©2022 Stanford Medicine
Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort
Not Recruiting
Trial ID: NCT03312699
Purpose
The purpose of this study is to use an existing, unique clinical cohort: the longitudinal
cohort of younger (21-40 years) and elderly (>65 years) subjects whose yearly influenza
vaccine responses have been studied extensively since 2007, to gain molecular and cellular
mechanistic insights into the impaired vaccine responses in the elderly.
Official Title
Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the
duration of the study.
3. Prior participant in either the Ellison cohort or another Stanford vaccine study with
archived samples.
4. Male or female, aged 18-40 years or 65 years and older.
5. In good general health as evidenced by medical history.
Exclusion Criteria:
1. Prior off-study vaccination with the current season influenza vaccine for influenza
vaccinations.
2. Allergy to egg or egg products
3. Allergy to vaccine components, including thimerosal
4. Active systemic or serious concurrent illness, including febrile illness on the day of
vaccination
5. Receipt of blood or blood products within the past 6 months of any study vaccination
or planned receipt of blood products prior to completion of Day 28 post-immunization
visit.
6. Receipt of inactivated vaccine 14 days prior to study vaccination or planned
vaccination prior to Day 28 after study vaccination.
7. Receipt of live, attenuated vaccine within 60 days of study vaccination or planned
vaccination prior to Day 28 after study vaccination.
8. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or
planned blood donation prior to Day 28 after study vaccination.
9. Use of investigational agents within 30 days prior to enrollment or planned use of
investigational agents prior to completion of all study visits.
10. Need for allergy immunizations (that cannot be postponed) between Days 0 and 28
post-immunization.
11. Pregnant or lactating woman for all but influenza vaccine. A woman who is pregnant or
breastfeeding may be evaluated by the Protocol Director to determine if influenza
vaccination would affect volunteer safety and may be included at the discretion of the
investigator. Blood sample collection will be adjusted as necessary for volunteer
safety (e.g. blood collection volume for a pregnant woman would follow the minimal
risk guidelines of 50 ml in an 8 week period and collection may not occur more
frequently than 2 times per week).
12. Any condition, which, in the opinion of the investigator, might interfere with
volunteer safety, study objectives or the ability of the participant to understand or
comply with the study protocol.
Intervention(s):
biological: Fluzone® quadrivalent
biological: Fluzone High Dose
biological: Fluad
biological: Vaqta
biological: Typhim Vi
biological: Vivotif
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305