Influenza, HumanNCT01381029
Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals
An observational study of Influenza, Human and Human Immunodeficiency Virus I Infection, run by George Washington University at 1 site in United States.
Trial summary
Investigators in the Division of Infectious Diseases are carrying out a study to determine if human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza vaccination develop an adequate antibody response. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Influenza, Human, Human Immunodeficiency Virus I Infection
- Type of treatment
- Vaccines
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2014
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV positive individuals receiving influenza vaccine as part of standard of care.
Who may be able to join
- Males or female patients ages 18 or older
- Diagnosis of HIV infection
- No contraindications to being able to receive influenza vaccine by the treating physician
- No acute active illness
- Able to provide informed consent
Who cannot join
- Previous history of hypersensitivity reaction to influenza vaccine
- Unable to return for follow-up blood draw
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: A Study to Examine Immunological Response in HIV-Infected Patients Receiving the Seasonal Influenza Vaccine
Investigators in the Division of Infectious Diseases are carrying out a study to determine if human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza vaccination develop an adequate antibody response. The study group will consist of individuals seen in the Infectious Diseases Clinic who are HIV-seropositive and receive the Seasonal Influenza vaccine.
Read the detailed description
This is a study to establish the immunologic response in HIV-seropositive individuals to the FDA approved seasonal influenza vaccine when it is available. HIV-seropositive individuals seen in the Infectious Diseases Clinic at George Washington University, Medical Faculty Associates and receive this vaccination, on label, as part of standard of care will be invited to participate.
The study will require a 10-ml sample of whole blood to be drawn from each participant prior to the dose of the seasonal influenza vaccine and at 3 weeks after the vaccine dose and at 3 months after the vaccine dose. No additional samples are envisioned. Serum will be separated and will frozen and stored in the Clinical Trials Unit until all patient samples have been obtained. At that time the antibody levels to the vaccine antigens will be measured.
Data that will be collected from the subject's medical record includes the following:
- Age, gender, race
- CD4 count
- HIV viral load
- History of prior influenza immunization including the 2009-2010 trivalent vaccine
- HIV antiviral medication history
Data that will be collected from the subject during participation in study
- Antibody levels prior to vaccination
- Dose date of the seasonal influenza vaccination
- Antibody levels 3 weeks after the vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive | HIV positive, receiving Influenza vaccine as standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in antibody levels
The primary endpoint will be to measure the change from baseline in vaccine-strain specific antibody levels. Titers of > or = 40 U will be considered protective and a > 4-fold rise in antibody titer will be considered an adequate response in previously antibody-negative patients. Data from this study will assist in defining the efficacy of the influenza vaccine in the HIV-infected population and the ability of HIV-infected patients to generate an appropriate immune response, as well as maintain an appropriate response, to the influenza vaccine.
Measured: Pre-, 3 weeks post-, 3 months post- vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Siegel, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381029
- Sponsor's protocol ID
- IRB080911
- Status last verified
- May 2023
- First submitted
- 23 Jun 2011
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Examine Immunological Response in HIV-Infected Patients Receiving the Seasonal Influenza Vaccine
- ClinicalTrials.gov ID
- NCT01381029
- Acronym / sponsor ID
- IRB080911
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Jun 2011 (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.
Investigators in the Division of Infectious Diseases are carrying out a study to determine if human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza vaccination develop an adequate antibody response. The study group will consist of individuals seen in the Infectious Diseases Clinic who are HIV-seropositive and receive the Seasonal Influenza vaccine.
Detailed description
This is a study to establish the immunologic response in HIV-seropositive individuals to the FDA approved seasonal influenza vaccine when it is available. HIV-seropositive individuals seen in the Infectious Diseases Clinic at George Washington University, Medical Faculty Associates and receive this vaccination, on label, as part of standard of care will be invited to participate.
The study will require a 10-ml sample of whole blood to be drawn from each participant prior to the dose of the seasonal influenza vaccine and at 3 weeks after the vaccine dose and at 3 months after the vaccine dose. No additional samples are envisioned. Serum will be separated and will frozen and stored in the Clinical Trials Unit until all patient samples have been obtained. At that time the antibody levels to the vaccine antigens will be measured.
Data that will be collected from the subject's medical record includes the following:
- Age, gender, race
- CD4 count
- HIV viral load
- History of prior influenza immunization including the 2009-2010 trivalent vaccine
- HIV antiviral medication history
Data that will be collected from the subject during participation in study
- Antibody levels prior to vaccination
- Dose date of the seasonal influenza vaccination
- Antibody levels 3 weeks after the vaccination
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV positive | – | –HIV positive, receiving Influenza vaccine as standard of care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive individuals receiving influenza vaccine as part of standard of care.
Key inclusion criteria (5 listed)
- Males or female patients ages 18 or older
- Diagnosis of HIV infection
- No contraindications to being able to receive influenza vaccine by the treating physician
- No acute active illness
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Previous history of hypersensitivity reaction to influenza vaccine
- Unable to return for follow-up blood draw
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
Change in antibody levels
Time frame: Pre-, 3 weeks post-, 3 months post- vaccine
The primary endpoint will be to measure the change from baseline in vaccine-strain specific antibody levels. Titers of > or = 40 U will be considered protective and a > 4-fold rise in antibody titer will be considered an adequate response in previously antibody-negative patients. Data from this study will assist in defining the efficacy of the influenza vaccine in the HIV-infected population and the ability of HIV-infected patients to generate an appropriate immune response, as well as maintain an appropriate response, to the influenza vaccine.
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 19 May 2023.
- Individual participant dataSharing planned: No
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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.
Marc Siegel, MD principal investigator
George Washington University
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 Influenza, Human and Human Immunodeficiency Virus I Infection, run by George Washington University 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 5 inclusion and 2 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 19 May 2023. 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.
What does the primary outcome measure?
Change in antibody levels (time frame: Pre-, 3 weeks post-, 3 months post- vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2023.