Trial Outcomes & Findings for Pneumococcal Conjugate Vaccine in Aging Renal Transplant (NCT NCT03802994)

Last Updated: 2021-04-30

Results Overview

Measure the opsonic antibody response against streptococcus pneumonia serotypes 14, 19A and 23F at days 0 and 30. Comparing elderly RT recipients versus healthy elderly and elderly with DM/HTN.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

57 participants

Primary outcome timeframe

Baseline, 30 days

Results posted on

2021-04-30

Participant Flow

Unit of analysis: prevnar vaccine

Participant milestones

Participant milestones
Measure	1.Aging RT Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. 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.	2.Young RT Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. 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.	3.Healthy Elderly Healthy persons between the ages 65-75 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) 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.	4.Elderly DMII or HTN and Normal Renal Function Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) 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.	5.Healthy Young Healthy persons between the ages 35-45 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) or are willing to receive PPV23 and 1 year later Prevnar 13. 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. 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. 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.
Overall Study STARTED	9 9	12 12	15 15	11 11	10 10
Overall Study COMPLETED	9 9	10 10	12 12	9 9	8 8
Overall Study NOT COMPLETED	0 0	2 2	3 3	2 2	2 2

Reasons for withdrawal

Reasons for withdrawal
Measure	1.Aging RT Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. 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.	2.Young RT Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. 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.	3.Healthy Elderly Healthy persons between the ages 65-75 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) 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.	4.Elderly DMII or HTN and Normal Renal Function Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) 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.	5.Healthy Young Healthy persons between the ages 35-45 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) or are willing to receive PPV23 and 1 year later Prevnar 13. 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. 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. 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.
Overall Study Lost to Follow-up	0	2	3	2	2

Baseline Characteristics

Pneumococcal Conjugate Vaccine in Aging Renal Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1.Aging RT n=9 Participants Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 was used for flow cytometric analysis.	2.Young RT n=12 Participants Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0, 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	3.Healthy Elderly n=15 Participants Healthy persons between the ages 65-75 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23). Samples obtained from days 0, 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 was used for flow cytometric analysis.	4.Elderly DMII or HTN and Normal Renal Function n=11 Participants Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30. Samples from day 7 were used for flow cytometric analysis.	5.Healthy Young n=10 Participants Healthy persons between the ages 35-45 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). 23 valent pneumococcal polysaccharide vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 23 different pneumococcal serotypes. All young healthy participants recruited were already immunized with pneumovax at least one year prior to enrollment 13 valent conjugated pneumococcal vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197 was adminstered at day 0. Only group 5 received this as an intervention. In all other groups Prevnar 13 was given as standard of care. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0, 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	12 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	10 Participants n=31 Participants	22 Participants n=30 Participants
Age, Categorical >=65 years	9 Participants n=99 Participants	0 Participants n=107 Participants	15 Participants n=206 Participants	11 Participants n=7 Participants	0 Participants n=31 Participants	35 Participants n=30 Participants
Age, Continuous	67 years n=99 Participants	41 years n=107 Participants	66 years n=206 Participants	66 years n=7 Participants	40 years n=31 Participants	65 years n=30 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	4 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	2 Participants n=31 Participants	7 Participants n=30 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	8 Participants n=107 Participants	15 Participants n=206 Participants	11 Participants n=7 Participants	8 Participants n=31 Participants	50 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	9 Participants n=99 Participants	9 Participants n=107 Participants	9 Participants n=206 Participants	6 Participants n=7 Participants	2 Participants n=31 Participants	35 Participants n=30 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants	5 Participants n=7 Participants	8 Participants n=31 Participants	22 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Region of Enrollment United States	9 Participants n=99 Participants	12 Participants n=107 Participants	15 Participants n=206 Participants	11 Participants n=7 Participants	10 Participants n=31 Participants	57 Participants n=30 Participants

PRIMARY outcome

Timeframe: Baseline, 30 days

Population: Participants who completed PCV13 immunization and from whom blood samples were obtained on day 0, 7, and 30. There is thus a discrepancy between the number of enrolled and analyzed participants in groups 2,3,4 and 5.

Measure the opsonic antibody response against streptococcus pneumonia serotypes 14, 19A and 23F at days 0 and 30. Comparing elderly RT recipients versus healthy elderly and elderly with DM/HTN.

