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Genomics and Epigenomics of the Elderly Response to Pneumococcal Vaccines
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.
Details
| Lead sponsor | The Jackson Laboratory |
|---|---|
| Phase | PHASE4 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | Mon Apr 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sat Aug 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Pneumonia
- Aging
Interventions
- Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein
- Pneumococcal Vaccine Polyvalent
Countries
United States