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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Infectious Diseases Clinical Research Program

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences

ClinicalTrials.gov Identifier:

NCT00996970

First received: October 15, 2009

Last updated: January 24, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 15, 2009
Last Updated Date	January 24, 2013
Start Date ^ICMJE	October 2009
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 12, 2010)	To compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons. [ Time Frame: interim = 2 months; 6 month f/u = 8 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: October 15, 2009)	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 ]
Change History	Complete list of historical versions of study NCT00996970 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 12, 2010)	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: 2 months ] [ Designated as safety issue: No ] To evaluate potential adverse reactions of the H1N1 vaccine in HIV positive versus negative subjects. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 15, 2009)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
Official Title ^ICMJE	Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA 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.
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.
Condition ^ICMJE	Influenza HIV Infections
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	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;52(1):138-46. Epub 2010 Dec 7.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	132
Estimated Completion Date	December 2014
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00996970
Other Study ID Numbers ^ICMJE	IDCRP-053
Has Data Monitoring Committee	No
Responsible Party	Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences
Study Sponsor ^ICMJE	Uniformed Services University of the Health Sciences
Collaborators ^ICMJE	Infectious Diseases Clinical Research Program National Institute of Allergy and Infectious Diseases (NIAID)
Investigators ^ICMJE	Not Provided
Information Provided By	Uniformed Services University of the Health Sciences
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top