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 range18 Years – 50 Years
SexALL
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
What they're measuring
1
To compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons.