Pneumococcal Conjugate Vaccine in Aging Renal Transplant

• Status: Terminated
• Trial end date: 2020-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Heptavalent Pneumococcal Conjugate Vaccine; Vaccines

Criteria

Inclusion Criteria:

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 Criteria:

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.