Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza VaccinePhase 1NCT01258062
Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults
A Phase 1 study testing GelVac™ nasal powder H5N1 influenza vaccine. in people with Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine, run by Alachua Government Services, Inc. at 1 site in United States.
Trial summary
This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine
- What is being tested?
- GelVac™ nasal powder H5N1 influenza vaccine.
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Apr 2011
- 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
- able to read and sign Informed Consent Form (ICF).
- male or female > 18 and < 49 years of age at the time the ICF is signed.
- generally healthy, as determined by medical history and clinical assessment.
- able to attend all scheduled visits and to comply with all trial procedures.
- if female of child-bearing potential, use of an acceptable method of contraception or abstinence for at least 4 weeks prior to the first vaccination through at least four weeks after the second vaccination. Acceptable methods are hormonal birth control or a barrier method with spermicide.
- if female, post menopausal (no menstrual period within the last 12 months), surgically sterile (hysterectomy or tubal ligation), or have a negative urine pregnancy test within 24 hours prior to the time of vaccination.
Who cannot join
- has a known allergy to fruits (e.g., apples, oranges) or pectin and/or pectin by-products (including jams or jellies).
- has a known allergy to dairy/milk products/lactose.
- is breast-feeding or pregnant or planning on becoming pregnant within 1 month of vaccination.
- has a history of a chronic viral infection (i.e.; Shingles, Herpes Zoster, HIV).
- has a history of severe allergic reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances.
- has a history of demyelinating disease (esp. Guillian-Barre Syndrome).
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- history of Bell's Palsy.
- immunosuppression as a result of underlying illness or treatment.
- use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination.
- use of other immunosuppressive or cytotoxic drugs or radiation therapy within six months prior to vaccination.
- use of OTC or other 'herbal' immune suppressant or stimulants within the 6 months prior to vaccination.
- active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy).
- acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus, and asthma.
- use of experimental vaccines within 6 months prior to study entry, or expected use of experimental vaccines during the entire study period after inoculation with study vaccine.
- participation in another clinical trial 30 days prior to study entry.
- use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period.
- receipt of immunoglobulin or other blood product within 3 months prior to enrollment.
- receipt of other licensed vaccines within the preceding 6 months or expected to receive a licensed vaccine within 28 days following last trial vaccination.
- subject is enrolled in a conflicting clinical trial.
- any disorder or therapy contraindicating influenza vaccination.
- Have a clinically significant structural abnormality of the nasopharynx (e.g., obvious deviation that obstructs airflow in either nostril), as determined by the investigator
- acute respiratory disease at the time of enrollment.
- febrile illness with temperature greater than or equal to 38 degrees Celsius (100.4 degrees F) within 72 hours prior to enrollment.
- receipt of allergy shots within the preceding 7 days or expected to receive allergy shots within 7 days following vaccination.
- any condition that, in the opinion of the investigator, would pose a health risk to the participant.
- presence of any active disease or condition at the administration site that, in the opinion of the Investigator, would impact vaccine delivery or assessment of vaccination site.
- history of drug abuse or alcohol abuse in the five years prior to enrollment. Subject who abuses alcohol or other drugs of abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Research Network, LLC
Gainesville, Florida, 32605
About this study
Official title: Phase 1, Double Blind, Randomized, Placebo Controlled Study to Assess Safety and Immunogenicity of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults.
This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be screened to obtain 7 subjects who will be eligible for study participation.
The primary objective is to determine the frequency and severity of local and systemic adverse events of vaccine.
The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.
- Being tested
- GelVac™ nasal powder H5N1 influenza vaccine., Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelVac™ nasal powder H5N1 influenza vaccine.Drug
subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril
PlaceboDrug
subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril
| Study group | Role | What they receive |
|---|---|---|
| of GelVac™ nasal powder H5N1 influenza vaccine. | Experimental | Not described Receives: Drug: GelVac™ nasal powder H5N1 influenza vaccine. |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to determine the frequency of adverse events of the vaccine.
Measured: up to 26 weeks
Secondary outcomes (1)
The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI.
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza VaccineStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258062
- Sponsor's protocol ID
- 2009-GEL-NT/001
- Status last verified
- Feb 2017
- First submitted
- 6 Dec 2010
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Double Blind, Randomized, Placebo Controlled Study to Assess Safety and Immunogenicity of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults.
- ClinicalTrials.gov ID
- NCT01258062
- Acronym / sponsor ID
- 2009-GEL-NT/001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 10 Dec 2010 (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.
This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be screened to obtain 7 subjects who will be eligible for study participation.
The primary objective is to determine the frequency and severity of local and systemic adverse events of vaccine.
The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| of GelVac™ nasal powder H5N1 influenza vaccine. | Experimental | Drug: GelVac™ nasal powder H5N1 influenza vaccine. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- able to read and sign Informed Consent Form (ICF).
- male or female > 18 and < 49 years of age at the time the ICF is signed.
- generally healthy, as determined by medical history and clinical assessment.
- able to attend all scheduled visits and to comply with all trial procedures.
- if female of child-bearing potential, use of an acceptable method of contraception or abstinence for at least 4 weeks prior to the first vaccination through at least four weeks after the second vaccination. Acceptable methods are hormonal birth control or a barrier method with spermicide.
Key exclusion criteria (27 listed)
- has a known allergy to fruits (e.g., apples, oranges) or pectin and/or pectin by-products (including jams or jellies).
- has a known allergy to dairy/milk products/lactose.
- is breast-feeding or pregnant or planning on becoming pregnant within 1 month of vaccination.
- has a history of a chronic viral infection (i.e.; Shingles, Herpes Zoster, HIV).
- has a history of severe allergic reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances.
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 |
|---|---|---|
| GelVac™ nasal powder H5N1 influenza vaccine.subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril | Drug | of GelVac™ nasal powder H5N1 influenza vaccine. |
| Placebosubjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril | Drug | Placebo |
Primary outcome
The primary objective is to determine the frequency of adverse events of the vaccine.
Time frame: up to 26 weeks
1 secondary outcome
The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI.
Time frame: up to 26 weeks
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 2 Feb 2017.
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 GelVac™ nasal powder H5N1 influenza vaccine. in people with Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine, run by Alachua Government Services, Inc. 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 6 inclusion and 27 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 2 Feb 2017. 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?
The primary objective is to determine the frequency of adverse events of the vaccine. (time frame: up to 26 weeks). 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 2 Feb 2017.