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HIV InfectionsNCT00069914

Immune Response to Influenza Vaccine in HIV-Infected Individuals

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
HIV Infections
How many people
165 participants
Where
1 siteUnited States
Study dates
Sep 2003to Sep 2005
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institute of Allergy and Infectious Diseases (NIAID)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Immune Response to Influenza Vaccination in HIV-Infected Individuals

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.

Read more

Participants will undergo the following procedures:

  1. 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.
  1. Flu vaccination
  2. 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.
Read the 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).

Conditions
HIV Infections
Keywords
Immunization, Immune Activation, Flu, Antibodies, Titers, HIV, Healthy Volunteer, HV
Medical subject headings
HIV Infections, Influenza, Human

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2003 (estimated)
  2. Study startSep 2003
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
165 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00069914
Sponsor's protocol ID
030310
Other IDs
03-I-0310
Status last verified
Sep 2005
First submitted
2 Oct 2003
Last updated
4 Mar 2008
Results posted
No

Publications

  • 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.

    PubMed 11717444

  • 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.

    PubMed 12730375

  • 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.

    PubMed 10825608

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00069914, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

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