Pneumococcal Conjugate Vaccine in Aging Renal Transplant

Summary

The goal of the research proposed in the current application is to first define how much antibody aging renal transplant and dialysis recipients make after they are vaccinated with the pneumonia vaccine and how this compares to similar aged persons with good renal function and healthy young adults. The investigators will study differences in the kind of B cells and markers on the B cells that are known to be important in the response to the pneumonia vaccine in aging renal transplant and aging dialysis recipients compared to similarly aged and young healthy controls. Finally, the investigators will study how safe the pneumonia vaccine is in aging renal transplants. The answers to these questions will help in designing a better vaccine for older people with a renal transplant or on dialysis.

Conditions

• Renal Transplantation
• Aging

Interventions

DRUG

23 valent pneumococcal polysaccharide vaccine

FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 23 different pneumococcal serotypes. Only group 5 will potentially receive this as an intervention.

BIOLOGICAL

13 valent conjugated pneumococcal vaccine

FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197. Only group 5 will receive this as an intervention. In all other groups Prevnar 13 will be given as standard of care.

OTHER

Peripheral blood sample

Peripheral blood samples (30-60 mL) will be collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) for groups 1-4 and at days 366, 373 and 396 for group 5. In addition, day 5, and 10 blood samples will be obtained from a limited (n=10) number of elderly RT participants to determine the optimal time point for circulation of PPS-specific B cells. Yearly blood samples will be obtained thereafter for serum antibody and OPA analyses to test longevity of antibody and OPA responses. Samples obtained from days 0, 30 and yearly samples will be used for antibody titers and opsonophagocytic assays. Samples from day 0 (day of vaccination with PCV13) and day 7 will be used for flow cytometric analysis.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Maria J Westerink, MD · Ralph H. Johnson VA Medical Center, Charleston, SC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2020-02-28

Completion

2020-02-28

FDA Drug

Yes

Countries

• United States

Study Locations