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Immune Response to Influenza Vaccine in HIV-Infected Individuals

Primary Purpose

HIV Infections

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Immunization, Immune Activation, Flu, Antibodies, Titers, HIV, Healthy Volunteer, HV

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: HIV Positive: Age greater than or equal 18 but less than or equal to 60 years old and willing and able to give informed consent Enrollment during the USA influenza season (October-March) Self-reported history of HIV infection at enrollment (If NIH HIV testing does not confirm that the subject is HIV-positive, the subject will be discontinued from the study and not included in the analysis.) HIV Negative: Age greater than or equal to 18 but less than or equal to 60 years old and willing and able to give informed consent Enrollment during USA influenza season (October-March) Self-reported healthy HIV-negative (If NIH HIV testing does not confirm that the subject is HIV-negative, the subject will be discontinued from the study and not included in the analysis.) EXCLUSION CRITERIA: HIV Positive: Self-reported history of vaccination with the trivalent influenza preparation used for the current influenza season Self-reported vaccination with any vaccine within the one month period prior to study enrollment Acute febrile illness (may defer vaccine until resolved) History of hypersensitivity to any influenza vaccine components including thimerosal or egg History of Guillain-Barre syndrome Intention to receive any other vaccine during the study period Pregnancy Self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins, corticosteroids, or G(M)-CSF in the 4 weeks prior to enrollment Self-reported history of IL-2 administration within the past 5 years Use of theophylline preparations or warfarin because of the theoretical possibilities, of enhanced drug effects and toxicities post influenza vaccination Active infection or other serious illness other than HIV that might affect the immune response to a vaccine Current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with patient compliance and ability to make study visits HIV Negative: Self-reported history of vaccination with the trivalent influenza preparation used for the current influenza season Self-reported vaccination with any vaccine within the one month period prior to study enrollment Acute febrile illness (may defer vaccine until resolved) History of hypersensitivity to any influenza vaccine components including thimerosal or egg History of Guillain-Barre syndrome Intention to receive any other vaccine during the study period Pregnancy Self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins, corticosteroids, or G(M)-CSF in the 4 weeks prior to enrollment Use of theophylline preparations or warfarin because of the theoretical possibilities, of enhanced drug effects and toxicities post influenza vaccination Any medical conditions, or medication use might affect the immune response to a vaccine Current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with patient compliance and ability to make study visit

Sites / Locations

  • National Institute of Allergy and Infectious Diseases (NIAID)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 2, 2003
Last Updated
March 3, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00069914
Brief Title
Immune Response to Influenza Vaccine in HIV-Infected Individuals
Official Title
Immune Response to Influenza Vaccination in HIV-Infected Individuals
Study Type
Observational

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
This study will evaluate how HIV infection, including CD4 cell count and viral load, affects the patient's ability to produce antibodies in response to vaccination with the influenza (flu) vaccine. Earlier studies have shown that people with HIV infection do not respond as well as healthy subjects to flu vaccine; that is, they don't make as many antibodies in response to the vaccine. Before the use of current anti-HIV medications, antibodies made to flu vaccination in HIV-positive individuals was related to their CD4 cell count. This trial will examine how CD4 counts and the amount of virus in the blood affect how much and what kind of antibodies the body makes to the flu vaccine. HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Healthy subjects will serve as controls to make sure the flu vaccine works (i.e., stimulates production of enough antibody to protect against the flu), and to compare the amount of antibodies made by HIV-positive and HIV-negative people. Candidates will be screened with a medical history and blood tests (see below). Women who are able to have children will have a pregnancy test. Pregnant women are excluded from the study. Participants will undergo the following procedures: Blood drawing for the following tests: Routine tests (complete blood count, kidney and liver functions, electrolyte levels). CD4 cell count. HLA typing (a genetic marker of the immune system) if it has not already been done at the NIH. This test may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions. Determining HLA type is necessary to be able to perform certain research studies. Some HLA types have been associated with an increased risk of certain diseases like arthritis and other rheumatologic problems. Viral load (HIV-infected patients only). Influenza antibody levels. B cell levels. Flu vaccination Follow-up visits on days, 7, 28, and 54 after vaccination for the following: Review of any illnesses or fever. Review of medications, if any changes were made. Repeat blood tests.
Detailed Description
The purpose of this protocol is to evaluate the effect of HIV viral load and CD4 counts on the generation of influenza-specific antibodies and influenza-specific B cell responses in HIV-infected adults. HIV-infected subjects will be enrolled to receive the influenza vaccine appropriate to the on-going USA influenza season (Oct-March). Laboratory studies (including influenza titers, influenza-specific B cell frequencies, CD4 counts, and HIV viral loads) will be obtained at baseline (day of vaccination), day 7, 28, and 54 post-vaccination. HIV-negative healthy volunteers will serve as controls. Although there are some risks to influenza vaccine, the CDC Advisory Committee on Immunizations recommends influenza vaccination for HIV-infected patients. The primary study risks are those of phlebotomy and the inconvenience of multiple visits. Subjects will be compensated for participation in the study. Total enrollment of the study is a maximum of 165 subjects (132 HIV-infected individuals and 33 HIV-negative controls).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Immunization, Immune Activation, Flu, Antibodies, Titers, HIV, Healthy Volunteer, HV

