An Open-Label, Randomized Phase I Study in Healthy Adults of the Safety and Immunogenicity of Pri… (NCT01086657) | Clinical Trial Compass
CompletedPhase 1
An Open-Label, Randomized Phase I Study in Healthy Adults of the Safety and Immunogenicity of Prime-Boost Intervals With Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc.) Administered Alone or Following Re...
United States64 participantsStarted 2010-02-25
Plain-language summary
Background:
\- New vaccines against avian influenza, also known as "bird flu," are being developed and require testing to determine if they are safe and effective and whether they have any side effects. Researchers are interested in testing two experimental avian influenza vaccines to see whether they are safe, if there are any side effects from the vaccines, and how the body's immune response differs in response to different vaccination schedules. One vaccine is an inactivated vaccine (made with killed or weakened influenza) and one is a DNA vaccine that allows the body to use vaccine to make an immune system response to a specific part of an avian influenza protein.
Objectives:
* To determine the safety and potential side effects of two experimental vaccines against avian influenza.
* To evaluate whether the time between the two experimental vaccine injections affects the immune response to the vaccine.
Eligibility:
\- Healthy individuals between 18 and 60 years of age.
Design:
* Participants will be randomly divided (by chance) into six groups to receive two injections of vaccine at different intervals. One group will receive only the inactivated vaccine, while the other groups will receive the DNA vaccine followed by the inactivated vaccine at different intervals (e.g., 4 weeks, 8 weeks, 12 weeks, 16 weeks or 24 weeks later).
* Participants will remain at the clinical center for at least 30 minutes after each vaccination. A few days after each injection, participants will contact staff by telephone or have a clinic visit. Participants will also be asked to complete a diary card at home for 5 days to keep track of temperature changes, injection site skin changes, and other effects.
* Four weeks after the first injection, participants will return for a clinic visit and to provide blood samples for testing.
* Two weeks after the second injection, participants will return for a clinic visit and provide blood samples (collected through apheresis) to provide information on immune response to the vaccine.
Who can participate
Age range
18 Years – 60 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:
A subject must meet all of the following criteria:
18 to 60 years old.
Available for clinical follow-up for up to 32 weeks after enrollment.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Complete an Assessment of Understanding (AoU) questionnaire prior to enrollment and verbalize understanding of all questions answered incorrectly.
Able and willing to complete the informed consent process.
Willing to donate blood for sample storage to be used for future research.
In good general health without clinically significant medical history.
Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) \< 40 within the 56 days prior to enrollment.
Laboratory Criteria within 56 days prior to enrollment:
Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to13.5 g/dL for men
White blood cells (WBC) = 3,300-12,000 cells/mm(3)
Differential either within institutional normal range or accompanied by site physician approval
Total lymphocyte count greater than or equal to 800 cells/mm3
Platelets = 125,000 - 500,000/mm(3)
Alanine aminotransferase (ALT) \< 1.25 x upper limit of normal (ULN)
Serum creatinine less than or equal to 1 x ULN (less than or equal to1.3 mg/dL for females; less than or equal to1.4 mg/dL for males)
Negative FDA-approved HIV blood test. \[Note: Results of HIV enzyme-linked immunosorbent assay…
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
Safety: adverse events, including clinical, laboratory and local and systemic reactogenicity
Trial details
NCT IDNCT01086657
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)