Outcome measures

Outcome measures
Measure	1.Aging RT n=9 Participants Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	2.Young RT n=10 Participants Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	3.Healthy Elderly n=12 Participants Healthy persons between the ages 65-75 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	4.Elderly DMII or HTN and Normal Renal Function n=9 Participants Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	5.Healthy Young n=8 Participants Healthy persons between the ages 35-45 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) 13 valent conjugated pneumococcal vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197 was used for immunization at day 0. Only group 5 received this as an intervention. In all other groups Prevnar 13 will be given as standard of care. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.
Anti-pneumococcal IgG Antibody (ug/ml) Change Anti-PPS 14 IgG day 0	11.16 microgram/ml Standard Deviation 10.52	9.29 microgram/ml Standard Deviation 8.52	6.46 microgram/ml Standard Deviation 5.34	7.69 microgram/ml Standard Deviation 7.38	6.51 microgram/ml Standard Deviation 5.6663
Anti-pneumococcal IgG Antibody (ug/ml) Change Anti-PPS14 IgG day 30	14.55 microgram/ml Standard Deviation 10.94	13.92 microgram/ml Standard Deviation 11.62	10.42 microgram/ml Standard Deviation 8.04	13.05 microgram/ml Standard Deviation 9.44	15.75 microgram/ml Standard Deviation 10.82
Anti-pneumococcal IgG Antibody (ug/ml) Change Anti-PPS23F IgG day 30	6.96 microgram/ml Standard Deviation 5.39	4.57 microgram/ml Standard Deviation 5.56	5.18 microgram/ml Standard Deviation 3.80	11.55 microgram/ml Standard Deviation 7.44	9.69 microgram/ml Standard Deviation 5.11
Anti-pneumococcal IgG Antibody (ug/ml) Change Anti-PPS 19A IgG day 30	14.82 microgram/ml Standard Deviation 10.40	9.28 microgram/ml Standard Deviation 6.84	10.43 microgram/ml Standard Deviation 7.96	10.54 microgram/ml Standard Deviation 8.83	8.35 microgram/ml Standard Deviation 8.82
Anti-pneumococcal IgG Antibody (ug/ml) Change Anti-PPS23F IgG day 0	3.09 microgram/ml Standard Deviation 4.04	2.84 microgram/ml Standard Deviation 3.22	1.10 microgram/ml Standard Deviation 1.06	3.85 microgram/ml Standard Deviation 3.73	2.52 microgram/ml Standard Deviation 2.35
Anti-pneumococcal IgG Antibody (ug/ml) Change Anti-PPS19A IgG day 0	4.79 microgram/ml Standard Deviation 2.97	6.66 microgram/ml Standard Deviation 5.79	5.42 microgram/ml Standard Deviation 6.62	3.65 microgram/ml Standard Deviation 5.42	3.42 microgram/ml Standard Deviation 1.43

PRIMARY outcome

Timeframe: Baseline and 30 days

Population: Healthy elderly versus elderly with DM versus elderly with RT

Measure the serum opsonophagocytic activity against streptococcus pneumonia serotypes 14, 19A and 23F on days 0 and 30 by opsonophagocytic assay.

Outcome measures

Outcome measures
Measure	1.Aging RT n=9 Participants Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	2.Young RT n=10 Participants Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	3.Healthy Elderly n=12 Participants Healthy persons between the ages 65-75 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	4.Elderly DMII or HTN and Normal Renal Function n=9 Participants Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	5.Healthy Young n=8 Participants Healthy persons between the ages 35-45 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) 13 valent conjugated pneumococcal vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197 was used for immunization at day 0. Only group 5 received this as an intervention. In all other groups Prevnar 13 will be given as standard of care. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.
Opsonophagocytic Antibody Titer Serum Dilution Difference Between Healthy Elderly, Elderly With DM/HTN and Elderly With RT. opsonophagocytic titer PPS 14 day 0	1081 titer Standard Deviation 2810	147 titer Standard Deviation 295	3024 titer Standard Deviation 6478	256 titer Standard Deviation 663	811 titer Standard Deviation 2451
Opsonophagocytic Antibody Titer Serum Dilution Difference Between Healthy Elderly, Elderly With DM/HTN and Elderly With RT. opsonophagocytic titer PPS14 day 30	3117 titer Standard Deviation 5860	275 titer Standard Deviation 552	5954 titer Standard Deviation 8117	2477 titer Standard Deviation 4857	3687 titer Standard Deviation 7288
Opsonophagocytic Antibody Titer Serum Dilution Difference Between Healthy Elderly, Elderly With DM/HTN and Elderly With RT. opsonophagocytic titer PPS23F day 0	3.4 titer Standard Deviation 2.8	28 titer Standard Deviation 77	6.3 titer Standard Deviation 6.3	3.3 titer Standard Deviation 4.1	29 titer Standard Deviation 56
Opsonophagocytic Antibody Titer Serum Dilution Difference Between Healthy Elderly, Elderly With DM/HTN and Elderly With RT. opsonophagocytic titer PPS23F day 30	617 titer Standard Deviation 1617	38 titer Standard Deviation 64	1455 titer Standard Deviation 4822	469 titer Standard Deviation 904	914 titer Standard Deviation 2310
Opsonophagocytic Antibody Titer Serum Dilution Difference Between Healthy Elderly, Elderly With DM/HTN and Elderly With RT. opsonophagocytic titer PPS19A day 0	633 titer Standard Deviation 1891	7 titer Standard Deviation 10	15 titer Standard Deviation 21	663 titer Standard Deviation 2324	461 titer Standard Deviation 1407
Opsonophagocytic Antibody Titer Serum Dilution Difference Between Healthy Elderly, Elderly With DM/HTN and Elderly With RT. opsonophagocytic titer PPS 19A day 30	3893 titer Standard Deviation 7711	138 titer Standard Deviation 231	4529 titer Standard Deviation 7549	4634 titer Standard Deviation 7597	2290 titer Standard Deviation 5462

