Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 0… (NCT01910519) | Clinical Trial Compass
CompletedPhase 2
Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)
United States50 participantsStarted 2013-07
Plain-language summary
This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are approved for use in the United States. The results of this study will help researchers learn about better ways to vaccinate people against the H5N1 flu.
Who can participate
Age range
21 Years – 45 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:
* Individuals in good health (as determined by vital signs, medical history, physical examination and laboratory tests);
* Able to understand and give informed consent;
* Women of childbearing potential must agree to practice adequate contraception 1 month prior to study entry and until day 100 of the study.
Exclusion Criteria:
* Personal or family history of sleeping disorders including any of the following: Narcolepsy with or without cataplexy; Idiopathic Hypersomnia or excessive daytime sleepiness of unknown origin; Sleep paralysis; Sleep related hallucinations (hypnagogic or hypnopompic hallucinations);
* Human leukocyte antigen (HLA)-DQB1\*06:02 positivity (or DQB1\*06 positivity if high resolution HLA testing cannot be performed);
* An abnormal erythrocyte sedimentation rate at baseline;
* Receipt of blood products 3 months prior to study entry and until day 100 of the study;
* Volunteers who donated blood 56 days before screening and have plans to donate on or before day 100 of the study;
* Hemoglobin value of less than 12 mg/dL for females and less than 13 mg/dL for males;
* A positive result in the Narcolepsy Mini Screen questionnaire;
* A score of ≥11 on the Epworth sleepiness scale questionnaire;
* Receipt of any experimental agents within 6 weeks prior to first vaccination and until the completion of the study;
* Receipt of any licensed live vaccine within 4 weeks or any licensed inactivated vaccine within 2 weeks prior to the first study va…
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
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Timeframe: Day 1
2
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Timeframe: Day 3
3
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Timeframe: Day 7
4
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Timeframe: Day 22
5
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Timeframe: Day 24
6
Trial details
NCT IDNCT01910519
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Timeframe: Day 28
7
Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Timeframe: Day 21
8
Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Timeframe: Day 21
9
Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Timeframe: Day 42
10
Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant