Genomics and Epigenomics of the Elderly Response to Pneumococcal Vaccines
Condition: Pneumonia; Aging
MeSH terms: Pneumonia
Intervention: Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein; Pneumococcal Vaccine Polyvalent
Intervention description: One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Pneumovax 23; One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Prevnar-13
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized assignment to group will be in a 1:1 ratio utilizing block randomization in blocks of 10 to receive Prevnar-13 or Pneumovax 23. Following randomized assignment of vaccine, the study will be open-label.
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Genomics; Epigenomics; Pneumococcal vaccine; Elderly

Summary:

      This is a prospective, single-site, randomized, then open-label study designed to develop a
      detailed transcriptional and epigenetic profile of the immune response to pneumococcal
      vaccination with conjugated and non-conjugated polysaccharide vaccines in the senescent
      immune system of older adults.

      In this study, 40 healthy adults ages 60 and older that have never received pneumococcal
      vaccination, will be randomized in a 1:1 ratio to receive Prevnar-13 (Pfizer), a conjugated
      13-valent vaccine or Pneumovax 23 (Merck), a non-conjugated 23-valent vaccine. Following
      randomized assignment of vaccine, the study will be open-label.

      Six (6) study visits will occur over about 70 days, with an optional 7th visit for
      participants to receive a second vaccination with the other pneumococcal vaccine one to two
      years after randomization. Participants will provide blood samples for transcriptional,
      epigenetic and biological analyses pre- and post-vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able and willing to provide written informed consent

          -  Male or Female, 60 years of age or older

          -  Willing to receive pneumococcal vaccination with Prevnar 13 (Wyeth/ Pfizer) or
             Pneumovax 23 (Merck), as randomly assigned.

          -  Available to attend 6 study visits over 67 days (Visit 7 is optional at Day 365-720).

        Exclusion Criteria:

          -  Previous pneumococcal vaccination with Prevnar 13 or Pneumovax 23.

          -  History of anaphylactic/anaphylactoid or severe allergic reaction to any component of
             Pneumovax 23, Prevnar 13 or any diphtheria toxoid-containing vaccine.

          -  Established diagnosis of diabetes

          -  History of receiving Zostavax (shingles vaccine) within previous 4 weeks. (Study entry
             may be delayed to satisfy a 28-day interval between vaccinations)

          -  Known history of any of the following co-morbid conditions:

               -  Malignancy (participants without a recurrence in the last 5 years will be
                  allowed)

               -  Congestive Heart Failure

               -  Cardiovascular Disease (unstable ≤ 6 months*)

               -  Kidney disease

               -  Renal failure

               -  Impaired hepatic function

               -  Autoimmune disease such as: Rheumatoid Arthritis, systemic lupus erythematosus
                  (SLE), Inflammatory Bowel Disease, etc.

               -  Use of medicines during past 6 months known to alter immune response such as
                  high-dose corticosteroids

               -  HIV, AIDS or other Immunodeficiency

               -  Recent (≤ 3 months) trauma or surgery

               -  Current substance and/or alcohol abuse * Unstable disease is defined as a change
                  in therapy or hospitalization for worsening disease.