Influenza A Subtype H5N1 InfectionPhase 1NCT00755703
Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
A Phase 1 study testing Pandemic Influenza Vaccine in people with Influenza A Subtype H5N1 Infection, run by Altimmune, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies. Read more about this study
- Who is it for?
- Ages 19 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Subtype H5N1 Infection
- What is being tested?
- Pandemic Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 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 19 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females in good general health, 19-49 years of age
- Subjects must provide written consent
- Willing to participate through study completion
- Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis
- Female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception.
- Meet screening criteria for hematology, chemistry and urinalysis
Who cannot join
- Pregnant (or possibly pregnant) and lactating women
- Any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment
- Any intranasal steroid medication administered in the 10 days prior to study enrollment
- History of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities
- Any previous nasal cautery or significant surgery for nasal septal defects
- Any regular past or current use of intranasal illicit drugs or history of intravenous illicit drug use
Show all 18Show fewer
- Asthma that is greater than mild in severity
- Diagnosed active Hepatitis B or C
- HIV positive at screening
- Known or suspected malignancy, leukemia, or lymphoma
- Immunosuppressed, altered or compromised immune status as a consequence of disease or treatment with systemic corticosteroids
- Receipt of an influenza vaccine within the past 6 months
- Receipt of any vaccine in the past 30 days
- Receipt of any investigational drug in the past 30 days
- Known Diabetes mellitus
- History of anaphylaxis or angioedema
- Hypertension that is not well controlled
- Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator would serve to interfere or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participants's ability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Alabama Vaccine Research Center (UAB)
Birmingham, Alabama, 35294-2050
About this study
Official title: A Phase I, Dose-Ranging Safety and Immunogenicity Study of an Adenovirus-vectored Intranasal, Pandemic (Hemagglutinin H5) Influenza Vaccine, ADhVN1203/04.H5, in Healthy Adults
The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies.
The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.
Read the detailed description
Objectives:
The primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.
The secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.
- Conditions
- Influenza A Subtype H5N1 Infection
- Being tested
- Pandemic Influenza Vaccine, Placebo
- Keywords
- Influenza, Vaccine, Pandemic, Avian influenza, Adenovirus strain 5, Vectored vaccine, Intranasal, Tissue-culture derived, Non-replicating
- Medical subject headings
- Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pandemic Influenza VaccineBiological
Undetermined
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | There will be 12 subjects in Group 1 that will receive 10e8 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). Receives: Biological: Pandemic Influenza Vaccine |
| Group 2 | Experimental | There will be 12 subjects in Group 2 that will receive 10e9 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). Receives: Biological: Pandemic Influenza Vaccine |
| Group 3 | Experimental | There will be 12 subjects in Group 3 that will receive 10e10 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). Receives: Biological: Pandemic Influenza Vaccine |
| Experimental: Group 4 | Placebo comparator | There will be 12 subjects in Group 4 that will receive a placebo consisting of buffer administered via intranasal spray on day 0 and day 28 (+/- 4d). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
Measured: 56 day observations with 2 year follow-up
Secondary outcomes (1)
Determination of immunogenicity and correlates of protection based on HI titers in vaccinates
Measured: 28 days and 56 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A Subtype H5N1 InfectionStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott D. Parker, M.D., Principal investigator, Alabama Vaccine Research Clinic, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755703
- Sponsor's protocol ID
- H-0701-2
- Other IDs
- #1-UCI-AI-06205-01
- Status last verified
- May 2025
- First submitted
- 17 Sep 2008
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose-Ranging Safety and Immunogenicity Study of an Adenovirus-vectored Intranasal, Pandemic (Hemagglutinin H5) Influenza Vaccine, ADhVN1203/04.H5, in Healthy Adults
- ClinicalTrials.gov ID
- NCT00755703
- Acronym / sponsor ID
- H-0701-2
- Conditions
- Influenza A Subtype H5N1 Infection
- Keywords
- Influenza, Vaccine, Pandemic, Avian influenza, Adenovirus strain 5, Vectored vaccine, Intranasal, Tissue-culture derived
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Sep 2008 (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 recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies.
The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.
Detailed description
Objectives:
The primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.
The secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Pandemic Influenza VaccineThere will be 12 subjects in Group 1 that will receive 10e8 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Group 2 | Experimental | Biological: Pandemic Influenza VaccineThere will be 12 subjects in Group 2 that will receive 10e9 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Group 3 | Experimental | Biological: Pandemic Influenza VaccineThere will be 12 subjects in Group 3 that will receive 10e10 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Experimental: Group 4 | Placebo comparator | Biological: PlaceboThere will be 12 subjects in Group 4 that will receive a placebo consisting of buffer administered via intranasal spray on day 0 and day 28 (+/- 4d). |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males and females in good general health, 19-49 years of age
- Subjects must provide written consent
- Willing to participate through study completion
- Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis
- Female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception.
Key exclusion criteria (18 listed)
- Pregnant (or possibly pregnant) and lactating women
- Any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment
- Any intranasal steroid medication administered in the 10 days prior to study enrollment
- History of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities
- Any previous nasal cautery or significant surgery for nasal septal defects
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 |
|---|---|---|
| Pandemic Influenza VaccineUndetermined | Biological | Group 1, Group 2, Group 3 |
| Placebo | Biological | Experimental: Group 4 |
Primary outcome
To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
Time frame: 56 day observations with 2 year follow-up
1 secondary outcome
Determination of immunogenicity and correlates of protection based on HI titers in vaccinates
Time frame: 28 days and 56 days post vaccination
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 29 May 2025.
Related trials for Influenza A Subtype H5N1 Infection
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Avian Influenza A Virus
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.
Scott D. Parker, M.D. principal investigator
Alabama Vaccine Research Clinic, University of Alabama at Birmingham
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 Pandemic Influenza Vaccine in people with Influenza A Subtype H5N1 Infection, run by Altimmune, 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 18 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 29 May 2025. 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?
To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults. (time frame: 56 day observations with 2 year follow-up). 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 29 May 2025.