Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons - Full Text View

Sponsor:	Uniformed Services University of the Health Sciences
Collaborators:	Infectious Disease Clinical Research Program National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:	NCT00996970

Purpose

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.

Condition
Influenza H1N1 HIV Vaccine HIV Infections

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons

Resource links provided by NLM:

MedlinePlus related topics: AIDS Flu

U.S. FDA Resources

Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:

To compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To compare the durability of the H1N1 immunologic responses at 6 months post-vaccination between HIV-infected and uninfected persons. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To evaluate the impact of the H1N1 vaccine on CD4 counts/percentages and HIV RNA levels in HIV positive subjects. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To evaluate potential adverse reactions of the H1N1 vaccine in HIV positive versus negative subjects. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood samples will be collected for immunologic studies including antibody titers and cellular responses. Viral isolates will be obtained and characterized among ILI cases during study participation. Blood for CD4/HIV RNA levels will also be obtained among HIV patients to determine the impact of the vaccine on these counts.

Estimated Enrollment:	100
Study Start Date:	October 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Detailed Description:

Our 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 of routine clinical care, with secondary objectives examining the impact of prior seasonal vaccinations on subsequent seroresponse to the novel H1N1 vaccination, determining potential reactions (local or systemic) to this new vaccine among patients, and assessing for potential immunologic/virologic changes (in CD4/HIV RNA levels) after H1N1 vaccination among HIV patients. Finally, we will collect data on influenza-like illnesses (ILI) and H1N1 events during the study follow-up period and influenza isolates causing ILI events will be genetically characterized.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Males and females of all races and all military beneficiaries including active duty enlisted and officers (from all branches of service), retirees, and their dependents presenting for H1N1 vaccination as part of routine clinical care will be eligible for participation. Both HIV-positive and negative persons can participate. Since most of our HIV patients are 18-50 years of age, and seroresponse varies by age, we will enroll persons between the ages of 18-50 years.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996970

Locations

United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20814
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708

Sponsors and Collaborators

Uniformed Services University of the Health Sciences

Infectious Disease Clinical Research Program

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

No publications provided

Responsible Party:	Naval Medical Center San Diego ( LCDR Christopher Duplessis )
Study ID Numbers:	IDCRP-053
Study First Received:	October 15, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00996970 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Uniformed Services University of the Health Sciences:

HIV
H1N1
Influenza

Vaccination
Seroresponse
Immunogenicity

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Orthomyxoviridae Infections
Infection
Immunologic Deficiency Syndromes

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
HIV Infections
Sexually Transmitted Diseases
Influenza, Human
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 30, 2009