HIV InfectionNCT00025922
Influenza Vaccine in HIV Infection: Immune Response and Effect on Viral Load
An observational study of HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Oct 2003
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
- 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
- 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, 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Official title: Influenza Vaccine in HIV Infection: Immunologic Responses and Effect on HIV Viral Load
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.
Read more
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.
Read the detailed description
This two-part protocol will evaluate: Part 1: the response to influenza vaccine in HIV-infected adults receiving highly active antiretroviral therapy (HAART); and Part 2: the effect of influenza vaccine on HIV-viral load (Part 2). The purpose of Part 1 is to evaluate the effect of HIV viral load on the generation of influenza-specific antibodies. 95 HIV-infected subjects with any CD4 cell count and HIV viral load on HAART will be enrolled to receive the influenza vaccine appropriate to the on-going influenza season and to have laboratory studies (including influenza titers, CD4 counts, and HIV viral loads) obtained at baseline and 28 days post vaccination; 15 HIV-negative healthy volunteers will serve as controls to demonstrate that the vaccine preparation can induce protective immunity. The purpose of Part 2 is to assess the potential effect of vaccine-associated immune activation on HIV viral replication in 30 HIV-infected subjects on HAART who have suppressed HIV viremia (less than 50 copies/mL) at the screening visit. These subjects will be randomized to receive the influenza vaccine appropriate to the on-going influenza season immediately or 3 weeks after enrollment. Both groups will have frequent blood draws for HIV viral load with the 3 weeks immediately after vaccine serving as the vaccine response period and the other 3 weeks serving as the control period for each subject. All subjects will have pre-vaccine and 28 day post vaccine influenza titers determined to see if there is a relationship between HIV viral load increases and vaccine responses. Subjects will be compensated for participation in both parts of the study. Those subjects who are ineligible for Part 2 because their screening HIV viral loads are greater than 50 copies/mL will be invited to participate in Part 1. This study will be conducted during the USA influenza season (Oct-March). Thus, the primary study risks are those of phlebotomy and inconvenience. Although there are some risks to influenza vaccine, the ACIP recommends influenza vaccination for HIV-infected patients. Finally, for subjects deferring vaccination for three weeks, there is presumably an increased risk of developing influenza. Total enrollment of the study is 140 subjects (125 HIV-infected individuals and 15 HIV-negative controls).
- Conditions
- HIV Infection
- Keywords
- Immunization, Titers, Immune Activation, Antibody, CD4 Cell Count, HIV
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2001 (estimated)
- Study startOct 2001
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 240 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025922
- Sponsor's protocol ID
- 020026
- Other IDs
- 02-I-0026
- Status last verified
- Oct 2003
- First submitted
- 31 Oct 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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 10825608Kroon 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.
PubMed 9863863Gunthard 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.
PubMed 10669335
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccine in HIV Infection: Immunologic Responses and Effect on HIV Viral Load
- ClinicalTrials.gov ID
- NCT00025922
- Acronym / sponsor ID
- 020026
- Conditions
- HIV Infection
- Keywords
- Immunization, Titers, Immune Activation, Antibody, CD4 Cell Count, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2001
- Study completion
- Oct 2003
- First posted
- 1 Nov 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This two-part protocol will evaluate: Part 1: the response to influenza vaccine in HIV-infected adults receiving highly active antiretroviral therapy (HAART); and Part 2: the effect of influenza vaccine on HIV-viral load (Part 2). The purpose of Part 1 is to evaluate the effect of HIV viral load on the generation of influenza-specific antibodies. 95 HIV-infected subjects with any CD4 cell count and HIV viral load on HAART will be enrolled to receive the influenza vaccine appropriate to the on-going influenza season and to have laboratory studies (including influenza titers, CD4 counts, and HIV viral loads) obtained at baseline and 28 days post vaccination; 15 HIV-negative healthy volunteers will serve as controls to demonstrate that the vaccine preparation can induce protective immunity. The purpose of Part 2 is to assess the potential effect of vaccine-associated immune activation on HIV viral replication in 30 HIV-infected subjects on HAART who have suppressed HIV viremia (less than 50 copies/mL) at the screening visit. These subjects will be randomized to receive the influenza vaccine appropriate to the on-going influenza season immediately or 3 weeks after enrollment. Both groups will have frequent blood draws for HIV viral load with the 3 weeks immediately after vaccine serving as the vaccine response period and the other 3 weeks serving as the control period for each subject. All subjects will have pre-vaccine and 28 day post vaccine influenza titers determined to see if there is a relationship between HIV viral load increases and vaccine responses. Subjects will be compensated for participation in both parts of the study. Those subjects who are ineligible for Part 2 because their screening HIV viral loads are greater than 50 copies/mL will be invited to participate in Part 1. This study will be conducted during the USA influenza season (Oct-March). Thus, the primary study risks are those of phlebotomy and inconvenience. Although there are some risks to influenza vaccine, the ACIP recommends influenza vaccination for HIV-infected patients. Finally, for subjects deferring vaccination for three weeks, there is presumably an increased risk of developing influenza. Total enrollment of the study is 140 subjects (125 HIV-infected individuals and 15 HIV-negative controls).
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 10825608Kroon 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.
- Background: PubMed 9863863Kroon 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.
- Background: PubMed 10669335Gunthard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, 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 22 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 NCT00025922, 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.