Influenza Clinical Trial
— SLVP033Official title:
Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort
Verified date | January 2024 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford LPCH Vaccine Program | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hemagglutination inhibition assay (HAI) titers | HAI titers measured at Days 0 and 28 for influenza. | Day 0 to Day 28 | |
Secondary | related AEs occurring during the 28 days post vaccination | related AEs occurring during the 28 days post vaccination for each of the vaccination types (Influenza, Hepatitis A, Typhoid) | Day 0 to Day 28 post-each immunization |
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