InfluenzaNCT00996970
Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
An observational study of Influenza and HIV Infections, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites in United States.
Trial summary
The purpose of this research is to determine the effectiveness of the novel H1Nl influenza (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons. The administration of the H1Nl vaccination is not part of the study's procedures, but is being given as part of routine care. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, HIV Infections
- How many people
- 132 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2009to Dec 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Males and females of all races and all military beneficiaries including active duty enlisted and officers (from all branches of service), retirees, and their dependents presenting for H1N1 vaccination as part of routine clinical care will be eligible for participation. Both HIV-positive and negative persons can participate. Since most of our HIV patients are 18-50 years of age, and seroresponse varies by age, we will enroll persons between the ages of 18-50 years.
Who may be able to join
- 18-50 years of age
- Receiving the novel H1N1 vaccine (killed formulation) as part of routine clinical care
- A military beneficiary who expects to remain in the local area for the next 6 months
Who cannot join
- Healthcare worker who is involved in direct patient care
- Acute febrile illnesses within 30 days prior to H1N1 vaccination (e.g., pneumonia, influenza, ILI)
- Diabetes type 1 or type 2
- Systemic steroid or immunosuppressive medication use within 4 weeks of vaccination
- Active diagnoses of a cancer (non-melanoma skin cancer allowed).
- History of organ transplant
Show all 15Show fewer
- Chronic active hepatitis B or C
- Active illicit drug use or alcohol abuse
- Blood transfusion within the last year
- Allergy to eggs
- Previous significant adverse reaction (e.g., anaphylaxis) to the seasonal influenza vaccination
- History of serious reactions to any prior vaccination (e.g., Guillain Barre Syndrome (GBS)).
- Received another vaccination in the last 4 weeks (receipt of seasonal influenza vaccination is allowed)
- Among females of childbearing potential, pregnant or within 6 weeks of being postpartum
- History of ILI which was confirmed as an H1N1 infection
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Naval Medical Center San Diego
San Diego, California, 92134
About this study
The purpose of this research is to determine the effectiveness of the novel H1Nl influenza (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons. The administration of the H1Nl vaccination is not part of the study's procedures, but is being given as part of routine care.
Read the detailed description
The investigators study is being conducted to evaluate and compare the seroresponses of the novel H1N1 vaccination among HIV positive and negative persons receiving the novel H1N1 vaccination as part of routine clinical care, with secondary objectives examining the impact of prior seasonal vaccinations on subsequent seroresponse to the novel H1N1 vaccination, determining potential reactions (local or systemic) to this new vaccine among patients, and assessing for potential immunologic/virologic changes (in CD4/HIV RNA levels) after H1N1 vaccination among HIV patients. Finally, the investigators will collect data on influenza-like illnesses (ILI) and H1N1 events during the study follow-up period and influenza isolates causing ILI events will be genetically characterized.
- Conditions
- Influenza, HIV Infections
- Keywords
- HIV, H1N1, Influenza, Vaccination, Seroresponse, Immunogenicity, Vaccine
- Medical subject headings
- Influenza, Human, HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons.
Measured: interim = 2 months; 6 month f/u = 8 months
Secondary outcomes (8)
To compare the immunogenicity via HAI titer levels, microneutralization seroresponses and titer levels, and cellular responses following H1N1 vaccination between HIV positive and negative persons.
Measured: 1 year
Among those undergoing vaccination with the seasonal influenza vaccine during the current influenza season, to compare the presence of a positive seroresponse between HIV positive and negative persons
Measured: 1 year
To evaluate the effect of pre-existing anti-influenza immunity and recent history of seasonal influenza vaccination on seroresponses to the H1N1 influenza vaccine among both HIV positive and negative persons.
Measured: 1 year
To compare the durability of the H1N1 immunologic responses at 6 months post-vaccination between HIV-infected and uninfected persons.
Measured: 1 year
To evaluate the number of ILIs and documented influenza cases among HIV-infected and uninfected persons after initial vaccination, and to genetically characterize the influenza strains causing ILI events in our study cohort.
Measured: 1 year
To evaluate the impact of CD4 counts/percentages, HIV RNA levels, and HAART use on the immunologic responses to H1N1 vaccination in HIV positive subjects.
Measured: 1 year
To evaluate the impact of the H1N1 vaccine on CD4 counts/percentages and HIV RNA levels in HIV positive subjects.
Measured: 2 months
To evaluate potential adverse reactions of the H1N1 vaccine in HIV positive versus negative subjects.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Clinical Research Program, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996970
- Sponsor's protocol ID
- IDCRP-053
- Status last verified
- Mar 2023
- First submitted
- 15 Oct 2009
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Crum-Cianflone NF, Eberly LE, Duplessis C, Maguire J, Ganesan A, Faix D, Defang G, Bai Y, Iverson E, Lalani T, Whitman T, Blair PJ, Brandt C, Macalino G, Burgess T. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in an immunocompromised population: a prospective study comparing HIV-infected adults with HIV-uninfected adults. Clin Infect Dis. 2011 Jan 1;52(1):138-46. doi: 10.1093/cid/ciq019. Epub 2010 Dec 7.
