Clinical trial NCT00996970: Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
Official title: Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
HIV Infections
Keywords: HIV
H1N1
Influenza
Vaccination
Seroresponse
Immunogenicity
Vaccine
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Clinical Research Program
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-10-16
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: To compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons.
timeFrame: interim = 2 months; 6 month f/u = 8 months
Secondary outcomes:
measure: 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.
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: To compare the durability of the H1N1 immunologic responses at 6 months post-vaccination between HIV-infected and uninfected persons.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: To evaluate the impact of the H1N1 vaccine on CD4 counts/percentages and HIV RNA levels in HIV positive subjects.
timeFrame: 2 months
measure: To evaluate potential adverse reactions of the H1N1 vaccine in HIV positive versus negative subjects.
timeFrame: 2 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
References:
citation: Crum-Cianflone NF, Eberly LE, Duplessis C, Maguire J, Ganesan A, Faix D, Defang G, Bai Y, Iverson E, Lalani T, Whitman T, Blair PJ, Brandt C, Macalino G, Burgess T. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in an immunocompromised population: a prospective study comparing HIV-infected adults with HIV-uninfected adults. Clin Infect Dis. 2011 Jan 1;52(1):138-46. doi: 10.1093/cid/ciq019. Epub 2010 Dec 7.