7. Study Design

Enrollment
165 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: HIV Positive: Age greater than or equal 18 but less than or equal to 60 years old and willing and able to give informed consent Enrollment during the USA influenza season (October-March) Self-reported history of HIV infection at enrollment (If NIH HIV testing does not confirm that the subject is HIV-positive, the subject will be discontinued from the study and not included in the analysis.) HIV Negative: Age greater than or equal to 18 but less than or equal to 60 years old and willing and able to give informed consent Enrollment during USA influenza season (October-March) Self-reported healthy HIV-negative (If NIH HIV testing does not confirm that the subject is HIV-negative, the subject will be discontinued from the study and not included in the analysis.) EXCLUSION CRITERIA: HIV Positive: Self-reported history of vaccination with the trivalent influenza preparation used for the current influenza season Self-reported vaccination with any vaccine within the one month period prior to study enrollment Acute febrile illness (may defer vaccine until resolved) History of hypersensitivity to any influenza vaccine components including thimerosal or egg History of Guillain-Barre syndrome Intention to receive any other vaccine during the study period Pregnancy Self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins, corticosteroids, or G(M)-CSF in the 4 weeks prior to enrollment Self-reported history of IL-2 administration within the past 5 years Use of theophylline preparations or warfarin because of the theoretical possibilities, of enhanced drug effects and toxicities post influenza vaccination Active infection or other serious illness other than HIV that might affect the immune response to a vaccine Current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with patient compliance and ability to make study visits HIV Negative: Self-reported history of vaccination with the trivalent influenza preparation used for the current influenza season Self-reported vaccination with any vaccine within the one month period prior to study enrollment Acute febrile illness (may defer vaccine until resolved) History of hypersensitivity to any influenza vaccine components including thimerosal or egg History of Guillain-Barre syndrome Intention to receive any other vaccine during the study period Pregnancy Self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins, corticosteroids, or G(M)-CSF in the 4 weeks prior to enrollment Use of theophylline preparations or warfarin because of the theoretical possibilities, of enhanced drug effects and toxicities post influenza vaccination Any medical conditions, or medication use might affect the immune response to a vaccine Current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with patient compliance and ability to make study visit
Facility Information:
Facility Name
National Institute of Allergy and Infectious Diseases (NIAID)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11717444
Citation
McNeil AC, Shupert WL, Iyasere CA, Hallahan CW, Mican JA, Davey RT Jr, Connors M. High-level HIV-1 viremia suppresses viral antigen-specific CD4(+) T cell proliferation. Proc Natl Acad Sci U S A. 2001 Nov 20;98(24):13878-83. doi: 10.1073/pnas.251539598.
Results Reference
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PubMed Identifier
12730375
Citation
Moir S, Ogwaro KM, Malaspina A, Vasquez J, Donoghue ET, Hallahan CW, Liu S, Ehler LA, Planta MA, Kottilil S, Chun TW, Fauci AS. Perturbations in B cell responsiveness to CD4+ T cell help in HIV-infected individuals. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6057-62. doi: 10.1073/pnas.0730819100. Epub 2003 May 1.
Results Reference
background
PubMed Identifier
10825608
Citation
Kroon FP, van Dissel JT, de Jong JC, Zwinderman K, van Furth R. Antibody response after influenza vaccination in HIV-infected individuals: a consecutive 3-year study. Vaccine. 2000 Jul 1;18(26):3040-9. doi: 10.1016/s0264-410x(00)00079-7.
Results Reference
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Immune Response to Influenza Vaccine in HIV-Infected Individuals

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