CompletedPhase 4

H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients

United States120 participantsStarted 2009-12

Plain-language summary

The overall goal of this study is to study influenza vaccine responses in HIV infected individuals. Immunocompromised individuals require special protection from influenza, but may not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu vaccine as part of their standard of care will be asked to donate blood samples for immunologic studies. These studies will determine whether participants were able to produce the appropriate antibodies to the vaccine and possibly identify predictors of vaccine responsiveness. Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be compromised in HIV infected patients.

Who can participate

Age range

18 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 confirmed diagnosis of HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry or any measurable HIV RNA viral load in the chart. Serum HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
. \> 18 years
. Able to understand and comply with planned study procedures.
. Provides written informed consent prior to initiation of any study procedures.
. Subject should be 1) on stable antiretroviral therapy as outlined in the DHHS treatment guidelines for HIV-1 infected individuals OR 2) not on antiretroviral therapy and not intending to start treatment within the next 30 days.

Exclusion criteria

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

Safety

Timeframe: 21-28 days

Immunogenicity

Timeframe: 21-28 days

Trial details

NCT IDNCT01111162

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-03

Results submitted2016-06-05

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