Elderly Influenza Vaccine Immunogenicity Substudy

Completed

Conditions studied: Influenza

In brief

The body's immune system (fights infection) is known to decline during the aging process, resulting in an increased risk of catching infections. Vaccinations also are not as effective in protecting older people against infection as they are in younger people. The purpose of this study is to better understand how and why vaccines are not as effective in older people. The researchers believe that the immune response in older people who get a higher dose vaccine will be similar to the immune response in young adults who get the standard (lower) dose vaccine. This study is a substudy to a main study, evaluating flu vaccines in people 65 years and older. Volunteers who are in the main study will be asked if they will participate in the substudy. The substudy requires them to give 2 additional blood samples for an in-depth look at their immune response to the flu vaccine given in the main study. Substudy volunteers will have up to 3 clinic visits and participate up to 28 weeks.

Key facts

Study ID

NCT00170482

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Starts

2005-04-25

Expected to finish

2005-05-30

Last updated by the study team

2019-01-28

Who can join

Age: 65 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Volunteers who participate in Division of Microbiology and Infectious Diseases (DMID) study 04-100, "Comparisons of the Reactogenicity and Immunogenicity in Ambulatory Elderly Subjects of a Standard-Dose Fluzone® (15 µg HA/Virus Strain) and a High-Dose (60 µg HA/Virus Strain) of a Trivalent Inactivated Influenza Virus Vaccine" 2. Ambulatory medically stable persons at least 65 years of age on the date of vaccination 2. Provides written informed consent and will be available for all study visits 4. Able to understand and comply with planned study procedures Subjects will be considered ambulatory if they are not institutionalized, bedridden, or homebound. Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs must be controlled with medical therapy. Subjects with acute febrile illnesses [oral temperature equal to or exceeding 99.5 degrees F (37.5 degrees C)] will be deferred until 3 days after illness resolution.

You may not qualify if…

• Known allergy to eggs or other components of the vaccine (eg, thimerosal) 2. History of a severe reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances 3. History of Guillain-Barré Syndrome 4. Immunosuppression as a result of underlying illness or treatment 5. Use of oral steroids, parenteral steroids, or high-dose inhaled steroids (> 800 µg per day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination 6. Use of other immunosuppressive or cytotoxic drugs or radiation therapy within the six months prior to vaccination 7. Active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy) 8. Acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus 9. Use of experimental vaccines or medications within the month prior to study entry, or expected use of experimental vaccines or medications during the entire study period, including the 6-month follow-up phone call, after inoculation with study vaccine 10. Use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period, including the 6-month follow-up phone call, after inoculation with study vaccine 11. Receipt of immunoglobulin or other blood product within 3 months prior to enrollment 12. Receipt of other licensed vaccines within the preceding 4 weeks or expected to receive a licensed vaccine within 1 month (prior to visit 2) following trial vaccination 13. Subject is enrolled in a conflicting clinical trial 14. Thrombocytopenia or bleeding disorder or therapy contraindicating intramuscular (IM) vaccination.

Where it is running

• University of Maryland School of Medicine - Center for Vaccine Development - Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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