Phase 4
N=40
Genomics and Epigenomics of the Elderly Response to Pneumococcal Vaccines
Pneumonia · Aging
Bottom Line
View on ClinicalTrials.gov: NCT03104075 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Pneumococcal-specific Antibody Responses — 72.1; 79.4; 128.9; 120.9 log2 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein (Biological); Pneumococcal Vaccine Polyvalent (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- The Jackson Laboratory
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pneumococcal-specific Antibody Responses |
72.1; 79.4; 128.9; 120.9 | — |
| PRIMARY Pneumococcal-specific Antibody Responses - Fold Change Post First Vaccination |
55.6; 41.6 | — |
| SECONDARY Number of Genes Upregulated Following Vaccination With PCV13 or PPSV23 |
26; 42 | — |
| SECONDARY Alterations to APCs, Tfh Cells or B Cells in Response to PCV13 and PPSV23 |
0.4; 0.5; 0.7; 1.6; 4.1; 4.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03104075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.