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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996970
First Posted: October 16, 2009
Last Update Posted: December 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences
  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 HIV Infections

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

Resource links provided by NLM:


Further study details as provided by Timothy Burgess, MD, MPH, 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: 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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 1 year ]
  • To compare the durability of the H1N1 immunologic responses at 6 months post-vaccination between HIV-infected and uninfected persons. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 1 year ]
  • To evaluate the impact of the H1N1 vaccine on CD4 counts/percentages and HIV RNA levels in HIV positive subjects. [ Time Frame: 2 months ]
  • To evaluate potential adverse reactions of the H1N1 vaccine in HIV positive versus negative subjects. [ Time Frame: 2 months ]

Biospecimen Retention:   Samples Without DNA
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.

Enrollment: 132
Study Start Date: October 2009
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996970


Locations
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Timothy Burgess, MD, MPH, Program Director, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT00996970     History of Changes
Other Study ID Numbers: IDCRP-053
First Submitted: October 15, 2009
First Posted: October 16, 2009
Last Update Posted: December 23, 2016
Last Verified: December 2016

Keywords provided by Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences:
HIV
H1N1
Influenza
Vaccination
Seroresponse
Immunogenicity
Vaccine

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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