Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons
1 other identifier
observational
132
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2009
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 15, 2009
CompletedFirst Posted
Study publicly available on registry
October 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 22, 2023
March 1, 2023
2 months
October 15, 2009
March 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons.
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.
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
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.
1 year
To compare the durability of the H1N1 immunologic responses at 6 months post-vaccination between HIV-infected and uninfected persons.
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.
1 year
- +3 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Naval Medical Center San Diego
San Diego, California, 92134, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708, United States
Related Publications (1)
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.
PMID: 21148532DERIVED
Biospecimen
Blood samples will be collected for immunologic studies including antibody titers and cellular responses. Viral isolates will be obtained and characterized among ILI cases during study participation. Blood for CD4/HIV RNA levels will also be obtained among HIV patients to determine the impact of the vaccine on these counts.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2009
First Posted
October 16, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2022
Last Updated
March 22, 2023
Record last verified: 2023-03