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

Sponsor

Uniformed Services University of the Health Sciences (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT00996970

Collaborator

Infectious Diseases Clinical Research Program (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

132

Enrollment

Locations

158

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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 administration of the H1Nl vaccination is not part of the study's procedures, but is being given as part of routine care.

Condition or Disease	Intervention/Treatment	Phase
Influenza HIV Infections

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 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, the investigators 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.

Study Design

Study Type:

Observational

Actual Enrollment :

132 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

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 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. [1 year]
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]
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]
To compare the durability of the H1N1 immunologic responses at 6 months post-vaccination between HIV-infected and uninfected persons. [1 year]
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]
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]
To evaluate the impact of the H1N1 vaccine on CD4 counts/percentages and HIV RNA levels in HIV positive subjects. [2 months]
To evaluate potential adverse reactions of the H1N1 vaccine in HIV positive versus negative subjects. [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
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