Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine. (NCT00755703) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
United States48 participantsStarted 2008-10
Plain-language 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.
The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.
Who can participate
Age range
19 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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 investigatio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
Timeframe: 56 day observations with 2 year follow-up