB-1008 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NB-1008NB-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. | Biological | NB-1008 10 mcg HA 10% W805EC, NB-1008 10 mcg HA 15% W805EC, NB-1008 10 mcg HA 20% W805EC, NB-1008 10 mcg HA 5% W805EC, NB-1008 4 mcg HA 10% W805EC, NB-1008 4 mcg HA 15% W805EC, NB-1008 4 mcg HA 20% W805EC, NB-1008 4 mcg HA 5% W805EC |
| ControlThe controls include PBS placebo control as well as Fluzone IN and IM active controls. | Other | Fluzone 10 mcg HA IN, Fluzone 15 mcg HA IM, Fluzone 4 mcg HA IN, Phosphate Buffered Saline (PBS) IN |
Primary outcome
Number of Participants with Adverse Events
Time frame: 365 Days
Adverse events (AE) collected through Day 28 and Serious Adverse Events (SAE) collected through Day 365.
2 secondary outcomes
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
Time frame: 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
Time frame: Day 28 and Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NB-1008 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 12 Apr 2011. 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. Some participants in this study may receive a placebo. 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?
Number of Participants with Adverse Events (time frame: 365 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2011.