Status:
COMPLETED
Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
HIV Infections
Eligibility:
All Genders
18-50 years
Brief 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 administrati...
Detailed Description
The investigators study is being conducted to evaluate and compare the seroresponses of the novel H1N1 vaccination among HIV positive and negative persons receiving the novel H1N1 vaccination as part ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00996970
Start Date
October 1 2009
End Date
December 1 2022
Last Update
March 22 2023
Active Locations (3)
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1
Naval Medical Center San Diego
San Diego, California, United States, 92134
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
3
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708