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Status:

TERMINATED

Pneumococcal Conjugate Vaccine in Aging Renal Transplant

Lead Sponsor:

VA Office of Research and Development

Conditions:

Renal Transplantation

Aging

Eligibility:

All Genders

35-75 years

Phase:

EARLY_PHASE1

Brief 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 vacci...

Detailed Description

Objectives / Specific Aims Individuals \>65 years of age, are the most rapidly growing population amongst those with end stage renal disease (ESRD) and account for more than 18% of renal transplant (...

Eligibility Criteria

Inclusion

  • Inclusion criteria are group specific. HBV, HCV and HIV testing are not necessary in the RT groups as all RT recipients are tested prior to transplant. The investigators will not restrict volunteers with respect to gender, ethnic or racial group.
  • Groups 1 (65-75 yrs) and 2 (35-45 yrs) Renal Transplant populations
  • End stage renal disease cause either DM2 and/or hypertension (HTN)
  • Renal transplant \>12 months ago
  • Group 3: Diabetic/hypertensive 65-75 year old controls
  • With DM2 and/or HTN
  • Previous immunization with PPV23 \>1 year prior
  • Willingness to be tested for HIV, HBV and HCV
  • "normal kidney function" defined as glomerular filtration rate (GFR) of 60% or above
  • Group 4: Healthy Control 65-75 yr old
  • Without DM2
  • May have high blood pressure (systolic\>140 and/or diastolic\>90) as long as it is well controlled (systolic\<140 and/or diastolic \<90) and has not affected kidney function.
  • Previous receipt of PPV23 \> 1 year prior
  • Willingness to be tested for HIV, HBV and HCV
  • Group 5: Healthy Control 35-45 yr old
  • Without DM2.
  • May have high blood pressure (systolic\>140 and/or diastolic\>90) as long as it is well controlled (systolic\<140 and/or diastolic \<90) and has not affected kidney function.
  • Willingness to be tested for HIV, HBV and HCV and filling out a medical questionnaire that will include diabetes screening.

Exclusion

  • Exclusion criteria are either applicable to all groups or group specific. Therefore we have listed the exclusion criteria applicable to ALL groups first. Group specific criteria are listed under each group.
  • Exclusion Criteria common to all groups
  • Previous immunization with PCV13.
  • Pregnancy, no contraceptive practice in women of childbearing age, or breastfeeding
  • Known anaphylaxis, hypersensitivity or "bad allergic reaction" to the pneumonia vaccine. This does not include egg allergy or previous Guillan Barre syndrome.
  • Those who received blood products or gamma globulin within 3 months.
  • Inability to comprehend or sign the informed consent form
  • Previous/present illness that may affect immune response to the vaccine
  • previous pneumococcal disease
  • disease
  • removal of the spleen
  • auto-immune disease such as lupus or rheumatoid arthritis
  • end-stage liver disease
  • cancer
  • Significant abnormalities (3xULN and all those considered to be critical values) in CBC, chemistries including glucose.
  • HIV, HBsAg or HCV positivity
  • Receipt of PPV23 within 1 year
  • Groups 1 (65-75 yrs) and 2 (35-45 yrs) Renal Transplant populations
  • Medications that are known to affect immune function (chemotherapy, anti-TNF agents) with the exception of anti-rejection medication.
  • Episode of acute rejection within the last 6 month period
  • Group 3: Diabetic/hypertensive 65-75 year old controls
  • Medications that are known to affect immune function (chemotherapy, anti-TNF agents).
  • The inclusion/exclusion criteria will be determined by chart review.
  • Group 4: Healthy Control 65-75 yr old
  • Medications that are known to affect immune function (chemotherapy, anti-TNF agents).
  • The inclusion/exclusion criteria will be determined by chart review and pregnancy test for females of child bearing potential.
  • Group 5: Healthy Control 35-45 yr old
  • Medications that are known to affect immune function (chemotherapy, anti-TNF agents).
  • The inclusion/exclusion criteria will be determined by chart review and pregnancy test for females of child bearing potential.

Key Trial Info

Start Date :

November 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 28 2020

Estimated Enrollment :

57 Patients enrolled

Trial Details

Trial ID

NCT03802994

Start Date

November 1 2018

End Date

February 28 2020

Last Update

April 30 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States, 29401-5799

2

Medical University of South Carolina

Charleston, South Carolina, United States, 29425