PubMed 21148532
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
- ClinicalTrials.gov ID
- NCT00996970
- Acronym / sponsor ID
- IDCRP-053
- Conditions
- Influenza, HIV Infections
- Keywords
- HIV, H1N1, Influenza, Vaccination, Seroresponse, Immunogenicity, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Infectious Diseases Clinical Research Program, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Oct 2009 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 16 Oct 2009 (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.
The purpose of this research is to determine the effectiveness of the novel H1Nl influenza (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons. The administration of the H1Nl vaccination is not part of the study's procedures, but is being given as part of routine care.
Detailed description
The investigators study is being conducted to evaluate and compare the seroresponses of the novel H1N1 vaccination among HIV positive and negative persons receiving the novel H1N1 vaccination as part of routine clinical care, with secondary objectives examining the impact of prior seasonal vaccinations on subsequent seroresponse to the novel H1N1 vaccination, determining potential reactions (local or systemic) to this new vaccine among patients, and assessing for potential immunologic/virologic changes (in CD4/HIV RNA levels) after H1N1 vaccination among HIV patients. Finally, the investigators will collect data on influenza-like illnesses (ILI) and H1N1 events during the study follow-up period and influenza isolates causing ILI events will be genetically characterized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Males and females of all races and all military beneficiaries including active duty enlisted and officers (from all branches of service), retirees, and their dependents presenting for H1N1 vaccination as part of routine clinical care will be eligible for participation. Both HIV-positive and negative persons can participate. Since most of our HIV patients are 18-50 years of age, and seroresponse varies by age, we will enroll persons between the ages of 18-50 years.
Key inclusion criteria (3 listed)
- 18-50 years of age
- Receiving the novel H1N1 vaccine (killed formulation) as part of routine clinical care
- A military beneficiary who expects to remain in the local area for the next 6 months
Key exclusion criteria (15 listed)
- Healthcare worker who is involved in direct patient care
- Acute febrile illnesses within 30 days prior to H1N1 vaccination (e.g., pneumonia, influenza, ILI)
- Diabetes type 1 or type 2
- Systemic steroid or immunosuppressive medication use within 4 weeks of vaccination
- Active diagnoses of a cancer (non-melanoma skin cancer allowed).
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
To compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons.
Time frame: interim = 2 months; 6 month f/u = 8 months
8 secondary outcomes
To compare the immunogenicity via HAI titer levels, microneutralization seroresponses and titer levels, and cellular responses following H1N1 vaccination between HIV positive and negative persons.
Time frame: 1 year
Among those undergoing vaccination with the seasonal influenza vaccine during the current influenza season, to compare the presence of a positive seroresponse between HIV positive and negative persons
Time frame: 1 year
To evaluate the effect of pre-existing anti-influenza immunity and recent history of seasonal influenza vaccination on seroresponses to the H1N1 influenza vaccine among both HIV positive and negative persons.
Time frame: 1 year
To compare the durability of the H1N1 immunologic responses at 6 months post-vaccination between HIV-infected and uninfected persons.
Time frame: 1 year
To evaluate the number of ILIs and documented influenza cases among HIV-infected and uninfected persons after initial vaccination, and to genetically characterize the influenza strains causing ILI events in our study cohort.
Time frame: 1 year
To evaluate the impact of CD4 counts/percentages, HIV RNA levels, and HAART use on the immunologic responses to H1N1 vaccination in HIV positive subjects.
Time frame: 1 year
To evaluate the impact of the H1N1 vaccine on CD4 counts/percentages and HIV RNA levels in HIV positive subjects.
Time frame: 2 months
To evaluate potential adverse reactions of the H1N1 vaccine in HIV positive versus negative subjects.
Time frame: 2 months
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 22 Mar 2023.
- Derived from this study: PubMed 21148532Crum-Cianflone NF, Eberly LE, Duplessis C, Maguire J, Ganesan A, Faix D, Defang G, Bai Y, Iverson E, Lalani T, Whitman T, Blair PJ, Brandt C, Macalino G, Burgess T. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in an immunocompromised population: a prospective study comparing HIV-infected adults with HIV-uninfected adults. Clin Infect Dis. 2011 Jan 1;52(1):138-46. doi: 10.1093/cid/ciq019. Epub 2010 Dec 7.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and HIV Infections, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites 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 3 inclusion and 15 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
To compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons. (time frame: interim = 2 months; 6 month f/u = 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00996970, which also lists 1 linked publication.
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 22 Mar 2023.