Influenza Vaccine in HIV Infection: Immune Response and Effect on Viral Load

NCT00025922 | Completed

• 2 other identifiers: 02002602-I-0026
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This 2-part study will examine 1) the immune response to influenza (flu) vaccine in HIV-infected patients, and 2) the effect of flu vaccine on HIV viral loads. Earlier studies have shown that people with HIV infection do not respond as well to flu vaccine as healthy subjects; that is, they don't make as many antibodies in response to the vaccine. Also, studies done before the use of HAART (highly active antiretroviral treatment) have shown that HIV levels increase for a period of time after flu vaccination. One small study showed a small brief increase in HIV even in patients taking HAART. The current trial will examine whether the flu vaccine does, in fact, cause an elevation in viral load and whether this increase is harmful or indicates a better response to the vaccine. HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be eligible for part1of this study. (Healthy volunteers will serve as control subjects to make sure the flu vaccine stimulates production of enough antibody to protect against the flu). Part 2 will include only HIV-infected patients with fewer than 50 copies per milliliter of HIV. Patients in both parts of the study must have been receiving HAART (consisting of at least two nucleoside reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor) for at least 3 months before enrollment in the study. Candidates will be screened with a medical history and blood tests, including HLA testing (a genetic test of immune system markers). 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:

• Part 1 - Immune Response to Flu Vaccine In the first of two visits, participants will have blood drawn for flu antibody levels before vaccination and, in HIV-infected patients, measures of T cell count and viral load. They will then receive the flu vaccine. Blood will be drawn at a second visit 28 days later for the same tests.
• Part 2 - Effect of Flu Vaccine on Viral Levels Participants will be randomly assigned to receive the flu vaccine either at the beginning of their enrollment in the study (immediate) or 3 weeks after enrollment (deferred). Those in the immediate group receive the flu vaccine on the first day (day 0) and have blood drawn on days 0, 3, 7, 10, 14, 17, 21, 24, 28, 31, 35, 38 and 42. Those in the deferred group are vaccinated on day 21 and have blood drawn on days 0, 3, 7, 10, 14, 17, 21, 24, 28, 31, 35, 38, 42 and 49. The blood is tested for viral load, CD4 cell counts and antibody levels.

Conditions

HIV Infection

Keywords

Immunization; Titers; Immune Activation; Antibody; CD4 Cell Count; HIV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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
• Self-reported pre-vaccine CD4 count greater than or equal to 400 cells/microliter. If day 0 CD4 cell count testing reveals a CD4 count less than 400, subject will be put off study and only receive compensation for initial visit.
• Self-reported use of HAART for a minimum of three months prior to enrollment. For this study, HAART is defined as at least 2 nucleoside reverse transcriptase inhibitor plus either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor

You may not qualify if:

• 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 resovled)
• 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 (interluekins, corticosteroids, or G(M)-CSF) in the 4 weeks prior to enrollment. Epoetin use is permitted.
• Self-reported hidtory of IL-2 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, in the opinion of the investigator, 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
• 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 of 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 10825608 BACKGROUND

• Kroon FP, Rimmelzwaan GF, Roos MT, Osterhaus AD, Hamann D, Miedema F, van Dissel JT. Restored humoral immune response to influenza vaccination in HIV-infected adults treated with highly active antiretroviral therapy. AIDS. 1998 Dec 3;12(17):F217-23. doi: 10.1097/00002030-199817000-00002.

  PMID: 9863863 BACKGROUND

• Gunthard HF, Wong JK, Spina CA, Ignacio C, Kwok S, Christopherson C, Hwang J, Haubrich R, Havlir D, Richman DD. Effect of influenza vaccination on viral replication and immune response in persons infected with human immunodeficiency virus receiving potent antiretroviral therapy. J Infect Dis. 2000 Feb;181(2):522-31. doi: 10.1086/315260.

  PMID: 10669335 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 31, 2001
• First Posted: November 1, 2001
• Study Start: October 1, 2001
• Study Completion: October 1, 2003
• Last Updated: March 4, 2008

Record last verified: 2003-10

Locations

US (1)