HIV Infections Clinical Trial
Official title:
Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
NCT number | NCT00996970 |
Other study ID # | IDCRP-053 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2009 |
Est. completion date | December 2022 |
Verified date | March 2023 |
Source | Henry M. Jackson Foundation for the Advancement of Military Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 132 |
Est. completion date | December 2022 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Naval Medical Center Portsmouth | Portsmouth | Virginia |
United States | Naval Medical Center San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Henry M. Jackson Foundation for the Advancement of Military Medicine | Infectious Diseases Clinical Research Program, National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons. | interim = 2 months; 6 month f/u = 8 months | ||
Secondary | To compare the immunogenicity via HAI titer levels, microneutralization seroresponses and titer levels, and cellular responses following H1N1 vaccination between HIV positive and negative persons. | 1 year | ||
Secondary | Among those undergoing vaccination with the seasonal influenza vaccine during the current influenza season, to compare the presence of a positive seroresponse between HIV positive and negative persons | 1 year | ||
Secondary | To evaluate the effect of pre-existing anti-influenza immunity and recent history of seasonal influenza vaccination on seroresponses to the H1N1 influenza vaccine among both HIV positive and negative persons. | 1 year | ||
Secondary | To compare the durability of the H1N1 immunologic responses at 6 months post-vaccination between HIV-infected and uninfected persons. | 1 year | ||
Secondary | To evaluate the number of ILIs and documented influenza cases among HIV-infected and uninfected persons after initial vaccination, and to genetically characterize the influenza strains causing ILI events in our study cohort. | 1 year | ||
Secondary | To evaluate the impact of CD4 counts/percentages, HIV RNA levels, and HAART use on the immunologic responses to H1N1 vaccination in HIV positive subjects. | 1 year | ||
Secondary | To evaluate the impact of the H1N1 vaccine on CD4 counts/percentages and HIV RNA levels in HIV positive subjects. | 2 months | ||
Secondary | To evaluate potential adverse reactions of the H1N1 vaccine in HIV positive versus negative subjects. | 2 months |
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