Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort

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Brief Title

Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort

Official Title

Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort

Brief Summary

      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.
    

Detailed Description

      This is a phase IV study of sixty 21-40 and >65 year old adult volunteers who previously
      participated in vaccine studies with our program. All participation is by invitation only.

      The volunteers will be enrolled into two groups. Group A: Up to 30 healthy adult volunteers
      age 21-40 who will be given seasonal quadrivalent inactivated influenza vaccine (IIV4) prior
      to flu season for each of 5 years. They will also be given an inactivated Hepatitis A vaccine
      in the spring of years 1 and 2. Each volunteer will complete a total of 4 visits for each
      immunization: Day 0 (pre-immunization), Day 6-8, Day 12-15, and Day 26-30
      (post-immunization). All visits will consist of drawing blood for study assays and monitoring
      for serious adverse events (SAEs).

      A subset of this group will be randomized to receive either a Typhoid Vi Polysaccharide
      Vaccine or Typhoid Vaccine Live Oral Ty21a vaccine in year 3. Each volunteer will complete a
      total of 4 visits for this immunization: Day 0 (pre-immunization), Day 6-8 post completion of
      injection or final oral dose, Day 12-15 and Day 26-30 (post-immunization). All visits will
      consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

      Group B: Up to 30 healthy adult volunteers age 65 plus who will be randomized and given
      seasonal trivalent high dose inactivated influenza vaccine (IIV3) or trivalent adjuvanted
      trivalent inactivated influenza vaccine (Fluad) prior to flu season for each of 5 years. They
      will also be given an inactivated Hepatitis A vaccine in the spring of years 1 and 2 and
      aTyphoid Vi Polysaccharide Vaccine in year 3. Each volunteer will complete a total of 4
      visits for each immunization: Day 0 (pre-immunization), Day 6-8, Day 12-15, and Day 26-30
      (post-immunization). All visits will consist of drawing blood for study assays and monitoring
      for serious adverse events (SAEs).

      A subset of subjects (with a target of 10 younger and 10 older subjects depending on health),
      will undergo bone marrow aspirates one or two years after typhoid vaccination.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

hemagglutination inhibition assay (HAI) titers

Secondary Outcome

 related AEs occurring during the 28 days post vaccination

Condition

Influenza

Intervention

Fluzone® quadrivalent

Study Arms / Comparison Groups

 Group A IIV4
Description:  Group A: Up to 30 healthy volunteers 18-40 years old, will be given seasonal quadrivalent inactivated influenza vaccine (IIV4) Fluzone® Quadrivalent vaccine. Each volunteer will complete a total of 4 visits: Day 0 (pre-immunization), Day 6-8, Day 12-16, and Day 28+ 7 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

54

Start Date

September 19, 2017

Completion Date

December 2022

Primary Completion Date

December 2022

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Scott Boyd, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03312699

Organization ID

40216

Secondary IDs

R01AI130398-01

Responsible Party

Principal Investigator

Study Sponsor

Stanford University

Collaborators

 National Institute of Allergy and Infectious Diseases (NIAID)

Study Sponsor

Scott Boyd, MD, PhD, Principal Investigator, Stanford School of Medicine, Dept. of Pathology


Verification Date

April 2019