Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons (NCT00996970) | Clinical Trial Compass
CompletedNot Applicable
Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
United States132 participantsStarted 2009-10
Plain-language summary
The purpose of this research is to determine the effectiveness of the novel H1Nl influenza (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons. The administration of the H1Nl vaccination is not part of the study's procedures, but is being given as part of routine care.
Who can participate
Age range
18 Years – 50 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:
* 18-50 years of age
* Receiving the novel H1N1 vaccine (killed formulation) as part of routine clinical care
* A military beneficiary who expects to remain in the local area for the next 6 months
Exclusion Criteria:
* Healthcare worker who is involved in direct patient care
* Acute febrile illnesses within 30 days prior to H1N1 vaccination (e.g., pneumonia, influenza, ILI)
* Diabetes type 1 or type 2
* Systemic steroid or immunosuppressive medication use within 4 weeks of vaccination
* Active diagnoses of a cancer (non-melanoma skin cancer allowed).
* History of organ transplant
* Chronic active hepatitis B or C
* Active illicit drug use or alcohol abuse
* Blood transfusion within the last year
* Allergy to eggs
* Previous significant adverse reaction (e.g., anaphylaxis) to the seasonal influenza vaccination
* History of serious reactions to any prior vaccination (e.g., Guillain Barre Syndrome (GBS)).
* Received another vaccination in the last 4 weeks (receipt of seasonal influenza vaccination is allowed)
* Among females of childbearing potential, pregnant or within 6 weeks of being postpartum
* History of ILI which was confirmed as an H1N1 infection
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 compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons.