St. Louis,
Missouri
63131
Purpose:
The purpose of this study is to compare a new higher-dose influenza virus vaccine to the
standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect
elderly against viral influenza but not as well as desired. It is expected that the higher
doses vaccine can be given with little reaction, but this needs to be tested. Up to 410
people ages 65 years and older will be recruited from the community and from existing
volunteer populations. Participants will receive either the high or standard dose injected
in the muscle, remain in the clinic for 20 minutes afterward, and maintain a daily memory
aid for 7 days. The memory aid will be reviewed by telephone 8-12 days after the injection
and return to the clinic or contacted by telephone 6 months after the injection.
Study summary:
Influenza is a common respiratory infection caused by several related viruses. Epidemics of
influenza occur each winter and are responsible for an average of about 36,000 deaths each
year in the United States. Most of these deaths occur among elderly persons and among
people of all ages who suffer from chronic diseases, particularly of the lungs and the
heart. Current influenza virus vaccines protect elderly persons against influenza, but not
as well as desired. One consideration for trying to increase protection is to increase the
vaccine dose, but there is some concern that increasing the dose may increase reactions to
the vaccine (such as sore arm, aches, or fever). One of the vaccine manufacturers has
prepared an experimental influenza virus vaccine with a dose that is higher than the
currently used dose. A previous study with the same high dose of the vaccine showed that it
was well tolerated with only increased reactions at the injection site compared to the usual
vaccine. Since the study, the high-dose vaccine has also been made without preservative
(thimerosal) and gelatin, which are in the standard vaccine. It is expected that this
vaccine can be given with little reaction, but this needs to be determined. It also needs
to be shown whether such a vaccine stimulates higher levels of infection-fighting proteins
(or antibodies) in the blood than standard doses of influenza vaccine. The purpose of this
research is to compare reactions and antibody responses following standard flu vaccine to
those following the experimental vaccine. Up to 410 people ages 65 years and older will be
recruited from the community and from existing volunteer populations. Participants will
receive either the high or standard dose injected in the muscle, remain in the clinic for 20
minutes afterward, and maintain a daily memory aid for 7 days. The memory aid will be
reviewed by telephone 8-12 days after the injection and return to the clinic or contacted by
telephone 6 months after the injection. This study is linked to DMID protocol 05-0028.
Criteria:
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for study
participation:
- Ambulatory medically stable persons >= 65 years of age on the date of vaccination
- Provides written informed consent and will be available for all study visits
- 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 99.5ºF (37.5ºC)] will be deferred until 3 days after illness
resolution.
Exclusion Criteria:
Subjects must not meet any of the following exclusion criteria in order to be eligible for
participation in this study:
- Known allergy to eggs or other components of the vaccine (eg, thimerosal);
- 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;
- History of Guillain-Barré Syndrome;
- Immunosuppression as a result of underlying illness or treatment;
- 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;
- Use of other immunosuppressive or cytotoxic drugs or radiation therapy within the six
months prior to vaccination;
- 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);
- 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;
- 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;
- 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;
- Receipt of immunoglobulin or other blood product within 3 months prior to enrollment;
- 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;
- Subject is enrolled in a conflicting clinical trial;
- Thrombocytopenia or bleeding disorder or therapy contraindicating IM vaccination.