PRIMARY outcome

Timeframe: day 7

Population: Participants who completed PCV13 immunization and from whom blood samples were obtained on day 0, 7, and 30. Elderly healthy versus elderly with DM/HTN and elderly RT

percentage of polysaccharide specific B cells, and percentage of IgM memory B cells/mL in % cells/mL induced by vaccination with PCV13

Outcome measures

Outcome measures
Measure	1.Aging RT n=9 Participants Renal transplant recipients between 65-75 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	2.Young RT n=10 Participants Renal transplant recipients between 35-45 years of age, on stable immunosuppression. who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23). Cause or renal failure was either DMII or HTN. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	3.Healthy Elderly n=12 Participants Healthy persons between the ages 65-75 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	4.Elderly DMII or HTN and Normal Renal Function n=9 Participants Persons between the ages 65-75 with DMII or hypertension but normal renal function who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.	5.Healthy Young n=8 Participants Healthy persons between the ages 35-45 who previously (\>1 year prior) received the 23 valent pneumococcal polysaccharide vaccine (pneumovax23) 13 valent conjugated pneumococcal vaccine: FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197 was used for immunization at day 0. Only group 5 received this as an intervention. In all other groups Prevnar 13 will be given as standard of care. Peripheral blood sample: Peripheral blood samples (30-60 mL) were collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) Samples obtained from days 0 and 30 were used for antibody titers and opsonophagocytic assays. Samples from day 7 were used for flow cytometric analysis.
Percentage of Polysaccharide Specific B Cells (% Cells/mL) % of CD19+ B cells that were PPS14+ post-immunization	2.12 percentage cells/mL Standard Deviation 0.99	1.55 percentage cells/mL Standard Deviation 1.29	1.68 percentage cells/mL Standard Deviation 0.75	1.82 percentage cells/mL Standard Deviation 1.11	1.67 percentage cells/mL Standard Deviation 0.92
Percentage of Polysaccharide Specific B Cells (% Cells/mL) % of CD19+ B cells that were PPS23F+ post-immunization	1.65 percentage cells/mL Standard Deviation 1.24	1.79 percentage cells/mL Standard Deviation 1.47	1.22 percentage cells/mL Standard Deviation 0.78	1.52 percentage cells/mL Standard Deviation 1.01	1.29 percentage cells/mL Standard Deviation 0.96
Percentage of Polysaccharide Specific B Cells (% Cells/mL) PPS14+ B cells that were IgM+ memory B cells day 7 post-immunization	18.73 percentage cells/mL Standard Deviation 16.12	22.95 percentage cells/mL Standard Deviation 19.53	20.57 percentage cells/mL Standard Deviation 8.49	24.59 percentage cells/mL Standard Deviation 15.58	20.62 percentage cells/mL Standard Deviation 10.2
Percentage of Polysaccharide Specific B Cells (% Cells/mL) % PPS14+ B cells that were switched memory B cells 7 d. post-immunization	41.48 percentage cells/mL Standard Deviation 17.31	51.6 percentage cells/mL Standard Deviation 25.31	51.23 percentage cells/mL Standard Deviation 17.72	52.46 percentage cells/mL Standard Deviation 19.22	44.87 percentage cells/mL Standard Deviation 18.33
Percentage of Polysaccharide Specific B Cells (% Cells/mL) %PPS23F+ B cells that were IgM memory B cells d7 post-immunization	30.56 percentage cells/mL Standard Deviation 12.34	14.67 percentage cells/mL Standard Deviation 8.44	24.21 percentage cells/mL Standard Deviation 16.66	32.22 percentage cells/mL Standard Deviation 24.95	18.11 percentage cells/mL Standard Deviation 10.97
Percentage of Polysaccharide Specific B Cells (% Cells/mL) % PPS23 F B cells that were switched memory B cells d.7 post-immunization	40.02 percentage cells/mL Standard Deviation 6.23	35.52 percentage cells/mL Standard Deviation 14.17	52.48 percentage cells/mL Standard Deviation 19.35	47.7 percentage cells/mL Standard Deviation 19.71	49.26 percentage cells/mL Standard Deviation 27.22
Percentage of Polysaccharide Specific B Cells (% Cells/mL) % of lymphocytes that are CD19+ (B cells)	9.87 percentage cells/mL Standard Deviation 5.85	5.31 percentage cells/mL Standard Deviation 2.31	9.75 percentage cells/mL Standard Deviation 4.05	7.91 percentage cells/mL Standard Deviation 3.25	10.77 percentage cells/mL Standard Deviation 4.4

SECONDARY outcome

Timeframe: Day 0 pre-immunization

Population: Participants who completed immunization and a minimal of 30 day follow up.

Measure level of inflammatory markers BAFF, APRIL, IL6, TNF alpha and sCD40L in serum in pg/mL pre-immunization.